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

NCT01671241 | Unknown Phase 3 DMC

• 1 other identifier: LossPreventionTotalBodyWrap
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Preterm Infant

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Mortality prior to hospital discharge

• Major brain injury

• percentages of hyperthermic infants at NICU admission

Study Arms (2)

Total body polyethylene wrap (body plus head)

EXPERIMENTAL

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

Device: Polyethylene wrap

Polyethylene wrap (body)

ACTIVE COMPARATOR

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

Device: Polyethylene wrap

Interventions

Polyethylene wrap DEVICE

Total body polyethylene wrap (body plus head)

Eligibility Criteria

• Age: 1 Minute - 3 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padua, Azienda Ospedaliera di Padova

Padua, 35128, Italy

RECRUITING

Related Publications (4)

• Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.

  PMID: 15580195 BACKGROUND

• Vohra S, Frent G, Campbell V, Abbott M, Whyte R. Effect of polyethylene occlusive skin wrapping on heat loss in very low birth weight infants at delivery: a randomized trial. J Pediatr. 1999 May;134(5):547-51. doi: 10.1016/s0022-3476(99)70238-6.

  PMID: 10228287 BACKGROUND

• Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.

  PMID: 20227728 BACKGROUND

• Doglioni N, Cavallin F, Mardegan V, Palatron S, Filippone M, Vecchiato L, Bellettato M, Chiandetti L, Trevisanuto D. Total body polyethylene wraps for preventing hypothermia in preterm infants: a randomized trial. J Pediatr. 2014 Aug;165(2):261-266.e1. doi: 10.1016/j.jpeds.2014.04.010. Epub 2014 May 14.

  PMID: 24837862 DERIVED

MeSH Terms

Conditions

Hypothermia; Premature Birth

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: August 23, 2012
• Study Start: January 1, 2011
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

IT (1)