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Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

This study has been completed.
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00930917
First received: June 30, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hypothermia, Preterm Infants
 Device: Polyethylene cap
Device: Polyethylene wrap
Other: conventional treatment
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Padova:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 96
Study Start Date: December 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   up to 3 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930917

Sponsors and Collaborators
University of Padova
Investigators
Principal Investigator: Daniele Trevisanuto, MD Azienda Ospedaliera of Padua
  More Information

No publications provided by University of Padova

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daniele Trevisanuto, Azienda Ospedaliera of Padua
ClinicalTrials.gov Identifier: NCT00930917     History of Changes
Other Study ID Numbers: NIDA8
Study First Received: June 30, 2009
Last Updated: June 30, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Padova:
delivery room, polyethylene cap, preterm infant, temperature

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013