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Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00930917
Enrollment
96
Registered
2009-07-02
Start date
2007-12-31
Completion date
2009-02-28
Last updated
2009-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Preterm Infants

Keywords

delivery room, polyethylene cap, preterm infant, temperature

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.

Interventions

DEVICEPolyethylene cap

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

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

OTHERconventional treatment

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

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 3 Minutes
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime 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.NICU discharge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026