Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
Primary Purpose
Hypothermia, Preterm Infants
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Polyethylene cap
Polyethylene wrap
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia, Preterm Infants focused on measuring delivery room, polyethylene cap, preterm infant, temperature
Eligibility Criteria
Inclusion Criteria:
- infants <29 weeks' gestation born in the study center.
Exclusion Criteria:
- congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
cap
wrap
conventional group
Arm Description
In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
Outcomes
Primary Outcome Measures
Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.
Secondary Outcome Measures
Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00930917
Brief Title
Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
Official Title
Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Padova
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss.
We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.
Detailed Description
The primary outcome measure was axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature less then 36.4°C, on NICU admission was also evaluated.
Secondary outcomes included mortality prior to hospital discharge, presence of major brain injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation, parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Preterm Infants
Keywords
delivery room, polyethylene cap, preterm infant, temperature
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cap
Arm Type
Experimental
Arm Description
In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
Arm Title
wrap
Arm Type
Active Comparator
Arm Description
Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
Arm Title
conventional group
Arm Type
Other
Arm Description
Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
Intervention Type
Device
Intervention Name(s)
Polyethylene cap
Intervention Description
In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
Intervention Type
Device
Intervention Name(s)
Polyethylene wrap
Intervention Description
Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
Primary Outcome Measure Information:
Title
Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.
Time Frame
Admission to the NICU
Secondary Outcome Measure Information:
Title
Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
Time Frame
NICU discharge
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:
infants <29 weeks' gestation born in the study center.
Exclusion Criteria:
congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Trevisanuto, MD
Organizational Affiliation
Azienda Ospedaliera of Padua
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
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
derived
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Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
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