Dataset Information

Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial.

ABSTRACT:

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 [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 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.

SUBMITTER: Arnold C

PROVIDER: S-EPMC7186919 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Introduction Previous studies have explored factors that influence the occurrence of hypothermia in very low/extremely low birth weight (VLBW/ELBW) infants, but the factors associated with hypothermia in VLBW or ELBW infants remain inadequately evaluated due to limited prospective data and inconsistency in study populations. Therefore, it is necessary to systematically evaluate the risk factors of hypothermia in VLBW/ELBW infants in order to provide a theoretical basis for clinical practice. Methods PubMed and other databases were used to search for case-control or cohort studies on factors influencing the occurrence of hypothermia in VLBW/ELBW infants. The search time was set from database creation to June 30th, 2022. Literature screening, quality evaluation, and data extraction were performed independently by two investigators according to predefined inclusion and exclusion criteria. Meta-analysis was performed using RevMan 5.3. Results A total of 10 papers were finally included in this study and 12 factors were established by meta-analysis: body weight (six papers), failure to keep warm in time (three papers), neonatal resuscitation (seven papers), gestational age (three papers), premature rupture of membranes (three papers), maternal combined complications (four papers), cesarean section (six papers), antenatal steroids (four papers), multiple birth (two papers), small for gestational age (two papers), 1 min Apgar score (three papers), and 5 min Apgar score (three papers). Since only one study included race, age (hour), socio-economic status, and spontaneous labor, these factors could not be fitted into RevMan 5.3 for the analysis. Conclusion Although there were differences in the study design of the included literature, the influencing factors described in each study were relatively similar. The influencing factors identified in this study may contribute to the construction of related intervention strategies for hypothermia in VLBW/ELBW infants.