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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

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ClinicalTrials.gov Identifier: NCT01671241
Recruitment Status : Unknown
Verified August 2012 by University of Padova.
Recruitment status was:  Recruiting
First Posted : August 23, 2012
Last Update Posted : August 23, 2012
Sponsor:
Information provided by (Responsible Party):
University of Padova

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.

Condition or disease Intervention/treatment Phase
Hypothermia Preterm Infant Device: Polyethylene wrap Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. Mortality prior to hospital discharge
  2. Major brain injury
  3. percentages of hyperthermic infants at NICU admission


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Minutes   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01671241     History of Changes
Other Study ID Numbers: LossPreventionTotalBodyWrap
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Premature Birth
Hypothermia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Body Temperature Changes
Signs and Symptoms