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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Procedure: Hypothermia prevention with plastic bag; Procedure: Hypothermia prevention without plastic bag

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%.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Infant admitted to the NICU
• Current weight less than 2,000g
• Being removed from 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
Active Comparator: Incubator removal-torso bag; Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator	Procedure: Hypothermia prevention with plastic bag; Upon removal from the 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 and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
Placebo Comparator: Incubator removal-no plastic bag; Standard bundling practices when removing the infant from the incubator. No plastic bag used.	Procedure: Hypothermia prevention without plastic bag; Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

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 one minute	1-72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Distress Syndrome (RDS)	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant	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
Necrotizing enterocolitis or intestinal perforation	Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1.	Up to 4 weeks
Blood pressure	Measure of extremity blood pressure per cuff taken during nursery stay	Up to 4 weeks
Blood glucose	Measure of blood glucose per laboratory value taken per heel stick	Up to 4 weeks
Seizure	Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.	Up to 4 weeks
Weight gain	Infant will be weighed daily and rates of weight gain will be calculated	Up to 4 weeks
Bronchopulmonary Dysplasia (BPD)	Oxygen requirement at 28 days of life	28 days after birth
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
Hyperthermia	Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute	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
Room temperature and humidity	A recording of the room temperature and humidity will be obtained with each axillary temperature measurement	1-72 hours
Incubator temperature and humidity	A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement	1 hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): February 1, 2015

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 (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 23, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Hypothermia; Newborn; Normothermia; Plastic bag; Incubator
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: UAB Neo 009