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

University of Padova

Status and phase: Unknown; Phase 3

Conditions: Preterm Infant; Hypothermia

Treatments: Device: Polyethylene wrap

Study type: Interventional

Funder types: Other

Identifiers

NCT01671241

LossPreventionTotalBodyWrap

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 3 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Total body polyethylene wrap (body plus head)

Experimental group

Description:

The entire body surface (body plus head) is covered by a polyethylene wrap

Treatment:

Device: Polyethylene wrap

Device: Polyethylene wrap

Polyethylene wrap (body)

Active Comparator group

Description:

A polyethylene wrap covers the patient's body up to the neck

Treatment:

Device: Polyethylene wrap

Device: Polyethylene wrap