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Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
American Academy of Pediatrics
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: February 27, 2009
Last updated: June 24, 2010
Last verified: June 2010
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.

Condition Intervention
Other: Plastic Lined Stockinette hat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Effectiveness of Plastic Lined Hats for Prevention of Hypothermia in Premature Newborns in the Delivery Room

Resource links provided by NLM:

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Hypothermia (rectal temperature of < 36.5) [ Time Frame: 1 hour ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 1 year ]
  • Infection [ Time Frame: 1 year ]
  • Necrotizing enterocolitis [ Time Frame: 1 year ]
  • Intraventricular Hemorrhage [ Time Frame: 1 year ]
  • Bronchopulmonary Dysplasia [ Time Frame: 1 year ]
  • Days on Ventilator [ Time Frame: 1 year ]
  • Length of hospital stay [ Time Frame: 1 year ]

Estimated Enrollment: 260
Study Start Date: September 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Plastic Lined Stockinette hat
    hat made of unbleached 100% cotton stockinette that is lined with plastic (standard food sandwich bag)
    Other Names:
    • Polyethylene Plastic lined hats
    • stockinet caps
    • stockinette caps
    • occlusive wrap
  Show Detailed Description


Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00904228

Contact: Lucy H Christie, RN 214-590-0664

United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Lilian T StJohn, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
American Academy of Pediatrics
Principal Investigator: Lilian T StJohn, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Lilian St.John, MD; Post-Graduate Fellow in Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center Identifier: NCT00904228     History of Changes
Other Study ID Numbers: 052008-049
Study First Received: February 27, 2009
Last Updated: June 24, 2010

Keywords provided by University of Texas Southwestern Medical Center:
bronchopulmonary dysplasia
intraventricular hemorrhage
ventilator days

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms processed this record on May 25, 2017