Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

June 30, 2009 updated by: University of Padova

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 3 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.
Time Frame: Admission to the NICU
Admission to the NICU

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: NICU discharge
NICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Principal Investigator: Daniele Trevisanuto, MD, Azienda Ospedaliera of Padua

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

July 2, 2009

Last Update Submitted That Met QC Criteria

June 30, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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