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Authors: Edward Onusko, MD, Assistant Clinical Professor, Department of Family Medicine, University of Cincinnati College of Medicine, Associate Director, Clinton Memorial Hospital Family Practice Residency Program, Wilmington, Ohio; and Mini Pathrose, MD, Third-Year Resident Physician, Clinton Memorial Hospital Family Practice Residency Program, Wilmington, Ohio.
Editor’s Note—The challenge of providing primary pediatric health care services requires an up-to-date understanding of a broad range of preventive health issues. Most primary care physicians (PCPs) are aware that there are guidelines for the prescribing of fluoride supplements to children, but adequate knowledge of these recommendations and proper compliance with them is, in general, lacking.1 A historical review of the use of fluoride supplementation may give some insights into the applications of community-oriented primary care and evidence-based medicine in clinical practice. Current recommendations for prescribing are reviewed.
Co-sleeping means that an infant is sleeping in contact with or very close to another family member. The American Academy of Pediatrics acknowledges that there are advantages and disadvantages to co-sleeping. Physicians should help parents feel comfortable about their choice, whether it is for co-sleeping or sleeping separately in a crib. Many factors must be taken into account, such as the infant’s needs, the cultural milieu of the family, the current sleep environment, and the parental use of drugs, alcohol, and cigarettes. Parents need to know that the question of where their child should sleep has no absolute right or wrong answer.
Recent availability of a 7-valent conjugate pneumococcal vaccine (PCV7) has provided improved protection against invasive pneumococcal disease. The 2001 Recommended Childhood Immunization Schedule advises routine administration of PCV7 to all children at 2, 4, 6, and 12-15 months of age.
Existing scientific evidence demonstrates potential medical benefits of newborn male circumcision. These data, however, are not sufficient to recommend routine neonatal circumcision. It is necessary that the physician take into account the family’s cultural, religious, and ethnic traditions in addition to the medical factors involved. Anesthesia is safe and effective in reducing the procedural pain.
It is interesting to note that the beneficial effects of fluoride supplementation were discovered by the investigation of individuals manifesting its toxic effects. Frederick McKay noted in 1906 a characteristic mottling and discoloration of teeth he termed the "Colorado Brown Stain."2 It was observed that these stained teeth, though unsightly, were highly resistant to dental caries.3 Subsequent epidemiologic investigation led to the discovery in 1931 that high natural concentrations of fluoride in drinking water caused the mottling and the disorder was renamed "dental fluorosis."4 Studies by Dean in the 1930s of the geographic distribution of fluorosis demonstrated that a concentration of approximately one part per million (ppm) fluoride in the drinking water substantially protected against dental caries in the absence of noticeable enamel fluorosis.5 Community water fluoridation programs were introduced in 1945 in Grand Rapids, Mich, and Newburg, NY.4 Follow-up studies of these communities in the 1940s and early 1950s demonstrated a 50% reduction in dental caries when 1 ppm fluoride was added to the natural water supplies.
Fluoride is a natural element found at varying concentrations in all drinking water as well as soil.3 It is a beneficial nutrient that is important for the proper mineralization of bones and teeth. Its positive effects are summarized in Table 1.
|Table 1. Beneficial Effects of Optimal Levels of Fluoride|
|Increases tooth mineralization and bone density||Acts to stabilize the hydroxyapatite matrix on external and internal surfaces|
|Reduces the risk and prevalence of dental caries||Reduces acid production by oral plaque bacteria|
|Promotes enamel remineralization throughout life for individuals of all ages||Direct mineralizing effect on enamel|
Fluoridation of public water supplies has been promoted by a multitude of US and international health organizations as the most cost-effective dental public health intervention available. The presence of excess fluoride during enamel formation prior to tooth eruption, however, results in hypomineralization and abnormal enamel architecture (fluorosis). Mild fluorosis is clinically evidenced by paper-white streaking of enamel and for the most part is detectable only during dental examinations. Severe fluorosis may result in pitting and brown staining (from natural dyes found in foods) of the teeth, which is cosmetically objectionable. Mild-to-moderate forms of the disorder are much more common than severe fluorosis.
Chronic excessive fluoride exposure may rarely result in skeletal fluorosis, though only a handful of cases have been reported during the past 30 years.6
Because the initial studies demonstrated that the adverse effects of excess fluoride were secondary to exposure prior to eruption of the primary teeth, it was assumed for many years that the benefits of fluoride supplementation were on the basis of a pre-eruptive, systemic effect as well. Further research in the last decade has demonstrated that topical post-eruptive effects are the most important mechanisms for prevention of caries by fluoride supplemenation.3 Fluoride that is systemically absorbed (eg, from fluoridated water supplies or dietary supplements) is secreted in the saliva and therefore exerts a topical effect as well.
Thus the proper amount of dietary and/or topical fluoride supplementation will result in a decrease in dental caries without clinically significant fluorosis. The challenges for the PCP are to: 1) ascertain the current sources of supplementary fluoride the patient is receiving; 2) assess the risk for dental caries in the patient; 3) recommend fluoride supplements as indicated; 4) educate patients and their families concerning sources of and use of fluoride supplements; and 5) monitor adherence to recommendations.
There are a surprising number of sources of fluoride, as outlined in Table 2.
|Table 2. Sources of Fluoride|
|Artificially fluoridated drinking water||Toothpastes|
|Naturally fluoridated water*||Fluoride rinses, gels, varnishes (may be administered at dentist’s office or school-based programs)|
|Bottled water||Dietary fluoride supplements|
|Foods and beverages
prepared with fluoridated water
|Regional environmental fluoride contamination (eg, industrial emissions)|
|*Most bottled water sold in the United States does not contain significant concentrations of fluoride.|
Recommendations for fluoride supplementation are usually based primarily on age and fluoride content of drinking water (see Table 3).6
|Table 3. Schedule for Daily Fluoride Supplementation|
|Fluoride content of drinking water (in parts per million [ppm])|
|Child’s Age||< 0.3 ppm||0.3-0.6 ppm||> 0.6 ppm|
|birth to 6 months||0 mg||0 mg||0 mg|
|6 months-3 years||0.25 mg||0 mg||0 mg|
|3-6 years||0.50 mg||0.25 mg||0 mg|
|6-16 years||1.00 mg||0.50 mg||0 mg|
The US Public Health Service suggests supplementation of drinking water sources to levels of 0.7-1.2 ppm fluoride. Recommendations within this range are dependent on annual average of maximum daily air temperatures. It is estimated that populations in warmer climates will consume more water over the course of a year. Approximately 62% of the US population live in areas with central water supplies with sufficient (usually via supplementation) concentrations of fluoride. About 46% of public water supplies are still not fluoridated.3 Well water is known to vary tremendously in fluoride content. Home water treatment systems may affect the fluoride content of the filtered water. Reverse osmosis systems (usually located under the sink) and distillation units remove significant amounts of fluoride. Water softeners do not change fluoride levels.3 It is recommended by some authorities to test home water supplies before prescribing fluoride supplements.7 Bottled water supplies likewise have highly variable fluoride content, though most bottled water sold in the United States does not contain significant amounts of fluoride.8
There is also a halo effect resulting from consumption of beverages and foods produced in communities with fluoridated water.8 The reverse can also occur with consumption of beverages manufactured from low fluoride water supplies. Prior to 1979, infant formulas in the United States had high concentrations of fluoride.2 (Remember the previously presumed pre-eruptive benefits of fluoride!) Studies of children born before 1979 showed consumption of infant formula to be a risk factor for fluorosis, particularly in fluoridated communities. Despite the reduction of fluoride levels in infant formula preparations, however, subsequent studies of children born after 1979 demonstrated that use of powdered concentrate infant formulas prepared with fluoridated tap water was still a risk factor for fluorosis. This suggests that the PCP should recommend either ready-to-feed infant formula preparations or use of non-fluoride bottled water to dilute concentrated formulas. Although the concentration of fluoride in breast milk is low, fluoride should not be administered to infants during the first 6 months of life, whether they are breast- or formula-fed.9 During the period from 6 months to 3 years of age, both breastfed and formula-fed infants require fluoride supplementation only if the water supply contains less than 0.3 ppm fluoride.
Most fluoride dentifrices (toothpastes) for both adults and children contain sodium fluoride (0.15% fluoride ion). Several risk factors for fluorosis related to use of toothpaste have been identified (see Table 4).
|Table 4. Toothbrushing Behaviors Associated with Fluorosis|
|Use of fluoride toothpaste before age 2 years||Avoid use of fluoride toothpaste before age 2|
|Excess volume of toothpaste used||Use only a pea-sized volume of toothpaste; Adult supervision of toothbrushing; Development of dispensers that limit volume of toothpaste|
|Swallowing of excess fluoride while brushing||Adult supervision to ensure children rinse and expectorate|
|Excess topical exposure to fluoride||Limit brushing to twice a day prior to age 6; Make available low or no fluoride toothpastes|
The directions and warnings printed on most commercial toothpaste containers in the United States are shown in Figure 1.
|Figure 1. Information Displayed on Most US Commercial Toothpaste Products|
|USE: Helps protect against cavities. DIRECTIONS: Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Do not swallow. Children under 6 years: To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a dentist or physician. WARNINGS: Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.|
Yet manufacturers have produced "kids" style products with colorful packaging, displaying easily recognizable popular children’s characters. Sparkling colorful toothpaste comes oozing out of the tubes from "easy-dispense" containers.
