Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping
Primary Purpose
Hypothermia, Preterm Infant
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Polyethylene wrap
Polyethylene wrap
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia
Eligibility 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
Sites / Locations
- University of Padua, Azienda Ospedaliera di PadovaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Total body polyethylene wrap (body plus head)
Polyethylene wrap (body)
Arm Description
The entire body surface (body plus head) is covered by a polyethylene wrap
A polyethylene wrap covers the patient's body up to the neck
Outcomes
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
Major brain injury
percentages of hyperthermic infants at NICU admission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01671241
Brief Title
Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Preterm Infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total body polyethylene wrap (body plus head)
Arm Type
Experimental
Arm Description
The entire body surface (body plus head) is covered by a polyethylene wrap
Arm Title
Polyethylene wrap (body)
Arm Type
Active Comparator
Arm Description
A polyethylene wrap covers the patient's body up to the neck
Intervention Type
Device
Intervention Name(s)
Polyethylene wrap
Intervention Type
Device
Intervention Name(s)
Polyethylene wrap
Primary Outcome Measure Information:
Title
Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later
Secondary Outcome Measure Information:
Title
Mortality prior to hospital discharge
Title
Major brain injury
Title
percentages of hyperthermic infants at NICU admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
3 Minutes
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Padua, Azienda Ospedaliera di Padova
City
Padua
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Trevisanuto, MD
Phone
39 049 8213545
Email
trevo@pediatria.unipd.it
First Name & Middle Initial & Last Name & Degree
Daniele Trevisanuto, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15580195
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. doi: 10.1016/j.jpeds.2004.07.036.
Results Reference
background
PubMed Identifier
10228287
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. doi: 10.1016/s0022-3476(99)70238-6.
Results Reference
background
PubMed Identifier
20227728
Citation
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.
Results Reference
background
PubMed Identifier
24837862
Citation
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.
Results Reference
derived
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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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