Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

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).

Study Overview

• Status: Completed
• Conditions: Hypothermia, Newborn
• Intervention / Treatment: Procedure: Resuscitation and post resuscitation care with plastic bag; Procedure: Resuscitation- no plastic bag for temperature regulation

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resuscitation with plastic bag; Plastic bag will be used during and after resuscitation to assist with temperature regulation.	Procedure: Resuscitation and post resuscitation care with plastic bag; Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
Sham Comparator: Standard resuscitation- no plastic bag; Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.	Procedure: Resuscitation- no plastic bag for temperature regulation; Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axillary temperature 36.5-37.5 degrees Celsius	Temperature taken per axilla for 1 minute	1-4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Measure of extremity blood pressure per cuff taken during nursery stay.	Duration of hospitalization-expected average of 4 weeks
Blood glucose	Measure of blood glucose per laboratory value taken per heelstick	Duration of hospitalization-expected average of 4 weeks
Seizure	Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.	Duration of hospitalization-expected average of 4 weeks
Death	Cardiorespiratory failure	Duration of hospitalization-expected average of 4 weeks
Weight gain	Infant will be weighed daily and rates of weight gain will be measured.	Duration of hospitalization-expected average of 4 weeks
Respiratory Distress Syndrome (RDS)	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant.	Duration of hospitalization-expected average of 4 weeks
Bronchopulmonary dysplasia (BPD)	Oxygen requirement at 28 days of life	28 days after birth
Pneumothorax	Either chest radiograph documentation or clinical deterioration consistent with air leak	Duration of hospitalization-expected average of 4 weeks
Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis.	Duration of hospitalization-expected average of 4 weeks
Major brain injury	Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound	Duration of hospitalization-expected average of 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 stage greater than one.	Duration of hospitalization-expected average of 4 weeks
Pulmonary hemorrhage	Blood seen in the endotracheal tube and treated by physician.	Duration of hospitalization-expected average of 4 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Alicia E Leadford, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Hypothermia; Newborn; Resuscitation; Plastic bag
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: UAB Neo 003