Hypothermia, NewbornPhase 4NCT01403623
Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates
A Phase 4 study testing Resuscitation and post resuscitation care with plastic bag and Resuscitation- no plastic bag for temperature regulation in people with Hypothermia, Newborn, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothermia, Newborn
- What is being tested?
- Resuscitation and post resuscitation care with plastic bag and Resuscitation- no plastic bag for temperature regulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteZambia
- Study dates
- Aug 2011to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
- Delivery in the hospital.
Who cannot join
- Abdominal wall defect or myelomeningocele.
- Major congenital anomaly.
- Blistering skin disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries
The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).
Read the detailed description
Prevention
After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.
- Conditions
- Hypothermia, Newborn
- Being tested
- Resuscitation and post resuscitation care with plastic bag, Resuscitation- no plastic bag for temperature regulation
- Keywords
- Hypothermia, 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 and post resuscitation care with plastic bagProcedure or surgery
Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
Resuscitation- no plastic bag for temperature regulationProcedure or surgery
Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation with plastic bag | Active comparator | Plastic bag will be used during and after resuscitation to assist with temperature regulation. Receives: Procedure: Resuscitation and post resuscitation care with plastic bag |
| Standard resuscitation- no plastic bag | Sham comparator | Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation. Receives: Procedure: Resuscitation- no plastic bag for temperature regulation |
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 1 minute
Measured: 1-4 hours
Secondary outcomes (12)
Blood pressure
Measure of extremity blood pressure per cuff taken during nursery stay.
Measured: Duration of hospitalization-expected average of 4 weeks
Blood glucose
Measure of blood glucose per laboratory value taken per heelstick
Measured: Duration of hospitalization-expected average of 4 weeks
Seizure
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Measured: Duration of hospitalization-expected average of 4 weeks
Weight gain
Infant will be weighed daily and rates of weight gain will be measured.
Measured: Duration of hospitalization-expected average of 4 weeks
Respiratory Distress Syndrome (RDS)
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant.
Measured: Duration of hospitalization-expected average of 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: Duration of hospitalization-expected average of 4 weeks
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis.
Measured: Duration of hospitalization-expected average of 4 weeks
Major brain injury
Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
Measured: Duration of hospitalization-expected average of 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 stage greater than one.
Measured: Duration of hospitalization-expected average of 4 weeks
Pulmonary hemorrhage
Blood seen in the endotracheal tube and treated by physician.
Measured: Duration of hospitalization-expected average of 4 weeks
Death
Cardiorespiratory failure
Measured: Duration of hospitalization-expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionDec 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 Hypothermia, NewbornStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicia Leadford, MD, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Study director, University of Alabama at BirminghamAlicia E Leadford, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403623
- Sponsor's protocol ID
- UAB Neo 003
- Status last verified
- Aug 2013
- First submitted
- 27 Jun 2011
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leadford AE, Warren JB, Manasyan A, Chomba E, Salas AA, Schelonka R, Carlo WA. Plastic bags for prevention of hypothermia in preterm and low birth weight infants. Pediatrics. 2013 Jul;132(1):e128-34. doi: 10.1542/peds.2012-2030. Epub 2013 Jun 3.
PubMed 23733796
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries
- ClinicalTrials.gov ID
- NCT01403623
- Acronym / sponsor ID
- UAB Neo 003
- Conditions
- Hypothermia, Newborn
- Keywords
- Hypothermia, Newborn, Resuscitation, Plastic bag
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jul 2011 (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 placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).
Detailed description
Prevention
After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resuscitation with plastic bag | Active comparator | Procedure: Resuscitation and post resuscitation care with plastic bagPlastic bag will be used during and after resuscitation to assist with temperature regulation. |
| Standard resuscitation- no plastic bag | Sham comparator | Procedure: Resuscitation- no plastic bag for temperature regulationInfant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
- Delivery in the hospital.
Key exclusion criteria (3 listed)
- Abdominal wall defect or myelomeningocele.
- Major congenital anomaly.
- 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 and post resuscitation care with plastic bagInfant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour. | Procedure or surgery | Resuscitation with plastic bag |
| Resuscitation- no plastic bag for temperature regulationInfant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour. | Procedure or surgery | Standard resuscitation- no plastic bag |
Primary outcome
Axillary temperature 36.5-37.5 degrees Celsius
Time frame: 1-4 hours
Temperature taken per axilla for 1 minute
12 secondary outcomes
Blood pressure
Time frame: Duration of hospitalization-expected average of 4 weeks
Blood glucose
Time frame: Duration of hospitalization-expected average of 4 weeks
Seizure
Time frame: Duration of hospitalization-expected average of 4 weeks
Weight gain
Time frame: Duration of hospitalization-expected average of 4 weeks
Respiratory Distress Syndrome (RDS)
Time frame: Duration of hospitalization-expected average of 4 weeks
Bronchopulmonary dysplasia (BPD)
Time frame: 28 days after birth
Pneumothorax
Time frame: Duration of hospitalization-expected average of 4 weeks
Sepsis
Time frame: Duration of hospitalization-expected average of 4 weeks
Major brain injury
Time frame: Duration of hospitalization-expected average of 4 weeks
Necrotizing enterocolitis or intestinal perforation
Time frame: Duration of hospitalization-expected average of 4 weeks
Pulmonary hemorrhage
Time frame: Duration of hospitalization-expected average of 4 weeks
Death
Time frame: Duration of hospitalization-expected average of 4 weeks
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 21 Aug 2013.
- Derived from this study: PubMed 23733796Leadford AE, Warren JB, Manasyan A, Chomba E, Salas AA, Schelonka R, Carlo WA. Plastic bags for prevention of hypothermia in preterm and low birth weight infants. Pediatrics. 2013 Jul;132(1):e128-34. doi: 10.1542/peds.2012-2030. Epub 2013 Jun 3.
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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 study director
University of Alabama at Birmingham
Alicia E Leadford, 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 and post resuscitation care with plastic bag and Resuscitation- no plastic bag for temperature regulation in people with Hypothermia, 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 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 21 Aug 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 36.5-37.5 degrees Celsius (time frame: 1-4 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 NCT01403623, 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 21 Aug 2013.