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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT01403623

Collaborator

(none)

106

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Hypothermia, Newborn	Procedure: Resuscitation and post resuscitation care with plastic bag Procedure: Resuscitation- no plastic bag for temperature regulation	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Resuscitation with plastic bag Plastic bag will be used during and after resuscitation to assist with temperature regulation.	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.
Sham Comparator: Standard resuscitation- no plastic bag Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Resuscitation with plastic bag

Plastic bag will be used during and after resuscitation to assist with temperature regulation.

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.

Sham Comparator: Standard resuscitation- no plastic bag

Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Axillary temperature 36.5-37.5 degrees Celsius [1-4 hours]
Temperature taken per axilla for 1 minute

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Teaching Hospital	Lusaka		Zambia

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Study Director: Waldemar A Carlo, MD, University of Alabama at Birmingham
Principal Investigator: Alicia E Leadford, MD, University of Alabama at Birmingham