Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

Official Title: “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.

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 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.
• Other: conventional group
  • Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 3 Minutes

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Padova Other

Overall Clinical Trial Officials and Contacts

Daniele Trevisanuto, MD Principal Investigator Azienda Ospedaliera of Padua  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930917

Study ID Number: NIDA8

ClinicalTrials.gov Identifier: NCT00930917

Health Authority: Italy: Ethics Committee