Before 2015, major changes in Neonatal Resuscitation Program (NRP) recommendations not supporting previously endorsed antepartum, intrapartum and postpartum interventions to prevent meconium aspiration syndrome were based on adequately powered multicenter randomized controlled trials. The 2015 and 2020 American Heart Association guidelines and 7th and 8th edition of NRP suggest not performing routine intubation and tracheal suctioning of nonvigorous meconium-stained newborns. However, this was given as a weak recommendation with low-certainty evidence. The purpose of this review is to summarize the evidence and explore the question of appropriate delivery room management for nonvigorous meconium-stained newborns.
A common disorder managed in the neonatal intensive care unit (NICU) is neonatal encephalopathy (NE). There are multiple causes of NE, including hypoxic-ischemic encephalopathy (HIE) and the fetal inflammatory response syndrome (FIRS). It is important to ascertain the specific cause of NE in an affected child, as it may affect the clinical management and will assist in prognostication. This paper discusses the background of inflammatory damage to the fetal brain, the history of FIRS as a clinical diagnosis, the characteristics of infants with FIRS, and methods to evaluate the etiology of NE.
It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.
It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent. Pediatrics 2014;134:1–7 AUTHORS: Mark S. Schreiner, MD,ab Dalia Feltman, MD,cd Thomas Wiswell, MD,e Susan Wootton, MD,f Cody Arnold, MD, MS,f Jon Tyson, MD, MPH,f and John D. Lantos, MDgh aThe Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania; bPerelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; cNorthshore Evanston Hospital, Evanston, Illinois; dUniversity of Chicago Pritzker School of Medicine, Chicago, Illinois; eFlorida Hospital Orlando, Orlando, Florida; fUniversity of Texas at Houston, Houston, Texas; gUniversity of Missouri–Kansas City, Kansas City, Missouri; and hChildren’s Mercy Hospital, Kansas City, Missouri
The objective of this review was to assess the trend in the US male circumcision rate and the impact that the affirmative 2012 American Academy of Pediatrics policy statement might have on neonatal circumcision practice. We searched PubMed for the term circumcision to retrieve relevant articles. This review was prompted by a recent report by the Centers for Disease Control and Prevention that found a slight increase, from 79% to 81%, in the prevalence of circumcision in males aged 14 to 59 years during the past decade. There were racial and ethnic disparities, with prevalence rising to 91% in white, 76% in black, and 44% in Hispanic males. Because data on neonatal circumcision are equivocal, we undertook a critical analysis of hospital discharge data. After correction for underreporting, we found that the percentage had declined from 83% in the 1960s to 77% by 2010. A risk-benefit analysis of conditions that neonatal circumcision protects against revealed that benefits exceed risks by at least 100 to 1 and that over their lifetime, half of uncircumcised males will require treatment for a medical condition associated with retention of the foreskin. Other analyses show that neonatal male circumcision is cost-effective for disease prevention. The benefits of circumcision begin in the neonatal period by protection against infections that can damage the pediatric kidney. Given the substantial risk of adverse conditions and disease, some argue that failure to circumcise a baby boy may be unethical because it diminishes his right to good health. There is no long-term adverse effect of neonatal circumcision on sexual function or pleasure. The affirmative 2012 American Academy of Pediatrics policy supports parental education about, access to, and insurance and Medicaid coverage for elective infant circumcision. As with vaccination, circumcision of newborn boys should be part of public health policies. Campaigns should prioritize population subgroups with lower circumcision prevalence and a higher burden of diseases that can be ameliorated by circumcision.
Purpose: Urinary tract infection is common in infant males who are uncircumcised and can lead to renal parenchymal disease of the still growing pediatric kidney. Although the rate of urinary tract infection is highest in the first year of life, the cumulative incidence during the rest of the lifetime is under-recognized, but is expected to be nontrivial. Thus, any intervention that might prevent urinary tract infection would be expected to reduce suffering and medical costs.Materials and Methods: We conducted a meta-analysis of 22 studies examining the single risk factor of lack of circumcision, then determined the prevalence and relative risk of urinary tract infection in different age groups (0 to 1, 1 to 16 and older than 16 years). From these data we estimated the lifetime prevalence.Results: For age 0 to 1 year the relative risk was 9.91 (95% CI 7.49-13.1), for age 1 to 16 years RR was 6.56 (95% CI 3.26-13.2) and for older than 16 years it was 3.41-fold (95% CI 0.916-12.7) higher in uncircumcised males. We then calculated that 32.1% (95% CI 15.6-49.8) of uncircumcised males experience a urinary tract infection in their lifetime compared with 8.8% (95% CI 4.15-13.2) of circumcised males (RR 3.65, 95% CI 1.15-11.8). The number needed to treat was 4.29 (95% CI 2.20-27.2).Conclusions: The single risk factor of lack of circumcision confers a 23.3% chance of urinary tract infection during the lifetime. This greatly exceeds the prevalence of circumcision complications (1.5%), which are mostly minor. The potential seriousness of urinary tract infection supports circumcision as a desirable preventive health intervention in infant males.
