Hypothermia, Preterm Infants Clinical Trial
Official title:
Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants
It is apparent that the head of a preterm infant should not be left uncovered, however it
remains unclear whether covering the head of a preterm baby with plastic wrapping is
effective in preventing heat loss.
We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate
if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive
wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after
admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap
prevents postnatal heat loss.
The primary outcome measure was axillary temperature taken on admission to the NICU
(immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was
measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo
Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature
less then 36.4°C, on NICU admission was also evaluated.
Secondary outcomes included mortality prior to hospital discharge, presence of major brain
injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation,
parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at
birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose
concentration on NICU admission.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment