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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01604434
• Other study ID #: UAB Neo 008
• Status: Withdrawn
• Phase: N/A
• Start date: June 2012
• Est. completion date: October 2019

Study information

• Verified date: February 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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%.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

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.
• Incubator-no plastic bag
Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Children's Health System, Alabama

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary temperature 36.5-37.5 degrees Celsius	Temperature taken per axilla for 1 minute	1-72 hours
Secondary	Blood Pressure	Measure of extremity blood pressure per cuff taken during nursery stay	Up to 4 weeks
Secondary	Blood glucose	Measure of blood glucose per laboratory value taken per heel stick	Up to 4 weeks
Secondary	Seizure	Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.	Up to 4 weeks
Secondary	Weight gain	Infant will be weighed daily and rates of weight gain will be calculated	Up to 4 weeks
Secondary	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
Secondary	Bronchopulmonary dysplasia (BPD)	Oxygen requirement at 28 days after birth	28 days after birth
Secondary	Pneumothorax	Either chest radiograph documentation or clinical deterioration consistent with air leak	Up to 4 weeks
Secondary	Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis	Up to 4 weeks
Secondary	Major brain injury	Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound	Up to 4 weeks
Secondary	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
Secondary	Pulmonary hemorrhage	Blood seen in the endotracheal tube and treated by physician	Up to 4 weeks
Secondary	Death	Cardiorespiratory failure	Up to 4 weeks
Secondary	Hyperthermia	Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute	Up to 4 weeks
Secondary	Length of time in Incubator	Documentation of length of time spent in incubator and number of times placed in incubator	Up to 4 weeks
Secondary	Temperature and humidity	A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement	1 hour