In a recent issue of the Journal of Medical Ethics, Svoboda and Van Howe commented on the 2012 change in the American Academy of Pediatrics (AAP) policy on newborn male circumcision, in which the AAP stated that benefits of the procedure outweigh the risks. Svoboda and Van Howe disagree with the AAP conclusions. We show here that their arguments against male circumcision are based on a poor understanding of epidemiology, erroneous interpretation of the evidence, selective citation of the literature, statistical manipulation of data, and circular reasoning. In reality, the scientific evidence indicates that male circumcision, especially when performed in the newborn period, is an ethically and medically sound low-risk preventive health procedure conferring a lifetime of benefits to health and well-being. Policies in support of parent-approved elective newborn circumcision should be embraced by the medical, scientific and wider communities.
Ten million or more newborns worldwide each year need some type of resuscitation assistance. More than 1 million babies die annually from complications of birth asphyxia. Over the past 3 decades, neonatal resuscitation has evolved from disparate, word-of-mouth teaching methods to organized programs. The most widely-used curriculum is the Neonatal Resuscitation Program, which is supported by the American Academy of Pediatrics and the American Heart Association. To date more than 1.5 million individuals have been trained in the Neonatal Resuscitation Program. Resuscitation efforts are geared toward avoiding or mitigating the adverse sequelae of asphyxia neonatorum. Certain characteristics distinguish the preterm infant, including propensity to become hypothermic and higher potential for adverse neurologic and pulmonary complications from resuscitation efforts. In this era of evidence-based medicine the most recent Neonatal Resuscitation Program guidelines were developed to provide recommendations based on the best currently-available science. A number of major proposals received considerable scrutiny during the evaluation process. Many areas of neonatal resuscitation still need to be studied.
Background: Circumcision is a common procedure, but regional and societal attitudes differ on whether there is a need for a male to be circumcised and, if so, at what age. This is an important issue for many parents, but also pediatricians, other doctors, policy makers, public health authorities, medical bodies, and males themselves.Discussion: We show here that infancy is an optimal time for clinical circumcision because an infant's low mobility facilitates the use of local anesthesia, sutures are not required, healing is quick, cosmetic outcome is usually excellent, costs are minimal, and complications are uncommon. The benefits of infant circumcision include prevention of urinary tract infections (a cause of renal scarring), reduction in risk of inflammatory foreskin conditions such as balanoposthitis, foreskin injuries, phimosis and paraphimosis. When the boy later becomes sexually active he has substantial protection against risk of HIV and other viral sexually transmitted infections such as genital herpes and oncogenic human papillomavirus, as well as penile cancer. The risk of cervical cancer in his female partner(s) is also reduced. Circumcision in adolescence or adulthood may evoke a fear of pain, penile damage or reduced sexual pleasure, even though unfounded. Time off work or school will be needed, cost is much greater, as are risks of complications, healing is slower, and stitches or tissue glue must be used.Summary: Infant circumcision is safe, simple, convenient and cost-effective. The available evidence strongly supports infancy as the optimal time for circumcision.
