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Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

NCT00930917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2009-07-02

No results posted yet for this study

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.

Conditions

  • Hypothermia, Preterm Infants

Interventions

DEVICE

Polyethylene cap

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

DEVICE

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.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Daniele Trevisanuto, MD · Azienda Ospedaliera of Padua

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
1 Minute
Max Age
3 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930917 on ClinicalTrials.gov