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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 because the information has not been verified recently.
Verified June 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Academy of Pediatrics
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00904228
First received: February 27, 2009
Last updated: June 24, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Hypothermia
 Other: Plastic Lined Stockinette hat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Necrotizing enterocolitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intraventricular Hemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bronchopulmonary Dysplasia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Days on Ventilator [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   up to 1 Hour
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904228

Contacts
Contact: Lucy H Christie, RN 214-590-0664 lucy.christie@utsouthwestern.edu

Locations
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
Investigators
Principal Investigator: Lilian T StJohn, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

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

Keywords provided by University of Texas Southwestern Medical Center:
hypothermia
euthermia
hyperthermia
mortality
morbidity
 sepsis
bronchopulmonary dysplasia
intraventricular hemorrhage
ventilator days

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013