Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

NCT ID: NCT00930917

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-02-28

Brief 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.

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.

Conditions

Hypothermia, Preterm Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cap

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

Group Type: EXPERIMENTAL

Polyethylene cap

Intervention Type: DEVICE

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

wrap

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

Group Type: ACTIVE_COMPARATOR

Polyethylene wrap

Intervention Type: DEVICE

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.

Group Type: OTHER

conventional treatment

Intervention Type: OTHER

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

Interventions

Polyethylene cap

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

Intervention Type: 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.

Intervention Type: DEVICE

conventional treatment

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 3 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Azienda Ospedaliera of Padua

Principal Investigators

Daniele Trevisanuto, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera of Padua

References

Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.

Reference Type: DERIVED

PMID: 20227728 (View on PubMed)

Other Identifiers

NIDA8

Identifier Type: -

Identifier Source: org_study_id