Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

Phase 3

Completed

• Conditions: Hypothermia, Preterm Infants
• Interventions: Device: Polyethylene cap; Device: Polyethylene wrap; Other: conventional treatment

• Registration Number: NCT00930917
• Lead Sponsor: University of Padova

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-06
• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-06-30
• Last Update Submitted: 2009-06-30
• Study First Posted: 2009-07-02
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• infants <29 weeks' gestation born in the study center.

Exclusion Criteria

• congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
cap	Polyethylene cap	In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
wrap	Polyethylene wrap	Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
conventional group	conventional treatment	Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.

Primary Outcome Measures

Name	Time	Method
Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.	Admission to the NICU

Secondary Outcome Measures

Name	Time	Method
Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.	NICU discharge