Other sources of fluoride are concentrated fluoride rinses, gels, and varnishes. These may be administered in the dentist’s office or through school-based programs in communities with nonfluoridated water.
The use of fluorides and fluoridation for caries prevention is recommended by more than 90 professional health organizations. Many of these organizations endorse the supplementation schedule listed in Table 3. If the child’s drinking water is not from a municipal water supply of known fluoride concentration, ideally the drinking water sources should be tested for their fluoride content in order to properly comply with the prescribing schedule.2 In theory, a combination of dentrifice, diet, and oral supplements might result in excessive daily fluoride intake. In practice, the actual total dose of fluoride received via rinses at school, toothpaste, dietary sources, and oral supplements is very hard to quantify.8 The prescriber should be aware of other sources of fluoride to the child and educate the parents concerning risks of fluorosis.
Compliance with these recommendations has been consistently poor in the United States, however. About half of public water supplies are still not fluoridated, despite the US Public Health Service’s Healthy People 2000 goal of 95%.3 The revised goal for Healthy People 2010 is 75%.
There are still multiple barriers to compliance. One has been termed the "RIOT" syndrome—physicians or parents may not feel compliance is important because "Remember, It’s Only Teeth." Despite good evidence that public water fluoridation is a highly cost-effective measure, communities may choose not to incur the up-front cost involved. The direct annual cost of water fluoridation in the United States is about $.50/person/y. The range is $0.12-$5.41/person/y, depending on the size of the community.3
One barrier to compliance with the recommendations might be the reluctance of the practitioner to prescribe a potentially toxic (albeit mildly) substance to an asymptomatic population. We know that we have made errors in fluoride supplementation in the past (see Table 5).10
|Table 5. Historical Corrections in Fluoride Supplementation for Non-Fluoridated Water Communities|
|Previous Practices Not Currently Recommended||Rationale
|Date Initiated||Date Corrected|
supplementation prior to
age 6 months
|Fluoride benefits assumed to be pre-eruptive, risks of fluorosis not appreciated.||1979||1994|
|Oversupplementation in infant formulas||Risks of fluorosis at higher doses not appreciated.||Prior
|1.00 mg/d ages 3-13 years||Not appreciated that children younger than 6 years were at higher fluorosis risk.||1979||1994|
Although the current fluoride supplementation guidelines were formulated in 1994 based on the best evidence-based information available, there has been little evidence-based review of their safety vs. efficacy. More education about fluoride supplementation needs to be done at both the national and international levels in order to achieve improved compliance.
The Co-Sleeping Controversy
Co-sleeping may be defined as an infant sleeping either 1) in direct contact with another person (eg, in someone’s arms, passively touching while lying in bed); or 2) close enough to access, respond to, or exchange sensory stimuli (sound, movement, touch, vision, smell, temperature, or CO2). Regular co-sleeping in the United States is most common among Hispanic families (about 90%), intermediate among black families (70%), and lowest among white families (less than 10%).11
The earliest record of co-sleeping is from the Old Testament book of 1 Kings. Written about 950 BC, the account tells of 2 prostitutes who came before King Solomon to settle a dispute over which one of them had lost an infant because "during the night this woman’s son died because she lay on him the next morning, I got up to nurse my son—and he was dead!"12 Co-sleeping was the norm until the 1800s, when an appreciation of the germ theory of disease prompted an interest in the benefits of separate beds. It is only in the last 100 years that co-sleeping has not been the norm in the United States, though it remains common practice in most other countries. Table 6 lists factors that discouraged co-sleeping in the 1900s.13
6. Factors That Discouraged Co-Sleeping
in the 1900s
|•||The birthplace was moved from the home to the hospital.|
|•||Newborns were separated from their mothers in hospital nurseries.|
|•||The introduction of infant formulas decreased the frequency of breastfeeding.|
|•||Mothers moved into the workforce.|
|•||Homes became larger, with separate rooms for children.|
Table 7 contains some of the arguments for and against co-sleeping. Supporters of "child-guided parenting" believe that if a child’s needs aren’t met, he or she will have psychological problems. Supporters of "parent-guided parenting" maintain that the child should be allowed to cry and then comfort him- or herself so as to develop a sense of self-esteem and competence.13
|Table 7. The Co-Sleeping Controversy|
|Why Parents Do Co-Sleep|
|•||Makes frequent breastfeeding easy|
|•||Promotes physical and emotional closeness with infant|
|•||Decreases nighttime problems and fears|
|•||May reduce risk of SIDS (controversial)|
|•||Other favorable physiological effects (less hypoglycemia, fewer cardiac arrhythmias, cry less to initiate feedings)|
|Why Parents Don’t Co-Sleep|
|•||Can result in suffocation|
|•||May have adverse psychological effects such as "spoiling the infant"|
|•||May interfere with marital intimacy|
|•||May disturb adults’ sleep|
|•||May lead to disapproval by relatives or friends|
|•||May be opposed by spouse|
Benefits of Co-Sleeping
Makes breastfeeding easier. Infants who co-slept breastfed 3 times longer than infants who didn’t co-sleep. The composition of human breast-milk, when compared to milk from other primates, is lower in fats and proteins and higher in carbohydrates. This composition provides relatively fewer calories for feeding, suggesting that infants need to remain close to their mothers where they can nurse frequently.14 Although controversial, several studies have demonstrated that breastfeeding protects against SIDS and that the protective effect is dose related. It also affects the mother by promoting lactational amenorrhea.
Reduces risks of SIDS (controversial) by:14
• Temperature—Overbundling resulting in hyperthermia may be associated with SIDS deaths. A co-sleeping adult who is capable of manipulating the thermal environment as needed could decrease the chances of hyperthermia and the risk of SIDS. The responsivity of mother-to-infant arousals may be protective.
• Supine position—Co-sleeping babies are much more likely to sleep on their backs and sides than on their stomachs, thereby reducing the risk of SIDS.
• Movement—The frequent stimulation associated with parental respiration and body movements has been shown by McKenna to reduce the frequency of apneic pauses (defined as cessation of respiration lasting 4-30 seconds) in infants.14
• Altered chemical environment—Increased CO2 content (parental and infant respiration) may increase the respiratory drive, thereby reducing the risk of SIDS. This mechanism is speculative, as rebreathing of expired parental air is postulated by some as a cause of SIDS, as discussed below.
Risks of Co-sleeping
SIDS (controversial). We must carefully distinguish between infants dying from SIDS while co-sleeping and infants who are truly suffocated by another sleeper. Death scene investigation is crucial to accurately determine the cause of death. Postulated mechanisms include hypoxia due to rebreathing of parental expired air, airway obstruction, high room temperatures, overbundling, and maternal smoking. The New Zealand Cot Death Study found that bed sharing was a risk factor for SIDS among infants whose mothers smoked. These infants have deficient hypoxic arousal responses. Their arousal responses to thermal stress might also be blunted.
Suffocation by overlying and entrapment. The 8-year records from January 1990 through December 1997 collected by the US Consumer Product Safety Commission showed a total of 515 deaths of children younger than 2 years who were placed to sleep on adult beds. Of these deaths, 121 were reported to be due to overlying of the child by a parent, other adult, or sibling sleeping in bed with the child, and 394 were due to entrapment in the bed structure. This included 296 on regular adult beds, 79 on adult waterbeds, 10 on adult daybeds, and 9 on adult-sized beds fitted with bed rails. Parental sedation (including consumption of alcohol or drugs), obesity, and fatigue may predispose to accidental infantile asphyxia.16
Possible negative psychological effects (speculative). The literature on co-sleeping includes statements that it may:17
What does the American Academy of Pediatrics Recommend?
The American Academy of Pediatrics issued a policy statement in March 2000 on infant sleeping environment.18 Their expert panel found that while bed sharing may have certain benefits (such as encouraging breastfeeding), there is no basis at this time for encouraging bed sharing as a strategy to reduce SIDS risk. Their recommendations for bed-sharing parents include:
• As an alternative to bed sharing, parents might consider placing the infant’s crib near their bed to allow for more convenient breastfeeding and parental contact.
• If a mother chooses to have her infant sleep in her bed to breastfeed, care should be taken to: a) put the baby in a nonprone sleep position; b) avoid soft surfaces or loose covers; c) avoid entrapment by moving the bed away from the wall and other furniture; and d) avoid beds that present entrapment possibilities.
