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

Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III

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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

Study Overview

• Status: Withdrawn
• Conditions: Hypothermia
• Intervention / Treatment: Procedure: Incubator-no plastic bag; Procedure: Incubator-torso bag

Detailed Description

Incubators in the developing world often lack humidifiers. The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum. By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming. This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infant admitted to the NICU
• Current weight between 1,000 and 2,500g
• Being placed in an incubator

Exclusion Criteria:

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• 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
Sham Comparator: Incubator-no plastic bag; Placement into an incubator without a plastic bag	Procedure: Incubator-no plastic bag; Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.
Active Comparator: Incubator-torso bag; Placement into a plastic bag inside incubator	Procedure: Incubator-torso bag; While being placed into an incubator, infant will be placed 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. The infant will be wrapped in a blanket over the plastic bag and will receive a cloth hat. He/she will remain in the bag for 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	1-72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Children's Health System, Alabama

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2012
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hypothermia; Newborn; Low birth Weight; Plastic bag; Incubator
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: UAB Neo 008