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

Phase 4

Completed

• Conditions: Hypothermia, Newborn
• Interventions: Procedure: Resuscitation- no plastic bag for temperature regulation; Procedure: Resuscitation and post resuscitation care with plastic bag

• Registration Number: NCT01403623
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-08
• Primary Completion: 2012-03
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard resuscitation- no plastic bag	Resuscitation- no plastic bag for temperature regulation	Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.
Resuscitation with plastic bag	Resuscitation and post resuscitation care with plastic bag	Plastic bag will be used during and after resuscitation to assist with temperature regulation.

Primary Outcome Measures

Name	Time	Method
Axillary temperature 36.5-37.5 degrees Celsius	1-4 hours	Temperature taken per axilla for 1 minute

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia