Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping

Phase 3

• Conditions: Hypothermia; Preterm Infant
• Interventions: Device: Polyethylene wrap

• Registration Number: NCT01671241
• Lead Sponsor: University of Padova

Brief Summary

Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the proportions of hypothermic infants at NICU admission (temperature \<34°C) in the wrapped group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The combination of body and head protection with a polyethylene wrap needs to be evaluated further. The investigators conducted a prospective, randomized, controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping (body plus head) prevents heat loss after delivery better than polyethylene occlusive wrapping.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-07-17
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-22
• Last Update Submitted: 2012-08-22
• Study First Posted: 2012-08-23
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Preterm infants <29 weeks' gestation born in the study centers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total body polyethylene wrap (body plus head)	Polyethylene wrap	The entire body surface (body plus head) is covered by a polyethylene wrap
Polyethylene wrap (body)	Polyethylene wrap	A polyethylene wrap covers the patient's body up to the neck

Primary Outcome Measures

Name	Time	Method
Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later

Secondary Outcome Measures

Name	Time	Method
Mortality prior to hospital discharge
Major brain injury
percentages of hyperthermic infants at NICU admission

Trial Locations

Locations (1)

University of Padua, Azienda Ospedaliera di Padova; 🇮🇹 Padua, Italy