HypothermiaNCT01604317
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I
A study testing Resuscitation-torso plastic bag and Resuscitation-partial-head plastic bag in people with Hypothermia and Immature Newborn, 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 minute to 1 hour
- Conditions the study is for
- Hypothermia, Immature Newborn
- What is being tested?
- Resuscitation-torso plastic bag and Resuscitation-partial-head plastic bag
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2012to 22 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 minute to 1 hour
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
- Delivery in the hospital
Who cannot join
- Infant admitted to the NICU
- Birth weight less than 1,400g
- 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 I
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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
Read the detailed description
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% 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, Immature Newborn
- Being tested
- Resuscitation-torso plastic bag, Resuscitation-partial-head plastic bag
- Keywords
- Hypothermia, Low birth Weight, Newborn, Resuscitation, Plastic bag
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation-torso plastic bagProcedure or surgery
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
Resuscitation-partial-head plastic bagProcedure or surgery
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation-torso plastic bag | Active comparator | Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation. Receives: Procedure: Resuscitation-torso plastic bag |
| Resuscitation-partial-head plastic bag | Active comparator | Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation. Receives: Procedure: Resuscitation-partial-head 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 will be classified as severe hypothermia
Measured: 1-72 hours after birth
Secondary outcomes (8)
Seizure
Seizure activity diagnosed by medical doctor 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 one.
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 startJun 2012
- Primary completion22 Sep 2027 (estimated)
- Study completion22 Sep 2027 (estimated)
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
- 182 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, Waldemar A. 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
- NCT01604317
- Sponsor's protocol ID
- UAB Neo 005
- Other IDs
- Perinatal Health/Human, Childrens Centennial, Caduceus Club
- Status last verified
- Sep 2026
- First submitted
- 21 May 2012
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. 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 I
- ClinicalTrials.gov ID
- NCT01604317
- Acronym / sponsor ID
- UAB Neo 005
- Conditions
- Hypothermia, Immature Newborn
- Keywords
- Hypothermia, Low birth Weight, Newborn, Resuscitation, Plastic bag
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's Health System, Alabama
- Study start
- Jun 2012 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 22 Sep 2027 (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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
Detailed description
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% 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 |
|---|---|---|
| Resuscitation-torso plastic bag | Active comparator | Procedure: Resuscitation-torso plastic bagResuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation. |
| Resuscitation-partial-head plastic bag | Active comparator | Procedure: Resuscitation-partial-head plastic bagResuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation. |
Who may qualify
- Ages
- 1 minute to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
- Delivery in the hospital
Key exclusion criteria (5 listed)
- Infant admitted to the NICU
- Birth weight less than 1,400g
- 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 |
|---|---|---|
| Resuscitation-torso plastic bagInfant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. | Procedure or surgery | Resuscitation-torso plastic bag |
| Resuscitation-partial-head plastic bagInfant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. | Procedure or surgery | Resuscitation-partial-head plastic bag |
Primary outcome
Axillary temperature < 36.5 degrees Celsius
Time frame: 1-72 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 will be classified 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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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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 Resuscitation-torso plastic bag and Resuscitation-partial-head plastic bag in people with Hypothermia and Immature Newborn, 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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: 1-72 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 25 Sep 2026.