HypothermiaPhase 4NCT01604460
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
A Phase 4 study testing Resuscitation with torso plastic bag and Resuscitation-no plastic bag in people with Hypothermia and 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 72 hours
- Conditions the study is for
- Hypothermia, Newborn
- What is being tested?
- Resuscitation with torso plastic bag and Resuscitation-no plastic bag
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2012to Nov 2012
- 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 minute to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age 37 weeks and greater
- Birth weight greater than 2,500gms
- Delivery in the hospital
Who cannot join
- Infant admitted to the NICU
- Birth weight less than 2,500gms
- 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 V
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 standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.
Read the detailed description
Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.
- Conditions
- Hypothermia, Newborn
- Being tested
- Resuscitation with torso plastic bag, Resuscitation-no plastic bag
- Keywords
- Hypothermia, Newborn, Plastic bag, Resuscitation
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation with torso plastic bagProcedure or surgery
Infant will be placed within 10 minutes of his birth 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. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.
Resuscitation-no plastic bagProcedure or surgery
Infant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation-no plastic bag | Sham comparator | Resuscitation per standard of care without a plastic bag Receives: Procedure: Resuscitation-no plastic bag |
| Resuscitation-torso bag | Active comparator | Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth Receives: Procedure: Resuscitation with torso 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 36.0-16.4 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
Secondary outcomes (4)
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis
Measured: Up to 72 hours
Death
Cardiorespiratory failure
Measured: Up to 72 hours
Hyperthermia
Axillary temperature > 38 degrees Celsius per axilla for one minute
Measured: Up to 72 hours
Room Temperature
A recording of the room temperature will be obtained with each axillary temperature measurement
Measured: 1-72 hours
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 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 275 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, MD, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604460
- Sponsor's protocol ID
- UAB Neo 010
- Status last verified
- Feb 2013
- First submitted
- 21 May 2012
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belsches TC, Tilly AE, Miller TR, Kambeyanda RH, Leadford A, Manasyan A, Chomba E, Ramani M, Ambalavanan N, Carlo WA. Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting. Pediatrics. 2013 Sep;132(3):e656-61. doi: 10.1542/peds.2013-0172. Epub 2013 Aug 26.
PubMed 23979082
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. 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 V
- ClinicalTrials.gov ID
- NCT01604460
- Acronym / sponsor ID
- UAB Neo 010
- Conditions
- Hypothermia, Newborn
- Keywords
- Hypothermia, Newborn, Plastic bag, Resuscitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's Health System, Alabama
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (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 standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.
Detailed description
Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 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-no plastic bag | Sham comparator | Procedure: Resuscitation-no plastic bagResuscitation per standard of care without a plastic bag |
| Resuscitation-torso bag | Active comparator | Procedure: Resuscitation with torso plastic bagUse of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Estimated gestational age 37 weeks and greater
- Birth weight greater than 2,500gms
- Delivery in the hospital
Key exclusion criteria (5 listed)
- Infant admitted to the NICU
- Birth weight less than 2,500gms
- 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 with torso plastic bagInfant will be placed within 10 minutes of his birth 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. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth. | Procedure or surgery | Resuscitation-torso bag |
| Resuscitation-no plastic bagInfant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery. | Procedure or surgery | Resuscitation-no plastic bag |
Primary outcome
Axillary temperature < 36.5 degrees Celsius
Time frame: 1-72 hours
Temperature taken per axilla at one hour after birth. Temperatures 36.0-16.4 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.
4 secondary outcomes
Sepsis
Time frame: Up to 72 hours
Death
Time frame: Up to 72 hours
Hyperthermia
Time frame: Up to 72 hours
Room Temperature
Time frame: 1-72 hours
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 11 Feb 2013.
- Derived from this study: PubMed 23979082Belsches TC, Tilly AE, Miller TR, Kambeyanda RH, Leadford A, Manasyan A, Chomba E, Ramani M, Ambalavanan N, Carlo WA. Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting. Pediatrics. 2013 Sep;132(3):e656-61. doi: 10.1542/peds.2013-0172. Epub 2013 Aug 26.
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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 Resuscitation with torso plastic bag and Resuscitation-no plastic bag in people with Hypothermia and 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 3 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: finished, as of the sponsor's last update on 11 Feb 2013. 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 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?
On the ClinicalTrials.gov record for NCT01604460, which also lists 1 linked publication.
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 11 Feb 2013.