An interventional study of Resuscitation-torso plastic bag and Resuscitation-partial-head plastic bag in Hypothermia and Immature Newborn, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in Zambia. Open to participants aged 1 Minute to 1 Hour. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's enrollment of 182 is above the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.
Procedure: Resuscitation-torso plastic bag
Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation.
Procedure: Resuscitation-partial-head plastic bag
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
Axillary temperature < 36.5 degrees Celsius
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and \< 32.0 will be classified as severe hypothermia
Time frame: 1-72 hours after birth
Seizure
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Time frame: Up to 4 weeks
Respiratory Distress Syndrome (RDS)
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Time frame: Up to 4 weeks
Pneumothorax
Either chest radiograph documentation or clinical deterioration consistent with air leak
Time frame: Up to 4 weeks
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis
Time frame: Up to 4 weeks
Necrotizing enterocolitis or intestinal perforation
Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's classification stage greater than one.
Time frame: Up to 4 weeks
Death
Cardiorespiratory failure
Time frame: Up to 4 weeks
Hyperthermia
Axillary temperature \> 38 degrees Celsius per temperature taken per axilla for one minute
Time frame: Up to 4 weeks
Temperature and humidity
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
Time frame: 1-72 hours after birth
Started Jun 2012 (actual). Primary completion is estimated for Sep 2027, 183 months after the start.
Of 132 non-industry interventional studies with no phase under Hypothermia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 183 months is above that.
Counting every sponsor, half of 135 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Aug 2026 → Sep 2027 and completion Aug 2026 → Sep 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →