Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
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Purpose
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 V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypothermia Newborn |
Procedure: Resuscitation with torso plastic bag Procedure: Resuscitation-no plastic bag |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part V |
- Axillary temperature < 36.5 degrees Celsius [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]Temperature taken per axilla at one hour after birth. Temperatures 36.0-16.4 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.
- Sepsis [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]Culture proven or culture negative clinically treated course consistent with sepsis
- Death [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]Cardiorespiratory failure
- Hyperthermia [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]Axillary temperature > 38 degrees Celsius per axilla for one minute
- Room Temperature [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]A recording of the room temperature will be obtained with each axillary temperature measurement
| Enrollment: | 275 |
| Study Start Date: | June 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: Resuscitation-no plastic bag
Resuscitation per standard of care without a plastic bag
|
Procedure: Resuscitation-no plastic bag
Infant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.
|
|
Active Comparator: Resuscitation-torso bag
Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth
|
Procedure: Resuscitation with torso plastic bag
Infant will be placed within 10 minutes of his birth into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.
|
Detailed Description:
Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.
Eligibility| Ages Eligible for Study: | up to 72 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Estimated gestational age 37 weeks and greater
- Birth weight greater than 2,500gms
- Delivery in the hospital
Exclusion Criteria:
- Infant admitted to the NICU
- Birth weight less than 2,500gms
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Contacts and Locations| Zambia | |
| University Teaching Hospital | |
| Lusaka, Zambia | |
| Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | Waldemar A. Carlo, MD, Edwin M. Dixon Professor of Pediatrics, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01604460 History of Changes |
| Other Study ID Numbers: | UAB Neo 010 |
| Study First Received: | May 21, 2012 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board Zambia: Research Ethics Committee |
Keywords provided by University of Alabama at Birmingham:
|
Hypothermia Newborn Plastic bag Resuscitation |
Additional relevant MeSH terms:
|
Hypothermia Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013