Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
Effectiveness of Plastic Lined Hats for Prevention of Hypothermia in Premature Newborns in the Delivery Room
1 other identifier
interventional
260
1 country
1
Brief Summary
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature \<36.5º Celsius by the World Health Organization. The surface area of the head is about 20% of total body surface of a newborn infant and is a major source of heat loss. The objective is to compare rectal temperature upon admission to the neonatal intensive care between preterm neonates who had stockinet head covering and those who had plastic-lined stockinet head covering placed in the delivery room. The investigators aim to demonstrate that plastic-lined head covering is more effective than stockinet head covering alone in maintaining body temperature.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 27, 2009
CompletedFirst Posted
Study publicly available on registry
May 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 25, 2019
April 1, 2019
2 years
February 27, 2009
April 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypothermia
admission rectal temperature \<36.5C
1 hour
Secondary Outcomes (7)
Mortality
1 year
Infection
1 year
Necrotizing enterocolitis
1 year
Intraventricular Hemorrhage
1 year
Bronchopulmonary Dysplasia
1 year
- +2 more secondary outcomes
Study Arms (2)
Plastic Cap
EXPERIMENTALPlastic lined stockinet cap (polyethylene bag)
Stockinet Cap
ACTIVE COMPARATORUsual practice
Interventions
placement of plastic cap during delivery room stabilization
Eligibility Criteria
You may qualify if:
- Infants with less than 33 week gestational age by obstetrical dating
- Infants delivered in Parkland Memorial Hospital Labor and Delivery areas
- Infant whose delivery was attended by the Parkland Neonatal Resuscitation Team
- Infant whos is viable
You may not qualify if:
- Infant who has 33 week gestational age or greater by obstetrical dating
- Infant who is deemed non-viable
- Infant who did not have the Parkland Neonatal Resuscitation Team present at time of birth
- Infant with congenital anomaly which precludes measurement of rectal temperature (such as anal atresia or imperforate anus)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parkland Memorial Hospital
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lilian T StJohn, MD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 27, 2009
First Posted
May 19, 2009
Study Start
September 1, 2008
Primary Completion
September 1, 2010
Study Completion
December 1, 2010
Last Updated
April 25, 2019
Record last verified: 2019-04