SLIGHT shield dataset on effect of chest shielding during phototherapy in premature infants on the incidence of patent ductus arteriosus
Amin, Sanjiv ; Mannan, Javed
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Abstract
The SLIGHT shield dataset reflects the results from a double blind randomized trial on the effect of chest shielding during phototherapy in premature infants on the incidence of patent ductus arteriosus. All preterm infants ≤ 29 weeks GA or weighing ≤1000 grams at birth admitted to our neonatal intensive care unit (NICU) within the first 24 hours of life were eligible for the study and randomized to chest shield placement or sham shield placement during phototherapy treatment. Enrollment occurred from August 1, 2015 to April 13, 2018. The primary outcome was the incidence of sPDA diagnosed via clinical parameters by the investigator team during the period from 24 hours after initiating phototherapy to 3 days after stopping phototherapy. Secondary outcomes consistent of echo based parameters : 1) ductal diameter with a left to right or bidirectional shunt across the PDA 2) left atrium (LA) to aortic root (AO) diameter ratio (LA/AO) and 3) LA volume. Additional secondary outcomes included the following: 1) surgical ligation of PDA, 2) chronic lung disease (CLD), 3) retinopathy of prematurity (ROP), 4) intraventricular hemorrhage (IVH), 5) peak levels of total serum bilirubin and 6) duration of phototherapy. Baseline/demographc data as well as clinical data were also obtained. Study participants self-reported three items assessing religiosity: strength/comfort from religion, petition prayers for health, and awareness of intercessory prayers by others. All cause-mortality within 2-years of hospital discharge was ascertained by review of medical records at participating study hospitals and from death certificates. Cox proportional hazards models were used to estimate the multivariable adjusted risk of 2-year all-cause mortality.