Pediatrics
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial.
Although earlier studies have suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent chronic lung disease in the extremely low birth weight (ELBW) infant, the time of initiation of CPAP has varied, and there are no prospective studies of infants who have received CPAP or positive end-expiratory pressure (PEEP) from initial resuscitation in the delivery room (DR). Current practice for the ELBW infant includes early intubation and the administration of prophylactic surfactant, often in the DR. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant has never been determined prospectively in a population of ELBW infants. This study was designed to determine the feasibility of randomizing ELBW infants of <28 weeks' gestation to CPAP/PEEP or no CPAP/PEEP during resuscitation immediately after delivery, avoiding routine DR intubation for surfactant administration, initiating CPAP on neonatal intensive care unit (NICU) admission, and assessing compliance with subsequent intubation criteria. ⋯ This study demonstrated that infants could be randomized successfully to a DR intervention of CPAP/PEEP compared with no CPAP/PEEP, with intubation provided only for resuscitation indications, and subsequent intubation for prespecified criteria. Forty-five percent (47 of 104) of infants <28 weeks' gestation required intubation for resuscitation in the DR. CPAP/PEEP in the DR did not affect the need for intubation at birth or during the subsequent week. Overall, 20% of infants did not need intubation by 7 days of life. This experience should be helpful in facilitating the design of subsequent prospective studies of ventilatory support in ELBW infants.
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Randomized Controlled Trial Clinical Trial
Hawaii's healthy start home visiting program: determinants and impact of rapid repeat birth.
Healthy People 2010 calls for reductions in rapid repeat births (RRBs), defined as births occurring within 24 months after a previous birth for women of all ages, and prevention of repeat births during adolescence, regardless of the birth interval. Home visiting has been promoted as a mechanism to prevent child abuse and neglect and to improve pregnancy outcomes. This study aims to assess the impact of home visiting in preventing RRB and its malleable determinants and assesses the influence of RRB on the mother and the index child. We hypothesized that maternal desire to have a RRB, access to a family planning site, and use of birth control would be significant malleable determinants and that the effects of the program in preventing RRB would be mediated through its influence on these variables. We also hypothesized that the occurrence of RRB would result in increased stress and family dysfunction, resulting in adverse maternal and child outcomes such as severe maternal stress, maternal neglect of the index child, decreased maternal warmth toward the index child, and increased behavior problems of the index child. ⋯ Overall, 20% of the mothers in our sample of at-risk families had a RRB, which was far greater than the national average of 11%. RRB was associated with a greater likelihood of adverse consequences for both the mother and the index child. The lack of program effects can be traced to shortcomings in the program's design and implementation system. HSP contracts required only that family planning be introduced any time during a family's first year of enrollment. Because conception can occur very soon after the index birth, a better design would be to introduce family planning counseling early in a family's enrollment in home visiting. Another shortcoming was that, although fathers could be included in counseling, they took part in only approximately one-fifth of home visits. It is possible that program effects were attenuated in families in which the father wanted a child. In conclusion, the Hawaii HSP did not reduce RRB or alter its malleable determinants. RRB was associated with adverse outcomes for both the mother and the index child. This is particularly relevant for this population of families that are already at risk for child maltreatment, for which we have found parenting stress to be associated with abusive parenting behavior by the mother. Our findings support and broaden the rationale for the Healthy People 2010 objective to reduce RRB. We think our findings are valuable for guiding the future development of home visiting in general and this widely replicated paraprofessional model in particular.
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The issue of thimerosal-containing vaccines as a possible cause of autistic spectrum disorders (ASD) and neurodevelopmental disorders (NDDs) has been a controversial topic since 1999. Although most practitioners are familiar with the controversy, many are not familiar with the type or quality of evidence in published articles that have addressed this issue. To assess the quality of evidence assessing a potential association between thimerosal-containing vaccines and autism and evaluate whether that evidence suggests accepting or rejecting the hypothesis, we systematically reviewed published articles that report original data pertinent to the potential association between thimerosal-containing vaccines and ASD/NDDs. ⋯ Studies do not demonstrate a link between thimerosal-containing vaccines and ASD, and the pharmacokinetics of ethylmercury make such an association less likely. Epidemiologic studies that support a link demonstrated significant design flaws that invalidate their conclusions. Evidence does not support a change in the standard of practice with regard to administration of thimerosal-containing vaccines in areas of the world where they are used.
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When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only after a community consultation and public disclosure process and the granting of exception from informed consent from the federal government. The applicability of exception from informed consent to pediatric resuscitation research has not been described. The objectives of this study were 1) to perform a community consultation and public disclosure process specific to a trial of induced hypothermia immediately after pediatric cardiac arrest and 2) to determine the applicability of exception from informed consent to randomized, controlled trials of emergency interventions after resuscitation from inpatient pediatric cardiac arrest. ⋯ Community consultation for inpatient resuscitation research can be conducted in a children's hospital, with hospital staff and parents of patients as the relevant community. Exception from informed consent is necessary and appropriate for a randomized trial of induced hypothermia begun within 30 minutes after pediatric cardiac arrest. A process in which families are informed prospectively and have a pre-enrollment option to decline participation will likely be acceptable to families, health care providers, and the institution.