Clinical trial NCT01403623: Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates
Official title: A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothermia, Newborn
Keywords: Hypothermia
Newborn
Resuscitation
Plastic bag
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (\< 36.5 degrees C) without increasing hyperthermia (\> 37.5 degrees C).

Detailed description: Prevention

After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.

Eligibility criteria: Inclusion Criteria:

* Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
* Delivery in the hospital.

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele.
* Major congenital anomaly.
* Blistering skin disorder.

Primary outcomes:
measure: Axillary temperature 36.5-37.5 degrees Celsius
timeFrame: 1-4 hours
Secondary outcomes:
measure: Blood pressure
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Blood glucose
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Seizure
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Weight gain
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Respiratory Distress Syndrome (RDS)
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: 28 days after birth
measure: Pneumothorax
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Sepsis
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Major brain injury
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Necrotizing enterocolitis or intestinal perforation
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Pulmonary hemorrhage
timeFrame: Duration of hospitalization-expected average of 4 weeks
measure: Death
timeFrame: Duration of hospitalization-expected average of 4 weeks
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Alicia E Leadford, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leadford AE, Warren JB, Manasyan A, Chomba E, Salas AA, Schelonka R, Carlo WA. Plastic bags for prevention of hypothermia in preterm and low birth weight infants. Pediatrics. 2013 Jul;132(1):e128-34. doi: 10.1542/peds.2012-2030. Epub 2013 Jun 3.