Dataset Information

Timing for the Introduction of Cycled Light for Extremely Preterm Infants: A Randomized Controlled Trial.

ABSTRACT: Day-night cycled light improves health outcomes in preterm infants, yet the best time to institute cycled light is unclear. The hypothesis of this study was that extremely preterm infants receiving early cycled light would have better health and developmental outcomes than infants receiving late cycled light. Infants born at ?28 weeks gestation were randomly assigned to early cycled light (ECL) starting at 28 weeks postmenstrual age [PMA] or late cycled light (LCL), starting at 36 weeks PMA. Daylight was 200-600 lux and night was 5-30 lux. Primary outcomes were weight over time and length of hospitalization. Secondary outcomes were hospital costs, sleep development, and neurodevelopment at 9, 18, and 24 months corrected age. Of 121 infants randomized, 118 were included in analysis. Weight gain in the two groups did not differ significantly but increased across time in both groups. In PMA weeks 36-44, the mean weight gain was 193.8 grams in the ECL group compared to 176.3 grams in the LCL group. Effect sizes for weight were Cohen d?=?0.26 and 0.36 for 36 and 44 weeks PMA. Infants in the ECL group went home an average of 5.5 days earlier than the LCL group, but this difference was not statistically significant. There were no group differences on neurodevelopmental outcomes. Although statistically non-significant, clinically important differences of improved weight gain and decreased hospital stay were observed with ECL. The small observed effect sizes on weight during hospitalization should be considered in future cycled light research with extremely preterm infants. © 2017 Wiley Periodicals, Inc.

SUBMITTER: Brandon DH

PROVIDER: S-EPMC5522348 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Timing for the Introduction of Cycled Light for Extremely Preterm Infants: A Randomized Controlled Trial.

Brandon Debra H DH Silva Susan G SG Park Jinhee J Malcolm William W Kamhawy Heba H Holditch-Davis Diane D

Research in nursing & health 20170421 4

Day-night cycled light improves health outcomes in preterm infants, yet the best time to institute cycled light is unclear. The hypothesis of this study was that extremely preterm infants receiving early cycled light would have better health and developmental outcomes than infants receiving late cycled light. Infants born at ≤28 weeks gestation were randomly assigned to early cycled light (ECL) starting at 28 weeks postmenstrual age [PMA] or late cycled light (LCL), starting at 36 weeks PMA. Day ...[more]

PMID: 28431191

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Project description:ImportanceCycled (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).ObjectiveTo 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 participantsThis 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.InterventionsTwo 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 measuresMean 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.ResultsConsent was requested for 452 eligible infants and obtained for 305 (all enrolled) (mean [SD] birth weight, 749 [152] 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 relevanceCycled 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 registrationClinicalTrials.gov Identifier: NCT01944696.

Project description:BackgroundDue to insufficient evidence, extremely preterm infants (≤28 wk of gestation) rarely receive early progressive feeding (small increments of feeding volumes between 1 and 4 d after birth). We hypothesized that early progressive feeding increases the number of full enteral feeding days in the first month after birth.ObjectiveThe aim of this study was to determine the feasibility and efficacy of early progressive feeding in extremely preterm infants.DesignIn this single-center randomized trial, extremely preterm infants born between September 2016 and June 2017 were randomly assigned to receive either early progressive feeding without trophic feeding (early feeding group) or delayed progressive feeding after a 4-d course of trophic feeding (delayed feeding group). Treatment allocation occurred before or on feeding day 1. The primary outcome was the number of full enteral feeding days in the first month after birth. Secondary outcomes were death, necrotizing enterocolitis (NEC), culture-proven sepsis, growth percentiles at 36 wk postmenstrual age, use of parenteral nutrition, and need for central venous access.ResultsSixty infants were included (median gestational age: 26 wk; mean ± SD birth weight: 832 ± 253 g). The primary outcome differed between groups (median difference favoring the early feeding group: +2 d; 95% CI: 0, 3 d; P = 0.02). Early progressive feeding reduced the use of parenteral nutrition (4 compared with 8 d; P ≤ 0.01) and the need for central venous access (9 compared with 13 d; P ≤ 0.01). The outcome of culture-proven sepsis (10% compared with 27%; P = 0.18), restricted growth (weight, length, and head circumference <10th percentile) at 36 wk postmenstrual age (25% compared with 50%; P = 0.07), and the composite outcome of NEC or death (27% compared with 20%; P = 0.74) did not differ between groups.ConclusionEarly progressive feeding increases the number of full enteral feeding days in extremely preterm infants. This trial was registered at www.clinicaltrials.gov as NCT02915549.

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Dataset Information

Timing for the Introduction of Cycled Light for Extremely Preterm Infants: A Randomized Controlled Trial.

Publications

Timing for the Introduction of Cycled Light for Extremely Preterm Infants: A Randomized Controlled Trial.

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