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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

This study is currently recruiting participants.
Verified August 2012 by University of Padova
Sponsor:
Information provided by (Responsible Party):
University of Padova
ClinicalTrials.gov Identifier:
NCT01671241
First received: July 17, 2012
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypothermia
Preterm Infant
 Device: Polyethylene wrap
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Padova:

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

Secondary Outcome Measures:
  • Mortality prior to hospital discharge [ Designated as safety issue: Yes ]
  • Major brain injury [ Designated as safety issue: Yes ]
  • percentages of hyperthermic infants at NICU admission [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2011
Arms Assigned Interventions
Experimental: Total body polyethylene wrap (body plus head)
The entire body surface (body plus head) is covered by a polyethylene wrap
 Device: Polyethylene wrap
Active Comparator: Polyethylene wrap (body)
A polyethylene wrap covers the patient's body up to the neck
 Device: Polyethylene wrap

  Eligibility

Ages Eligible for Study:   up to 3 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671241

Locations
Italy
University of Padua, Azienda Ospedaliera di Padova Recruiting
Padua, Italy, 35128
Contact: Daniele Trevisanuto, MD     39 049 8213545     trevo@pediatria.unipd.it    
Principal Investigator: Daniele Trevisanuto, MD            
Sponsors and Collaborators
University of Padova
  More Information

Publications:

Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01671241     History of Changes
Other Study ID Numbers: LossPreventionTotalBodyWrap
Study First Received: July 17, 2012
Last Updated: August 22, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013