View Clinical Trial (Medical Research Study)
Effectiveness of Plastic Lined Hats for Prevention of Hypothermia in Premature Newborns in the Delivery Room
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75390 |
| Conditions: |
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Hypothermia |
| Purpose: |
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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.
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| Study Summary: |
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A prospective randomized control trial will be conducted in Parkland Memorial Hospital (PMH)
neonatal intensive care unit (NICU) Dallas, Texas. Consent will not be obtained since:
placement of plastic and/or stockinet head covering on the neonate is part of routine
resuscitation care at PMH and by Neonatal Resuscitation Program (NRP) minimal risk to the
preterm neonate is involved, post-delivery consent will be of little value since
intervention only last ~24minutes, and obtaining informed consent from a mother who has
labor pains or is on pain medication may be difficult.
Randomization of the neonates will be carried out in the delivery room by opening a sealed,
opaque envelope just prior to birth. Qualified preterm newborns will be stratified into 2
OB EGA groups: (≤28weeks obstetrical(OB)estimated gestational age (EGA) and 29-32weeks OB
EGA. In each stratified group, the newborns will be further randomized to control arm
(stockinet head covering) or the intervention arm (plastic-lined head covering). Each arm
of the study will have a sample size of 65, allowing for 130 infants in each OB EGA
stratified group and for a sample size total of 260. Treatment versus control will be
assigned by blocks of 8 by using a random permutation table. The assignment will be sealed
in an opaque envelope by a non-participant person of the research.
The PMH high-risk resuscitation (RESUS) team attends all deliveries of infants ≤32 weeks OB
EGA. The RESUS team is comprised of a resuscitation nurse, a respiratory therapist, and a
practitioner. Neonatology fellow and/or attending may also attend these deliveries.
The use of warming aids by the RESUS team is standardized in the following manner:
Randomization envelope will be opened. All infants will be taken from the obstetrician by
the practitioner to an Ohio radiant warmer that has been pre-warmed to 100% capacity prior
to the delivery of the infant. A food-grade storage (polyethylene) bag (will be referred as
"poncho") will be used on all infants with the EGA of 32 weeks or less OB EGA to decrease
evaporative and convective heat loss. The poncho will be placed by cutting a hole at the
closed end of the bag for the purposes of inserting the head through it. The infants will
not be dried except for the face as recommended by NRP. All infants that are ≤28weeks OB
EGA will have a transwarmer mattress gel pad activated and placed on the radiant warmer
during resuscitation and during transport as per PMH NICU and NRP standard practice. The
appropriate head covering will then be placed to the level of the forehead on the infant as
per randomization assignment. If access to the infant's umbilical cord is needed, a hole
will be cut at the appropriate location. All infants will be transported in a dedicated
isolette for resuscitation that has been prewarmed to 38ºC. The warming aids will be in
place until the infant's arrival in the NICU.
The RESUS team will gather the following data in the delivery room: environmental
temperature of the delivery room, rectal temperature immediately after delivery, annotation
of warming aids implemented. The RESUS team also cares for the infant in the first 4 hours
of life. Initial vital signs (heart rate, respiratory rate, and blood pressure),
temperature, need of ventilation, need of intervention will be recorded by the RESUS team.
After 4 hours the care will be assumed by the primary NICU team as per our standard
practice.
Once the admission rectal temperature is taken, the head coverings will be removed and the
infant will no longer be actively enrolled in the research. The rest of the data will be
gathered through the Neonatal Resuscitation Database and Parkland NICU Morbidity and
Mortality Database.
The rationale of this study is that no randomized control trial has been done to demonstrate
the effectiveness of placement of plastic-lined head covering versus stockinet head
covering. It would seem logical that if measures are taken to decrease heat loss from the
head, these measures would improve temperature stability and avoid hypothermia in the
premature neonate.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00904228 |
| Primary Contact: |
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Principal Investigator
Lilian T StJohn, MD
University of Texas Southwestern Medical Center
Lucy H Christie, RN
Phone: 214-590-0664
Email: lucy.christie@utsouthwestern.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75390
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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