Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-17 @ 6:25 AM
Study NCT ID:
NCT01604434
Status:
WITHDRAWN
Last Update Posted:
2019-02-20
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no personnel available to enroll in study- decision made to not complete', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axillary temperature 36.5-37.5 degrees Celsius', 'timeFrame': '1-72 hours', 'description': 'Temperature taken per axilla for 1 minute'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Up to 4 weeks', 'description': 'Measure of extremity blood pressure per cuff taken during nursery stay'}, {'measure': 'Blood glucose', 'timeFrame': 'Up to 4 weeks', 'description': 'Measure of blood glucose per laboratory value taken per heel stick'}, {'measure': 'Seizure', 'timeFrame': 'Up to 4 weeks', 'description': 'Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.'}, {'measure': 'Weight gain', 'timeFrame': 'Up to 4 weeks', 'description': 'Infant will be weighed daily and rates of weight gain will be calculated'}, {'measure': 'Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)', 'timeFrame': 'Up to 4 weeks', 'description': 'Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant'}, {'measure': 'Bronchopulmonary dysplasia (BPD)', 'timeFrame': '28 days after birth', 'description': 'Oxygen requirement at 28 days after birth'}, {'measure': 'Pneumothorax', 'timeFrame': 'Up to 4 weeks', 'description': 'Either chest radiograph documentation or clinical deterioration consistent with air leak'}, {'measure': 'Sepsis', 'timeFrame': 'Up to 4 weeks', 'description': 'Culture proven or culture negative clinically treated course consistent with sepsis'}, {'measure': 'Major brain injury', 'timeFrame': 'Up to 4 weeks', 'description': 'Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound'}, {'measure': 'Necrotizing enterocolitis or intestinal perforation', 'timeFrame': 'Up to 4 weeks', 'description': "Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocoliities per Bell's Classification stage greater than 1."}, {'measure': 'Pulmonary hemorrhage', 'timeFrame': 'Up to 4 weeks', 'description': 'Blood seen in the endotracheal tube and treated by physician'}, {'measure': 'Death', 'timeFrame': 'Up to 4 weeks', 'description': 'Cardiorespiratory failure'}, {'measure': 'Hyperthermia', 'timeFrame': 'Up to 4 weeks', 'description': 'Axillary temperature \\> 38 degrees Celsius per temperature taken per axilla for one minute'}, {'measure': 'Length of time in Incubator', 'timeFrame': 'Up to 4 weeks', 'description': 'Documentation of length of time spent in incubator and number of times placed in incubator'}, {'measure': 'Temperature and humidity', 'timeFrame': '1 hour', 'description': 'A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypothermia', 'Low birth Weight', 'Newborn', 'Incubator', 'Plastic bag'], 'conditions': ['Hypothermia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infant admitted to the NICU\n* Current weight between 1,000 and 2,500g\n* Being placed in an incubator\n\nExclusion Criteria:\n\n* Abdominal wall defect or myelomeningocele\n* Major congenital anomalies\n* Blistering skin disorder'}, 'identificationModule': {'nctId': 'NCT01604434', 'briefTitle': 'Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III', 'orgStudyIdInfo': {'id': 'UAB Neo 008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Incubator-no plastic bag', 'description': 'Placement into an incubator without a plastic bag', 'interventionNames': ['Procedure: Incubator-no plastic bag']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Incubator-torso bag', 'description': 'Placement into a plastic bag inside incubator', 'interventionNames': ['Procedure: Incubator-torso bag']}], 'interventions': [{'name': 'Incubator-torso bag', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Incubator-torso bag']}, {'name': 'Incubator-no plastic bag', 'type': 'PROCEDURE', 'description': 'Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.', 'armGroupLabels': ['Incubator-no plastic bag']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'University Teaching Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Waldemar A Carlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Health System, Alabama", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Edwin M. Dixon Professor of Pediatrics', 'investigatorFullName': 'Wally Carlo', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}