• Adults other than the parents, children, or other siblings should avoid bed sharing with an infant.
• Parents who choose to bed share with their infant should not smoke or use substances such as alcohol or drugs that may impair arousal.
Prevention of Pneumococcal Infections
Pneumococcal vaccine. The bacterium Streptococcus pneumoniae (pneumococcus) has long been a leading cause of morbidity and mortality worldwide.19 It was reported in 1997 that this organism accounted for 3000 cases of meningitis, 50,000 cases of bacteremia, 5,000,000 cases of pneumonia, and 7,000,000 cases of otitis media in the United States per year.20 Early studies of pneumococcus demonstrated that the polysaccharide capsule was the major virulence factor. It was found that serotype-specific, anticapsular antibodies could be generated by immunization that provided protection against pneumococcal disease.21 Pneumococcal vaccines were first available in the United States in 1946, but were withdrawn from the market because of the expected greater efficacy of the newly available penicillin and sulfa antibiotics. Increasing antibiotic resistance of the organism, as well as a renewed interest in prevention rather than treatment of illness, resulted in a 14-valent pneumococcal polysaccharide vaccine approved for use by the Food and Drug Administration (FDA) in 1977. This was replaced in 1983 by the currently used 23-valent polysaccharide vaccines (Pneumovax 23 and Pnu-Imune 23).
The disadvantages to the polysaccharide vaccines, however, are noted in Table 8.22
|Table 8. Disadvantages of Pneumococcal Polysaccharide Vaccines|
|•||Poor immunogenic response in children younger than 2 years|
|•||May not be immunogenic for all 23 serotypes until children are 5 years or older|
|•||Lack of reduction of nasopharyngeal carriage of pneumococcus|
|•||Lack of T-cell mediated immune response|
|•||Lack of anemnestic (memory) response after booster doses|
The search for a more effective pneumococcal vaccine was advanced by the spectacular success in the development of the Haemophilus influenzae B (Hib) conjugate vaccines.23 The polysaccharide antigens were chemically linked (conjugated) to a protein carrier to increase the immune response. This conjugate vaccine resulted in a marked reduction in Hib disease, particularly reducing meningitis in children younger than 2 years. Three different proteins are being used currently in various preparations of conjugate Hib vaccine. One of these proteins, a mutant nontoxic diphtheria toxin, CRM197, has been used in a 7-valent pneumococcal vaccine licensed in February 2000 (Prevnar—Wyeth/Lederle).24 Although there are about 90 different capsular serotypes among the pneumococcal strains, these 7 serotypes caused the majority of clinical cases of invasive pneumococcal disease (bacteremia and meningitis), pneumonia, and otitis media.25 Unlike the Hib conjugate vaccines, there are more technological limitations in the number of serotypes that can be included in the pneumococcal vaccine, based in part on the large amount of pneumococcal polysaccharide and carrier protein that would be required in even a 23-valent conjugate vaccine.26 The protein conjugate vaccine overcomes all 5 of the deficiencies of the polysaccharide vaccine (poor response in those younger than age 2 years, etc) listed in Table 8. Its immunogenicity has been demonstrated by: a) measurement of serum antibody concentrations; b) persistence of antibodies over time; c) demonstration of functional ability of the antibodies; and d) clinical efficacy.27
A double-blind randomized trial of 37,868 infants was conducted in California at Northern Kaiser Permanente using the conjugate heptavalent pneumococcal vaccine (PCV7).28 The vaccine was found to be highly efficacious (97% at the 8-month follow-up analysis for serotypes included in the vaccine) for the prevention of invasive pneumococcal disease. The number of episodes of otitis media was not significantly reduced overall, but in those children with a history of frequent episodes of otitis media, the incidence was reduced by 23%. Children who received the pneumococcal vaccine were about 20% less likely to require myringotomy tube placement.20 A prospective open trial conducted of 22 children and adolescents who were documented nonresponders to the 23-valent pneumococcal polysaccharide vaccine showed the 7-valent conjugate vaccine to be more immunogenic in this group, suggesting its use as a strategy to protect high-risk patients.29
The 2001 Recommended Childhood Immunization Schedule (approved jointly by the Advisory Committee on Immunization Practices of the Center for Disease Control, the American Academy of Pediatrics, and the American Academy of Family Physicians) advises routine administration of PCV7 to all children at 2, 4, 6, and 12-15 months of age.30 Dosing schedules are given in Table 9.
