Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-17 @ 6:25 AM
Study NCT ID:
NCT01604434
Status:
WITHDRAWN
Last Update Posted:
2019-02-20
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III
Status:
WITHDRAWN
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no personnel available to enroll in study- decision made to not complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.
Detailed Description:
Incubators in the developing world often lack humidifiers. The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum. By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming. This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: