Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV

Phase 4

Completed

• Conditions: Hypothermia
• Interventions: Procedure: Hypothermia prevention with plastic bag; Procedure: Hypothermia prevention without plastic bag

• Registration Number: NCT01604447
• Lead Sponsor: University of Alabama at Birmingham

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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

Detailed Description

Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

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: 2012-05-21
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-23
• Study Start: 2012-06
• Primary Completion: 2014-08
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Infant admitted to the NICU
• Current weight less than 2,000g
• Being removed from incubator

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Exclusion Criteria

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incubator removal-torso bag	Hypothermia prevention with plastic bag	Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator
Incubator removal-no plastic bag	Hypothermia prevention without plastic bag	Standard bundling practices when removing the infant from the incubator. No plastic bag used.

Primary Outcome Measures

Name	Time	Method
Axillary temperature 36.5-37.5 degrees Celsius	1-72 hours	Temperature taken per axilla for one minute

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Up to 4 weeks	Measure of extremity blood pressure per cuff taken during nursery stay
Blood glucose	Up to 4 weeks	Measure of blood glucose per laboratory value taken per heel stick
Bronchopulmonary Dysplasia (BPD)	28 days after birth	Oxygen requirement at 28 days of life
Pulmonary hemorrhage	Up to 4 weeks	Blood seen in the endotracheal tube and treated by physician
Weight gain	Up to 4 weeks	Infant will be weighed daily and rates of weight gain will be calculated
Respiratory Distress Syndrome (RDS)	Up to 4 weeks	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Seizure	Up to 4 weeks	Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.
Necrotizing enterocolitis or intestinal perforation	Up to 4 weeks	Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1.
Length of time in incubator	Up to 4 weeks	Documentation of length of time spent in incubator and number of times placed in incubator
Room temperature and humidity	1-72 hours	A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
Pneumothorax	Up to 4 weeks	Either chest radiograph documentation or clinical deterioration consistent with air leak
Sepsis	Up to 4 weeks	Culture proven or culture negative clinically treated course consistent with sepsis
Major brain injury	Up to 4 weeks	Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
Death	Up to 4 weeks	Cardiorespiratory failure
Hyperthermia	Up to 4 weeks	Axillary temperature \> 38 degrees Celsius per temperature taken per axilla for 1 minute
Incubator temperature and humidity	1 hour	A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia