Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothermia, Preterm Infants

Intervention / Treatment
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* Device: Polyethylene cap
* Device: Polyethylene wrap
* Other: conventional treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 3 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cap<br>In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth | Device: Polyethylene cap<br>* In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth<br>|
| Active Comparator: wrap<br>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<br>* Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.<br>|
| Other: conventional group<br>Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation. | Other: conventional treatment<br>* Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delivery room, polyethylene cap, preterm infant, temperature