Respiratory distress syndrome (RDS) is a significant cause of morbidity and mortality in preterm infants. RDS is caused by a deficiency, dysfunction, or inactivation of pulmonary surfactant. Numerous surfactants of either animal extract or synthetic design have been shown to improve outcomes. New surfactant preparations that include peptides or whole proteins that mimic endogenous surfactant protein have recently been developed and tested. To assess the effect of administration of synthetic surfactant containing surfactant protein mimics compared to animal derived surfactant extract on the risk of mortality, chronic lung disease, and other morbidities associated with prematurity in preterm infants at risk for or having RDS. Standard search methods of the Cochrane Neonatal Review Group were used. The search included MEDLINE (1966 - May 2007) and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) in all languages. In addition, published abstracts of the Society of Pediatric Research were searched electronically. For abstract books that did not include key words, the search was limited to the relevant sections on pulmonary and neonatology. The bibliography cited in each publication was obtained and searched in order to identify additional relevant articles. Randomized and quasi-randomized controlled clinical trials were considered for this review. Studies that enrolled preterm infants or low birth weight infants at risk for or having RDS who were treated with either a synthetic surfactant containing surfactant protein mimics or an animal-derived surfactant preparation were included for this review. Studies that either attempted to treat or prevent respiratory distress syndrome were included. Primary outcome measures, including mortality, chronic lung disease and multiple secondary outcome measures were abstracted by the reviewers. Statistical analysis was performed using Review Manager software. Categorical data was analyzed using relative risk, risk difference, and number needed to treat. 95% confidence intervals reported. A fixed effects model was used for the meta-analysis. Heterogeneity was assessed using the I-squared statistic. Two studies were identified that compared protein containing synthetic surfactants to animal derived surfactant preparations. In a meta-analysis of these two studies, infants who received protein containing synthetic surfactant compared to animal derived surfactant extract did not demonstrate significantly different risks of prespecified primary outcomes: mortality at 36 weeks [typical RR 0.81 (95% CI 0.64, 1.03)], chronic lung disease at 36 weeks [typical RR 0.99 (95% CI 0.84, 1.18)], or the combined outcome of mortality or chronic lung disease at 36 weeks [typical RR 0.96 (95% CI 0.82, 1.12)]. There were also no differences in any of the secondary outcomes regarding complications of prematurity between the two surfactant groups with the exception of necrotizing enterocolitis. A decrease in the risk of necrotizing enterocolitis was noted in infants who received protein containing synthetic surfactants compared to animal derived surfactant extract [typical RR 0.60 (95% CI 0.42, 0.86)]. However, this was a secondary outcome in both of the primary studies and there was moderate heterogeneity between the studies. In two trials of protein containing synthetic surfactants compared to animal derived surfactant extract, no statistically different clinical differences in death and chronic lung disease were noted. In general, clinical outcomes between the two groups were similar. Further well designed studies of adequate size and power will help confirm and refine these findings. Protein containing synthetic surfactant versus animal derived surfactant extract for the prevention and treatment of respiratory distress syndrome Respiratory distress syndrome (RDS) is a significant cause of illness in preterm infants. Respiratory distress syndrome is caused by a deficiency or a dysfunction of the chemicals that line the lung, called pulmonary surfactant. Numerous preparations that contain surfactants of either animal origin or synthetic design have been developed and tested to treat or prevent respiratory distress syndrome. In general, these surfactant preparations have decreased lung rupture (pneumothorax), decreased the risk of dying, and increased the number of survivors without lung damage. From previous research, the surfactants that are obtained from animals seem to have a better effect than the synthetic surfactants. This might be due to the surfactant proteins contained in animal surfactant that are absent in the previously available synthetic surfactants. Recently developed synthetic surfactant preparations include whole surfactant proteins or parts of the proteins (called peptides) that act like surfactant protein. These preparations have been recently tested in comparison to the animal derived surfactant preparations. Two recent trials of protein containing synthetic surfactant compared to animal derived surfactant preparations have demonstrated a trend towards decreasing death and decreasing rates of bowel disease (necrotizing enterocolitis), while other clinical outcomes were similar. Further studies will help refine recommendations concerning use of protein containing synthetic surfactants.
We applaud Leibowitz et al. for describing the adverse impact on public health of the withdrawal by 16 states of Medicaid coverage for male circumcision.1 However, we are alarmed by a subsequent letter by anticircumcision lobbyists, in which the evidence regarding circumcision is thoroughly misrepresented.2 Their claims flatly contradict the bulk of the legitimate medical literature demonstrating that male circumcision protects against urinary tract infections, HIV, HSV-2, syphilis, chancroid, thrush, bacterial accumulation, human papillomavirus, penile (and possibly prostate) cancer, local inflammation (balanitis), phimosis, paraphimosis, sexual problems with age, and, in female partners, human papillomavirus, cervical cancer, HSV-2, chlamydia, and bacterial vaginosis.3 The evidence for several of these conditions now includes data from randomized controlled trials and rigorous meta-analyses. Two recent randomized controlled trials also show no adverse effect on sensitivity, sexual function, or satisfaction.4 Risks associated with medical circumcision of infants are extremely low (0.3%–0.6%) and the majority of complications are minor and easily treated.3 Moreover, this procedure remains as popular as ever in the United States, with the majority of male infants being circumcised. Green et al. display a disturbing lack of understanding of basic epidemiology. A valid test of whether circumcision protects against HIV infection or penile cancer is not by comparing rates between different countries! Moreover, the flaws in their arguments denying circumcision's protection against HIV infection have been exposed previously in a detailed 48-author commentary.5 In contrast to their claim about applicability of data from Africa to the United States, the degree of protection that circumcision affords against heterosexual HIV infection confirmed in 3 large randomized controlled trials is now observed in heterosexual men in the United States.6 This protection probably extends, moreover, to insertive anal intercourse.7 Circumcision also protects against urinary tract infections throughout life.8 The accumulated lifetime prevalence in US men is up to 14%.9 But the highest rate (1%–4%) is during infancy, where circumcision affords a 10-fold protective effect.3 This is observed consistently in the literature. Properly conducted cost-benefit analyses have indicated that, over a man's lifetime, infant circumcision provides a positive cost benefit, especially when diseases and medical problems in female partners are also considered.10 In this new political era in the United States, with its hope for better health care generally, Medicaid coverage for circumcision is a health care parity right of the poor. It must be retained by the majority of states, and must be reinstated by those states that have previously withdrawn it.
