HypothermiaPhase 4NCT01604447
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV
A Phase 4 study testing Hypothermia prevention with plastic bag and Hypothermia prevention without plastic bag in people with Hypothermia, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 72 hours
- Conditions the study is for
- Hypothermia
- What is being tested?
- Hypothermia prevention with plastic bag and Hypothermia prevention without plastic bag
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2012to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant admitted to the NICU
- Current weight less than 2,000g
- Being removed from incubator
Who cannot join
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV
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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.
Read the detailed description
Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.
- Conditions
- Hypothermia
- Being tested
- Hypothermia prevention with plastic bag, Hypothermia prevention without plastic bag
- Keywords
- Hypothermia, Newborn, Incubator, Plastic bag, Normothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermia prevention with plastic bagProcedure or surgery
Upon removal from the 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 and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
Hypothermia prevention without plastic bagProcedure or surgery
Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Incubator removal-torso bag | Active comparator | Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator Receives: Procedure: Hypothermia prevention with plastic bag |
| Incubator removal-no plastic bag | Placebo comparator | Standard bundling practices when removing the infant from the incubator. No plastic bag used. Receives: Procedure: Hypothermia prevention without plastic bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary temperature 36.5-37.5 degrees Celsius
Temperature taken per axilla for one minute
Measured: 1-72 hours
Secondary outcomes (16)
Blood pressure
Measure of extremity blood pressure per cuff taken during nursery stay
Measured: Up to 4 weeks
Blood glucose
Measure of blood glucose per laboratory value taken per heel stick
Measured: Up to 4 weeks
Seizure
Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.
Measured: Up to 4 weeks
Weight gain
Infant will be weighed daily and rates of weight gain will be calculated
Measured: Up to 4 weeks
Respiratory Distress Syndrome (RDS)
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Measured: Up to 4 weeks
Bronchopulmonary Dysplasia (BPD)
Oxygen requirement at 28 days of life
Measured: 28 days after birth
Pneumothorax
Either chest radiograph documentation or clinical deterioration consistent with air leak
Measured: Up to 4 weeks
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis
Measured: Up to 4 weeks
Major brain injury
Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
Measured: Up to 4 weeks
Necrotizing enterocolitis or intestinal perforation
Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1.
Measured: Up to 4 weeks
Pulmonary hemorrhage
Blood seen in the endotracheal tube and treated by physician
Measured: Up to 4 weeks
Death
Cardiorespiratory failure
Measured: Up to 4 weeks
Hyperthermia
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute
Measured: Up to 4 weeks
Length of time in incubator
Documentation of length of time spent in incubator and number of times placed in incubator
Measured: Up to 4 weeks
Room temperature and humidity
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
Measured: 1-72 hours
Incubator temperature and humidity
A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Children's of Alabama
- Responsible party
- Sponsor
- Investigators
- Waldemar A Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604447
- Sponsor's protocol ID
- UAB Neo 009
- Status last verified
- Feb 2015
- First submitted
- 21 May 2012
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV
- ClinicalTrials.gov ID
- NCT01604447
- Acronym / sponsor ID
- UAB Neo 009
- Conditions
- Hypothermia
- Keywords
- Hypothermia, Newborn, Incubator, Plastic bag, Normothermia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's of Alabama
- Study start
- Jun 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.
Detailed description
Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incubator removal-torso bag | Active comparator | Procedure: Hypothermia prevention with plastic bagUse plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator |
| Incubator removal-no plastic bag | Placebo comparator | Procedure: Hypothermia prevention without plastic bagStandard bundling practices when removing the infant from the incubator. No plastic bag used. |
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant admitted to the NICU
- Current weight less than 2,000g
- Being removed from incubator
Key exclusion criteria (3 listed)
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermia prevention with plastic bagUpon removal from the 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 and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first. | Procedure or surgery | Incubator removal-torso bag |
| Hypothermia prevention without plastic bagUpon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first. | Procedure or surgery | Incubator removal-no plastic bag |
Primary outcome
Axillary temperature 36.5-37.5 degrees Celsius
Time frame: 1-72 hours
Temperature taken per axilla for one minute
16 secondary outcomes
Blood pressure
Time frame: Up to 4 weeks
Blood glucose
Time frame: Up to 4 weeks
Seizure
Time frame: Up to 4 weeks
Weight gain
Time frame: Up to 4 weeks
Respiratory Distress Syndrome (RDS)
Time frame: Up to 4 weeks
Bronchopulmonary Dysplasia (BPD)
Time frame: 28 days after birth
Pneumothorax
Time frame: Up to 4 weeks
Sepsis
Time frame: Up to 4 weeks
Major brain injury
Time frame: Up to 4 weeks
Necrotizing enterocolitis or intestinal perforation
Time frame: Up to 4 weeks
Pulmonary hemorrhage
Time frame: Up to 4 weeks
Death
Time frame: Up to 4 weeks
Hyperthermia
Time frame: Up to 4 weeks
Length of time in incubator
Time frame: Up to 4 weeks
Room temperature and humidity
Time frame: 1-72 hours
Incubator temperature and humidity
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldemar A Carlo, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypothermia prevention with plastic bag and Hypothermia prevention without plastic bag in people with Hypothermia, run by University of Alabama at Birmingham at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary temperature 36.5-37.5 degrees Celsius (time frame: 1-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.