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

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ClinicalTrials.gov Identifier: NCT00904228
Recruitment Status : Unknown
Verified June 2010 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : May 19, 2009
Last Update Posted : June 28, 2010
Sponsor:
Collaborator:
American Academy of Pediatrics
Information provided by:
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Hypothermia Other: Plastic Lined Stockinette hat Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effectiveness of Plastic Lined Hats for Prevention of Hypothermia in Premature Newborns in the Delivery Room
Study Start Date : September 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources


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


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

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
  2. Infection [ Time Frame: 1 year ]
  3. Necrotizing enterocolitis [ Time Frame: 1 year ]
  4. Intraventricular Hemorrhage [ Time Frame: 1 year ]
  5. Bronchopulmonary Dysplasia [ Time Frame: 1 year ]
  6. Days on Ventilator [ Time Frame: 1 year ]
  7. Length of hospital stay [ Time Frame: 1 year ]


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Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010

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