Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

NCT00930917 | Completed Phase 3

• 1 other identifier: NIDA8
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypothermia, Preterm Infants

Keywords

delivery room, polyethylene cap, preterm infant, temperature

Outcome Measures

Primary Outcomes (1)

• Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.

  Admission to the NICU

Secondary Outcomes (1)

• 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

Study Arms (3)

cap

EXPERIMENTAL

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

Device: Polyethylene cap

wrap

ACTIVE COMPARATOR

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

conventional group

OTHER

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

Other: conventional treatment

Interventions

Polyethylene cap DEVICE

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

cap

Polyethylene wrap DEVICE

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

wrap

conventional treatment OTHER

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

conventional group

Eligibility Criteria

• Age: 1 Minute - 3 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants \<29 weeks' gestation born in the study center.

You may not qualify if:

• congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.

Sponsors & Collaborators

• University of Padova: lead

Related Publications (1)

• 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.

  PMID: 20227728 DERIVED

MeSH Terms

Conditions

Hypothermia; Premature Birth

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Daniele Trevisanuto, MD

  Azienda Ospedaliera of Padua

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 2, 2009
• Study Start: December 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 2, 2009

Record last verified: 2009-06