Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930917
• Other study ID #: NIDA8
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2009
• Last updated: June 30, 2009
• Start date: December 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Minutes

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Preterm Infants

Intervention

Device:
• Polyethylene cap
In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
• 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.

Other:
• conventional treatment
Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.		Admission to the NICU	Yes
Secondary	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	Yes