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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01403623
Other study ID # UAB Neo 003
Secondary ID
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


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
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