BACKGROUND:Respiratory distress syndrome (RDS) is a significant cause of morbidity and mortality in preterm infants. RDS is caused by a deficiency, dysfunction, or inactivation of pulmonary surfactant. Numerous surfactants of either animal extract or synthetic design have been shown to improve outcomes. New surfactant preparations that include peptides or whole proteins that mimic endogenous surfactant protein have recently been developed and tested. OBJECTIVES:To assess the effect of administration of synthetic surfactant containing surfactant protein mimics compared to protein free synthetic surfactant on the risk of mortality, chronic lung disease, and other morbidities associated with prematurity in preterm infants at risk for or having RDS. SEARCH STRATEGY:Standard search methods of the Cochrane Neonatal Review Group were used. The search included MEDLINE (1966 - March 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) in all languages. SELECTION CRITERIA:Randomized and quasi-randomized controlled clinical trials were considered for this review. Studies that enrolled preterm infants or low birth weight infants at risk for or having RDS who were treated with either a synthetic surfactant containing surfactant protein mimics or a protein free synthetic surfactant were included for this review. Studies of treatment or prevention of respiratory distress syndrome were included. DATA COLLECTION AND ANALYSIS:Data regarding mortality, chronic lung disease and multiple secondary outcome measures were abstracted by the review authors. Statistical analysis was performed using Review Manager software. Categorical data were analyzed using relative risk, risk difference, and number needed to treat. 95% confidence intervals reported. A fixed effects model was used for the meta-analysis. Heterogeneity was assessed using the I(2) statistic. MAIN RESULTS:One study was identified that compared protein containing synthetic surfactants (PCSS) to protein free synthetic surfactants. Infants who received protein containing synthetic surfactant compared to protein free synthetic surfactant did not demonstrate significantly different risks of prespecified primary outcomes: mortality at 36 weeks postmenstrual age (PMA) [RR 0.89 (95% CI 0.71, 1.11)], chronic lung disease at 36 weeks PMA [RR 0.89 (95% CI 0.78, 1.03)], or the combined outcome of mortality or chronic lung disease at 36 weeks PMA [RR 0.88 (95% CI 0.77, 1.01)]. Among the secondary outcomes, a decrease in the incidence of respiratory distress syndrome at 24 hours of age was demonstrated in the group that received PCSS [RR 0.83 (95% CI 0.72, 0.95). AUTHORS' CONCLUSIONS:In the one trial comparing protein containing synthetic surfactants compared to protein free synthetic surfactant for the prevention of RDS, no statistically different clinical differences in death and chronic lung disease were noted. Clinical outcomes between the two groups were generally similar although the group receiving protein containing synthetic surfactants did have decreased incidence of respiratory distress syndrome. Further well designed studies comparing protein containing synthetic surfactant to the more widely used animal derived surfactant extracts are indicated.
Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is one of the most challenging complications in premature infants. The incidence of BPD has been increasing over the past two decades in parallel with an improvement in the survival of this population. Furthermore, the clinical characteristics and the natural history of infants affected by BPD have changed considerably, and newer definitions to clarify the term 'BPD' have also evolved since its first description more than four decades ago. Several drug therapies have also evolved, either to manage these infants' respiratory distress syndrome with an aim to prevent BPD or to manage the established condition. Although there is good evidence to support the 'routine' use of some therapies, many other therapies currently used in relation to BPD remain individual- or institution-specific, depending on beliefs and myths that we have adopted. In this article, we discuss the importance of defining BPD more objectively and the support – or lack thereof – for the drug therapies used in relation to BPD.