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

Hypothermia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01671241
• Other study ID #: LossPreventionTotalBodyWrap
• Status: Recruiting
• Phase: Phase 3
• First received: July 17, 2012
• Last updated: August 22, 2012
• Start date: January 2011

Study information

• Verified date: August 2012
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Minutes

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Preterm Infant

Intervention

Device:
• Polyethylene wrap

• Polyethylene wrap

Locations

Country	Name	City	State
Italy	University of Padua, Azienda Ospedaliera di Padova	Padua

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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):914-7, 917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later
Secondary	Mortality prior to hospital discharge			Yes
Secondary	Major brain injury			Yes
Secondary	percentages of hyperthermic infants at NICU admission			Yes