Phototherapy is assumed to be both effective and safe for extremely low-birth-weight infants. Our objective was to critically assess the relevant evidence from randomized trials. In the decades-old Collaborative Phototherapy Trial, phototherapy reduced serum bilirubin but not neurodevelopmental impairments. In the recent and larger Neonatal Network Trial, aggressive phototherapy compared to conservative phototherapy reduced both peak serum bilirubin (7.0 vs. 9.8mg/dL) and profound impairment at 18-22 months adjusted age (relative risk = 0.68). However, both trials suggested that phototherapy increased deaths among the smallest infants. Conservative Bayesian analyses of ventilator-treated infants under 751g birth weight in the Network trial identified a 99% probability of increased deaths and 99% probability of reduced profound impairment with aggressive phototherapy. Potential strategies to optimize the risk/benefit ratio in achieving low serum bilirubin levels, e.g., use of lowered irradiance levels, light-emitting diode phototherapy units, cycled phototherapy, and/or porphyrin compounds, deserve rigorous evaluation.
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.
This review is presented in three segments: (1) important background concepts, (2) recent reports from regional geographically defined cohorts, and (3) prognosis research from the National Institutes of Health Neonatal Research Network. Extending the use of intensive care to newborns of lower gestational ages will unavoidably result in a higher proportion and a higher absolute number of survivors with morbidity, unless other changes in practice offset the increased risk associated with decreasing gestational age. In geographically defined cohort studies, the proportion of periviable newborns delivered in perinatal centers and the practices around foregoing and withdrawing intensive care are two important determinants of outcomes following periviable birth. It is much easier to quantify the effect of the former than the latter. Decisions regarding comfort care vs. intensive are frequently based on gestational age as the sole predictor variable, although multiple factors can be readily used to more accurately assess the benefits and burdens of intensive care and facilitate better informed parental counseling and decision making.
Our primary objective was to compare parents of infants cared for in newborn intensive care units (NICUs) and infants cared for in well-baby ("general") nurseries with regard to knowledge and practice of safe sleep practices/sudden infant death syndrome risk reduction measures and guidelines. Our secondary objective was to obtain qualitative data regarding reasons for noncompliance in both populations. Sixty participants (30 from each population) completed our survey measuring safe sleep knowledge and practice. Parents of NICU infants reported using 2 safe sleep practices-(a) always placing baby in crib to sleep and (b) always placing baby on back to sleep-significantly more frequently than parents of well infants. Additional findings and implications for future studies are discussed.
: Erythropoietin-stimulating agent (ESA) use is associated with serious adverse events in patients with hemoglobin levels of 12 g/dL or higher at the time of administration. Our aim was to determine whether inappropriate ESA use has changed over time since the implementation of new drug warning alerts and local quality improvement initiatives.
Objective: Sound levels, staff perceptions, and patient outcomes were evaluated during a year-long hospital renovation project on the floor above a neonatal intensive care unit (NICU).Background: Construction noise may be detrimental to NICU patients and healthcare professionals. There are no comprehensive studies evaluating the impact of hospital construction on sound levels, staff, and patients.Methods: Prospective observational study comparing sound measures and patient outcomes before, during, and after construction. Staff were surveyed about the construction noise, and hospital employee satisfaction scores are reported.Results: Equivalent sound levels were not significantly higher during construction. Most staff members (89%) perceived the renovation period as louder, and 83% reported interruptions of their work. Patient outcomes were the same or more positive during construction. Very low birth weight (VLBW) infants were less likely to require 24+ hours mechanical ventilation during construction: 54% vs. 59% before (OR = 1.6, p = 0.018) and 62% after (OR = 1.48, p = 0.065); and they required a shorter total period of mechanical ventilation: 3.6 days vs. 8.0 before (p = 0.011) and 9.5 after (p = 0.001). VLBW newborns differences in ventilation days were mostly in the upper extremes; medians were similar in all periods: 0.6 days vs. 1 day preconstruction and 2 days postconstruction.Conclusions: Construction above the NICU did not cause substantially louder sound levels, but staff perceived important changes in noise and work routines. No evidence suggested that patients were negatively affected by the renovation period. Meticulous construction planning remains necessary to avoid interference with patient care and caregiver work environments.
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