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

NCT ID: NCT01671241

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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

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Conditions

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Hypothermia Preterm Infant

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Total body polyethylene wrap (body plus head)

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

Group Type EXPERIMENTAL

Polyethylene wrap

Intervention Type DEVICE

Polyethylene wrap (body)

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

Group Type ACTIVE_COMPARATOR

Polyethylene wrap

Intervention Type DEVICE

Interventions

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Polyethylene wrap

Intervention Type DEVICE

Polyethylene wrap

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

3 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Padua, Azienda Ospedaliera di Padova

Padua, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Daniele Trevisanuto, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15580195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10228287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20227728 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24837862 (View on PubMed)

Other Identifiers

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LossPreventionTotalBodyWrap

Identifier Type: -

Identifier Source: org_study_id