|Table 9. Recommended Schedule of Doses for Pneumococcal Conjugate Vaccine (PCV7)|
|Age at First Dose||Primary Series||Booster Dose|
|2-6 mo||3 doses, 6-8 wk apart||1 dose at 12-15 mo of age|
|7-11 mo||2 doses, 6-8 wk apart||1 dose at 12-15 mo of age|
|12-23 mo||2 doses, 6-8 wk apart|
|> 24 mo||1 dose|
| Booster doses to be given at least 6-8 weeks after the final dose of the primary series.|
Currently, there are insufficient data on safety and efficacy on which to base a recommendation for universal vaccination of children older than 24 months, other than those who are at high risk (see Table 10).30
|Table 10. Children at High Risk of Invasive Pneumococcal Infection|
|High risk (attack rate of invasive pneumococcal disease > 150/100,000 cases/y)|
|•||Sickle cell disease, congenital or acquired asplenia, or splenic dysfunction|
|•||Infection with HIV|
|Presumed high risk (attack rate not calculated)|
|•||Congenital immune deficiency|
|•||Chronic cardiac disease (particularly cyanotic congenital heart disease and cardiac failure)|
|•||Chronic pulmonary disease (including asthma treated with high-dose oral corticosteroid therapy)|
|•||Cerebrospinal fluid leaks|
|•||Chronic renal insufficiency, including nephrotic syndrome|
|•||Diseases associated with immunosuppressive therapy or radiation therapy (including malignant neoplasms, leukemias, lymphomas, and Hodgkin’s disease) and solid organ transplantation|
|Moderate risk (attack rate of invasive pneumococcal disease > 20 cases/100,000/y)|
|•||All children 24-35 mo old|
|•||Children 36-59 mo old attending out-of-home care|
|•||Children 36-59 mo old who are of Native American (American Indian and Alaska Native) or African American descent|
A recent analysis of the epidemiology of pneumococcal disease in the United States from 1995-1998 emphasized the importance of prevention in children younger than 2 years, blacks of all ages, the elderly, and persons with chronic illnesses.31 Table 11 summarizes the recommendations of the Committee on Infectious Diseases of the American Academy of Pediatrics vaccine use of 23-valent polysaccharide and 7-valent conjugate pneumococcal vaccine in children older than 23 months.30 PCV7 vaccine may be administered safely at the same time as the other routine childhood immunizations.
|Table 11. Recommendations for Pneumococcal Immunization with Conjugate (PCV7) or Polysaccharide (23PS) Vaccine for Children at High Risk of Pneumococcal Disease, as Defined in Table 10.|
|< 23 mo||None||PCV7 as in Table 9|
|24-59 mo||4 doses of PCV7||1 dose of 23PS vaccine at 24 mo, at least 6-8 wk after last dose of PCV7|
|1 dose of 23PS vaccine, 3-5 y after the first dose of 23PS vaccine|
|24-59 mo||1-3 doses of PCV7||1 dose of PCV7|
|1 dose of 23PS vaccine, 6-8 wk after the last dose of PCV7|
|1 dose of 23PS vaccine, 3-5 y after the first dose of 23PS vaccine|
|24-59 mo||1 dose of 23PS||2 doses of PCV7, 6-8 wk apart, beginning at least 6-8 wk after last dose of 23PS vaccine|
|1 dose of 23PS vaccine, 3-5 y after the first dose of 23PS vaccine|
|24-59 mo||None||2 doses of PCV7 6-8 wk apart|
|1 dose of 23PS vaccine, 6-8 wk after the last dose of PCV7|
|1 dose of 23PS vaccine, 3-5 y after the first dose of 23PS vaccine|
One study of persons older than 24 months old with sickle cell disease demonstrated that a combined schedule of 7-valent pneumococcal conjugate vaccine followed by 23-valent vaccine resulted in higher pneumococcal antibody concentrations than immunization with the 23-valent vaccine alone.32 In general, pneumococcal vaccines should be deferred during pregnancy. Despite the recommendation for routine use of the PCV7 vaccine, its cost-effectiveness is still somewhat debatable.33,34 Direct cost from the manufacturer is $58 per dose.
