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

Hypothermia, Newborn Clinical Trial

Official title:

A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403623
• Other study ID #: UAB Neo 003
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2011
• Last updated: August 19, 2013
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Delivery in the hospital.

Exclusion Criteria:

• Abdominal wall defect or myelomeningocele.

• Major congenital anomaly.

• Blistering skin disorder.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Newborn

Intervention

Procedure:
• Resuscitation and post resuscitation care with plastic bag
Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
• Resuscitation- no plastic bag for temperature regulation
Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

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	1-4 hours	Yes
Secondary	Blood pressure	Measure of extremity blood pressure per cuff taken during nursery stay.	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Blood glucose	Measure of blood glucose per laboratory value taken per heelstick	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Seizure	Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Weight gain	Infant will be weighed daily and rates of weight gain will be measured.	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Respiratory Distress Syndrome (RDS)	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant.	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Bronchopulmonary dysplasia (BPD)	Oxygen requirement at 28 days of life	28 days after birth	Yes
Secondary	Pneumothorax	Either chest radiograph documentation or clinical deterioration consistent with air leak	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis.	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Major brain injury	Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Necrotizing enterocolitis or intestinal perforation	Documentation of pneumatosis or intestinal perforation on x ray or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than one.	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Pulmonary hemorrhage	Blood seen in the endotracheal tube and treated by physician.	Duration of hospitalization-expected average of 4 weeks	Yes
Secondary	Death	Cardiorespiratory failure	Duration of hospitalization-expected average of 4 weeks	Yes