Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

University of Padova

Status and phase: Completed; Phase 3

Conditions: Hypothermia, Preterm Infants

Treatments: Device: Polyethylene cap; Device: Polyethylene wrap; Other: conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00930917

NIDA8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 1 to 3 minutes old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

cap

Experimental group

Description:

In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth

Treatment:

Device: Polyethylene cap

wrap

Active Comparator group

Description:

Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.

Treatment:

Device: Polyethylene wrap

conventional group

Other group

Description:

Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.

Treatment:

Other: conventional treatment