Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
Primary Purpose
Hypothermia
Status
Withdrawn
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Incubator-torso bag
Incubator-no plastic bag
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring Hypothermia, Low birth Weight, Newborn, Incubator, Plastic bag
Eligibility Criteria
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
Sites / Locations
- University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Incubator-no plastic bag
Incubator-torso bag
Arm Description
Placement into an incubator without a plastic bag
Placement into a plastic bag inside incubator
Outcomes
Primary Outcome Measures
Axillary temperature 36.5-37.5 degrees Celsius
Temperature taken per axilla for 1 minute
Secondary Outcome Measures
Blood Pressure
Measure of extremity blood pressure per cuff taken during nursery stay
Blood glucose
Measure of blood glucose per laboratory value taken per heel stick
Seizure
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Weight gain
Infant will be weighed daily and rates of weight gain will be calculated
Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Bronchopulmonary dysplasia (BPD)
Oxygen requirement at 28 days after birth
Pneumothorax
Either chest radiograph documentation or clinical deterioration consistent with air leak
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis
Major brain injury
Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
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.
Pulmonary hemorrhage
Blood seen in the endotracheal tube and treated by physician
Death
Cardiorespiratory failure
Hyperthermia
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute
Length of time in Incubator
Documentation of length of time spent in incubator and number of times placed in incubator
Temperature and humidity
A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement
Full Information
NCT ID
NCT01604434
First Posted
May 21, 2012
Last Updated
February 18, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Children's Health System, Alabama
1. Study Identification
Unique Protocol Identification Number
NCT01604434
Brief Title
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
Official Title
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
no personnel available to enroll in study- decision made to not complete
Study Start Date
June 2012 (Anticipated)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Children's Health System, Alabama
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Hypothermia, Low birth Weight, Newborn, Incubator, Plastic bag
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Incubator-no plastic bag
Arm Type
Sham Comparator
Arm Description
Placement into an incubator without a plastic bag
Arm Title
Incubator-torso bag
Arm Type
Active Comparator
Arm Description
Placement into a plastic bag inside incubator
Intervention Type
Procedure
Intervention Name(s)
Incubator-torso bag
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Incubator-no plastic bag
Intervention Description
Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.
Primary Outcome Measure Information:
Title
Axillary temperature 36.5-37.5 degrees Celsius
Description
Temperature taken per axilla for 1 minute
Time Frame
1-72 hours
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Measure of extremity blood pressure per cuff taken during nursery stay
Time Frame
Up to 4 weeks
Title
Blood glucose
Description
Measure of blood glucose per laboratory value taken per heel stick
Time Frame
Up to 4 weeks
Title
Seizure
Description
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Time Frame
Up to 4 weeks
Title
Weight gain
Description
Infant will be weighed daily and rates of weight gain will be calculated
Time Frame
Up to 4 weeks
Title
Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)
Description
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Time Frame
Up to 4 weeks
Title
Bronchopulmonary dysplasia (BPD)
Description
Oxygen requirement at 28 days after birth
Time Frame
28 days after birth
Title
Pneumothorax
Description
Either chest radiograph documentation or clinical deterioration consistent with air leak
Time Frame
Up to 4 weeks
Title
Sepsis
Description
Culture proven or culture negative clinically treated course consistent with sepsis
Time Frame
Up to 4 weeks
Title
Major brain injury
Description
Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
Time Frame
Up to 4 weeks
Title
Necrotizing enterocolitis or intestinal perforation
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.
Time Frame
Up to 4 weeks
Title
Pulmonary hemorrhage
Description
Blood seen in the endotracheal tube and treated by physician
Time Frame
Up to 4 weeks
Title
Death
Description
Cardiorespiratory failure
Time Frame
Up to 4 weeks
Title
Hyperthermia
Description
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute
Time Frame
Up to 4 weeks
Title
Length of time in Incubator
Description
Documentation of length of time spent in incubator and number of times placed in incubator
Time Frame
Up to 4 weeks
Title
Temperature and humidity
Description
A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar A Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
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Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
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