Use of pneumococcal vaccine in children with severe or recurrent otitis media is controversial.35 The polysaccharide vaccines have not reduced the incidence of acute otitis media (AOM) at any age. The PCV7 may be modestly beneficial (< 10% reduction) in prevention of AOM for 1) all infants younger than 24 months old; and 2) children ages 24-59 months old who have a history of recurrent AOM (defined as 3 or more episodes in 6 months, or 4 or more episodes in a year) or tympanostomy tube placement.25,30 A recently published study of 1662 subjects from Finland demonstrated that the PCV7 did not reduce the overall incidence of AOM.36
Antibiotic prophylaxis against pneumococcus. In addition to pneumococcal immunization, antibiotic prophylaxis is recommended for all children with sickle cell disease or asplenia (functional or anatomic) beginning before 2 months of age or as soon as these diagnoses are made.30 Penicillin VK 125 mg by mouth twice a day until age 3 years is recommended, then 250 mg twice a day after age 3 years. Children who have not had an episode of invasive pneumococcal infection and who have received recommended pneumococcal immunizations may discontinue penicillin prophylaxis after 5 years of age.
It is estimated that 1.2 million newborn males are circumcised in the United States annually (approximately 64% of newborn males) at a cost of between $150-270 million. But behind these statistics, there rages a debate about whether the procedure should be done at all. There are those who view circumcision—the surgical removal of the foreskin of the penis, usually done within days after birth—as barbaric genital mutilation, and those who believe it is a necessity for medical, cultural, or religious reasons. The medical reasons most commonly given for circumcision are listed in Table 12.
|Table 12. Potential Medical Benefits of Neonatal Circumcision|
|•||Prevent phimosis, paraphimosis, and balanitis|
|•||Decrease the risk of cancer of the penis|
|•||Decrease the risk of UTI in infants|
|•||Decrease the risk of sexually transmitted diseases|
|•||Enhance sexual function|
In their policy statement released in March 1999, the Task Force on Circumcision of the American Academy of Pediatrics didn’t find sufficient data to recommend routine neonatal circumcision. They recommended that parents should determine what is in the best interests of their child. To make an informed choice, parents of all male infants should be provided the opportunity to discuss this decision with their physician. They should be given accurate and unbiased information on the potential benefits and risks of the procedure. If a decision for circumcision is made, it should only be done on infants who are stable and healthy, and procedural analgesia should be provided.37
Potential Benefits of Circumcision
Circumcision and urinary tract infection (UTI) in infant males. Numerous studies suggest that uncircumcised male infants are 10 times more likely than circumcised infants to experience a UTI in the first year of life. (An uncircumcised male infant has a 1 in 100 chance of developing a UTI during the first year of life; a circumcised male has only a 1 in 1000 chance.) Increased periurethral bacterial colonization may be a risk factor for UTI. During the first 6 months of life, there are more uropathogenic organisms around the urethral meatus of uncircumcised male infants, but this colonization decreases in both groups after the first 6 months. In addition, it was demonstrated in an experimental preparation that uropathogenic bacteria adhered to and readily colonized the mucosal surface of the foreskin but didn’t adhere to the keratinized skin surface of the foreskin. Acute pyelonephritis in the first year of life may lead to significant renal damage that may progress to end stage renal disease during adolescence. The largest and best designed North American study followed a cohort of 58,000 Canadian boys and showed a decrease in hospital admissions for UTI from 7.02 per 1000 uncircumcised boys to 1.88 per 1000 circumcised boys.38
However, To et al concluded that studies have overestimated the risk of UTI in uncircumcised boys. They hypothesize that about 195 circumcisions would need to be performed in order to prevent one hospital admission for UTI.39
Circumcision and Cancer of the Penis. There is an at least 3-fold increased risk of penile cancer in uncircumcised men. Phimosis, a condition that exists only in uncircumcised men, increases this risk further. Other risk factors identified include "previous genital condition," genital warts, > 30 sexual partners, and cigarette smoking. The rate of penile cancer in the United States is 0.9 to 1 per 100,000 males. In countries where the majority of the men are uncircumcised, the rate of penile cancer varies (from 0.82 per 100,000 in Denmark, to 2.9-6.8 per 100,000 in Brazil, and 2.0-10.5 per 100,000 in India). In the United States, the risk of penile cancer developing in an uncircumcised man, although increased compared with a circumcised man, is still low.37
Circumcision and Sexually Transmitted Diseases (STDs). Roberts et al reported that "male circumcision consistently shows a protective effect against human immunodeficiency virus (HIV) infection," with an 8-fold increased rate of HIV among uncircumcised men. They further reported a greater incidence of HIV in sexual partners of uncircumcised men. A study of HIV in Kenya where homosexuality is uncommon showed that the risk of testing positive for HIV was 2.7 times greater for uncircumcised men than for circumcised men.40 The mucous membrane of the uncircumcised penis allows for viral attachment to lymphoid cells at or near the surface of the mucous membrane, as well as increased likelihood of minor abrasions, resulting in increasing HIV access to target tissues. Human papilloma virus (HPV), which plays an important role in the pathogenesis of cervical cancer, is also sexually transmitted, although men are frequently asymptomatic. Several studies have shown that women whose sexual partners are uncircumcised are at increased risk for cervical cancer secondary to HPV. However, one has to remember that behavioral factors appear to be far more important risk factors in the acquisition of STDs than circumcision status. Chlamydial infections, nongonococcal urethritis, and genital herpes are equally prevalent in circumcised and uncircumcised men.
