HypothermiaNCT01604421
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part II
A study testing Thermoregulation with 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 120 days
- Conditions the study is for
- Hypothermia
- What is being tested?
- Thermoregulation with plastic bag
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteZambia
- Study dates
- Feb 2013to Oct 2019
- Phase
- Interventional
- 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 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g
- Delivery in the hospital
Who cannot join
- Infant admitted to the NICU
- Birth weight less than 1400 gms
- 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 II
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 II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.
Read the detailed description
Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
- Conditions
- Hypothermia
- Being tested
- Thermoregulation-standard care, Thermoregulation with plastic bag
- Keywords
- Hypothermia, Low birth weight, Newborn, Plastic bag, Thermoregulation
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoregulation-standard careProcedure or surgery
Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.
Thermoregulation with plastic bagProcedure or surgery
One hour after birth, the infant will be placed into a plastic bag up 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. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Thermoregulation-standard care | Sham comparator | Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first. Receives: Procedure: Thermoregulation-standard care |
| Thermoregulation-with plastic bag | Active comparator | Thermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first. Receives: Procedure: Thermoregulation with plastic bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary temperature < 36.5 degrees Celsius
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and <32.0 as severe hypothermia.
Measured: Discharge or 24 hours after birth
Secondary outcomes (8)
Seizure
Seizure activity diagnosed by medical director or nurse. No electroencephalogram will be done.
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
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
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
Death
Cardiorespiratory failure
Measured: Up to 4 weeks
Hyperthermia
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute
Measured: Up to 4 weeks
Temperature and humidity
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
Measured: 1-72 hours after birth
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 startFeb 2013 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: no personnel available to enroll patients- decision made to not complete study
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Health System, Alabama
- Responsible party
- Principal investigator, Wally Carlo, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604421
- Sponsor's protocol ID
- UAB Neo 007
- Status last verified
- Feb 2019
- First submitted
- 21 May 2012
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. 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 II
- ClinicalTrials.gov ID
- NCT01604421
- Acronym / sponsor ID
- UAB Neo 007
- Conditions
- Hypothermia
- Keywords
- Hypothermia, Low birth weight, Newborn, Plastic bag, Thermoregulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no personnel available to enroll patients- decision made to not complete study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's Health System, Alabama
- Study start
- Feb 2013 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- 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 II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.
Detailed description
Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% relative risk reduction), a sample size of 182 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 |
|---|---|---|
| Thermoregulation-standard care | Sham comparator | Procedure: Thermoregulation-standard careStandard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first. |
| Thermoregulation-with plastic bag | Active comparator | Procedure: Thermoregulation with plastic bagThermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first. |
Who may qualify
- Ages
- 1 hour to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g
- Delivery in the hospital
Key exclusion criteria (5 listed)
- Infant admitted to the NICU
- Birth weight less than 1400 gms
- 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 |
|---|---|---|
| Thermoregulation-standard careStandard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first. | Procedure or surgery | Thermoregulation-standard care |
| Thermoregulation with plastic bagOne hour after birth, the infant will be placed into a plastic bag up 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. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first. | Procedure or surgery | Thermoregulation-with plastic bag |
Primary outcome
Axillary temperature < 36.5 degrees Celsius
Time frame: Discharge or 24 hours after birth
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and <32.0 as severe hypothermia.
8 secondary outcomes
Seizure
Time frame: Up to 4 weeks
Respiratory Distress Syndrome (RDS)
Time frame: Up to 4 weeks
Pneumothorax
Time frame: Up to 4 weeks
Sepsis
Time frame: Up to 4 weeks
Necrotizing enterocolitis or intestinal perforation
Time frame: Up to 4 weeks
Death
Time frame: Up to 4 weeks
Hyperthermia
Time frame: Up to 4 weeks
Temperature and humidity
Time frame: 1-72 hours after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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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 study testing Thermoregulation with 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 20 Feb 2019. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 degrees Celsius (time frame: Discharge or 24 hours after birth). 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 20 Feb 2019.