Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial.
Phototherapy and the Risk of Photo-Oxidative Injury in Extremely Low Birth Weight Infants
CLINICS IN PERINATOLOGY
2016; 43 (2): 291-?
Importance: Cycled (intermittent) phototherapy (PT) might adequately control peak total serum bilirubin (TSB) level and avoid mortality associated with usual care (continuous PT) among extremely low-birth-weight (ELBW) infants (401-1000 g).Objective: To identify a cycled PT regimen that substantially reduces PT exposure, with an increase in mean peak TSB level lower than 1.5 mg/dL in ELBW infants.Design, Setting, and Participants: This dose-finding randomized clinical trial of cycled PT vs continuous PT among 305 ELBW infants in 6 US newborn intensive care units was conducted from March 12, 2014, to November 14, 2018.Interventions: Two cycled PT regimens (?15 min/h and ?30 min/h) were provided using a simple, commercially available timer to titrate PT minutes per hour against TSB level. The comparator arm was usual care (continuous PT).Main Outcomes and Measures: Mean peak TSB level and total PT hours through day 14 in all 6 centers and predischarge brainstem auditory-evoked response wave V latency in 1 center. Mortality and major morbidities were secondary outcomes despite limited power.Results: Consent was requested for 452 eligible infants and obtained for 305 (all enrolled) (mean [SD] birth weight, 749  g; gestational age, 25.7 [1.9] weeks; 81 infants [27%] were multiple births; 137 infants [45%] were male; 112 [37%] were black infants; and 107 [35%] were Hispanic infants). Clinical and demographic characteristics of the groups were similar at baseline. After a preplanned interim analysis of 100 infants, the regimen of 30 min/h or more was discontinued, and the study proceeded with 2 arms. Comparing 128 infants receiving PT of 15 min/h or more with 128 infants receiving continuous PT among those surviving to 14 days, mean peak TSB levels were 7.1 vs 6.4 mg/dL (adjusted difference, 0.7; 95% CI, 0.4-1.1 mg/dL) and mean total PT hours were 34 vs 72 (adjusted difference, -39; 95% CI, -45 to -32). Wave V latency adjusted for postmenstrual age was similar in 37 infants receiving 15 min/h or more of PT and 33 infants receiving continuous PT: 7.42 vs 7.32 milliseconds (difference, 0.10; 95% CI, -0.11 to 0.30 millisecond). The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of -4.5% (95% CI, -10.9 to 2.0). Morbidities did not differ between groups.Conclusions and Relevance: Cycled PT can substantially reduce total PT with little increase in peak TSB level. A large, randomized trial is needed to assess whether cycled PT would increase survival and survival without impairment in small, preterm infants.Trial Registration: ClinicalTrials.gov Identifier: NCT01944696.
View details for DOI 10.1001/jamapediatrics.2020.0559
View details for PubMedID 32338720
Phototherapy in ELBW newborns: does it work? Is it safe? The evidence from randomized clinical trials.
Seminars in perinatology
2014; 38 (7): 452?64
Phototherapy has been used to treat newborns with jaundice for more than 50 years with the presumption that it is safe and effective for all infants. In fact, this presumption may not be true for all infants, especially the smallest and most immature. The safety and efficacy of phototherapy have never really been questioned or adequately tested in the latter, yet clinical applications of phototherapy have been further refined as its mechanisms of action have been better understood and alternative light sources have become available. This article addresses what is known about the possible risks of photo-oxidative injury in extremely low birth weight infants.
View details for DOI 10.1016/j.clp.2016.01.005
View details for PubMedID 27235208
Outcomes following periviable birth.
Seminars in perinatology
2014; 38 (1): 2?11
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.
View details for DOI 10.1053/j.semperi.2014.08.008
View details for PubMedID 25308614
Safe sleep practices and sudden infant death syndrome risk reduction: NICU and well-baby nursery graduates.
2013; 52 (11): 1044?53
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.
View details for DOI 10.1053/j.semperi.2013.07.002
View details for PubMedID 24468563
Variability in vancomycin use in newborn intensive care units determined from data in an electronic medical record.
Infection control and hospital epidemiology
2008; 29 (7): 667?70
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.
View details for DOI 10.1177/0009922813506038
View details for PubMedID 24137040
Data from an electronic medical record were used to demonstrate a large variation in the proportion of patients treated with vancomycin in 56 newborn intensive care units, which ranged from 18% to 70% . Use of oxacillin or nafcillin instead of vancomycin was rare during the first few years of the study period but was routine in 13% of the newborn intensive care units during the last few years of the study period. The use of electronic medical record data for studies of antibiotic use is discussed here.
View details for DOI 10.1086/588589
View details for PubMedID 18518667