Circumcision and sexual function. Laumann et al suggest that circumcised men have slight benefit in terms of sexual satisfaction and less likelihood of sexual dysfunction. A 1988 survey of women reported female sexual preference for circumcised men.
There are anecdotal reports that penile sensation and sexual satisfaction are decreased for circumcised males. It is suggested that surgical removal of the prepuce results in the loss of a majority of the fine touch neuroreceptors found in the penis, leaving only the exposed glands, which is innervated with free nerve endings that can only sense deep pressure and pain. More studies are required to explore both these schools of thought.41
Risks of Circumcision
The complication rate of the procedure is between 0.2% and 0.6%. The complication rate is inversely related to operator experience. Bleeding is the most frequent complication followed by infection. Other complications such as recurrent phimosis, wound separation, concealed penis, unsatisfactory cosmesis because of excess skin, urinary retention, meatitis, meatal stenosis, chordee, and inclusion cysts are extremely rare.
Methods of Circumcision
The Gomco clamp, the Plastibell device, and the Mogen clamp are the 3 common methods used for newborn circumcision. EMLA cream (containing 2.5% lidocaine and 2.5% prilocaine), dorsal penile nerve block, and subcutaneous ring block are anesthetic options that have documented efficacy in pain relief in neonatal circumcision.37 Acetaminophen may provide analgesia in the immediate postoperative period. When the complication rates were compared, neonatal circumcision had a complication rate of 0.2% and childhood circumcision had a rate of 1.7%. The cost of circumcision performed in the neonatal period was much less than when performed later in childhood because of additional operating room costs, anesthesia, and surgeon’s fees, etc.
Circumcision and Ethical Issues
The practice of medicine should respect the rights of adults to self-determination in health care decision making. Some advocate that in the United States, where parents are afforded wide authority for determining what constitutes appropriate child rearing and child welfare, it is legitimate for parents to take into account cultural, religious, and ethnic traditions, in addition to medical factors, when making the choice about newborn circumcision.
Others believe that circumcision subjects male infants to an invasive procedure that they might well reject if they were old enough to consider its risks and benefits. They argue that the surgical ablation of the foreskin prior to the age of consent infringes on one of the most basic human rights, namely the right of physical integrity. From this perspective, the performance of routine newborn circumcision by the medical profession in the United States allows this form of "genital mutilation" to remain culturally acceptable—and even desirable! They believe that men should make the decision about circumcision for themselves when they reach adulthood.42
How parents make the decision about circumcision. Few parents are aware of the medical debate over circumcision. Most make their decisions based on concerns of appearance, hygiene, convenience, and history of the father being circumcised.43 Most parents decide before they discuss it with their physician, and the physician’s opinions do not significantly affect their decision. Health professionals appeared to have had more influence on those who decided against circumcision. The most common reasons for not choosing circumcision were related to beliefs that it’s not necessary, that it is painful and that the father wasn’t circumcised. The most influential person helping women to make the decision was the father of the baby.
Circumcision Policy Statement of the American Academy of Pediatrics (1999)
Existing scientific evidence demonstrates potential medical benefits of newborn male circumcision; however, these data are not sufficient to recommend routine neonatal circumcision. In the case of circumcision, in which there are potential benefits and risks (yet the procedure is not essential to the child’s current well being), parents should determine what is in the best interest of the child. To make an informed choice, parents of all male infants should be given accurate and unbiased information and be provided the opportunity to discuss this with their physicians. It is legitimate for parents to take into account cultural, religious, and ethnic traditions in addition to the medical factors when making this decision. Analgesia is safe and effective in reducing the procedural pain. If a decision is made to perform circumcision in the newborn period, it should only be done on infants who are stable and healthy.
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