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

Completed · Not applicable

Conditions studied: Hypothermia

In brief

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.

Key facts

Study ID: NCT00904228
Run by: University of Texas Southwestern Medical Center
People needed: 260
Starts: 2008-09-01
Expected to finish: 2010-12-01
Last updated by the study team: 2019-04-25

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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