PretermEarly Phase 1NCT06277843
Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.
A Early Phase 1 study testing Thermal Jacket in people with Preterm and Low Birthweight, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity… Read more about this study
- Who is it for?
- Ages 0 to 72 hours
- Conditions the study is for
- Preterm, Low Birthweight, Hypothermia Neonatal
- What is being tested?
- Thermal Jacket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBangladesh
- Study dates
- 13 Jun 2022to 30 Sep 2022
- Phase
- Early Phase 1
- 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 0 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonate aged between 0-72 hours
- Birthweight between 1800g to 2000g
- No gross congenital anomaly
- Normal heart 100-160 per minute
- Capillary Refill Time ≤3 sec
- Respiratory rate 30-59 per minute
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- Breaths comfortably (no chest indrawing, No gasping)
- No sign of respiratory distress (respiratory rate within normal limit)
- Pink in room air (without oxygen therapy)
- H/O No prolonged or frequent apnea \& no visible apnea during study enrolment
- No major surgical problem
Who cannot join
- In nasogastric tube
- In oxygen therapy
- In intravenous fluid
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka, 1000
About this study
Official title: Development and Testing of a Low-cost and Reusable Thermal Jacket for Managing Preterm or Low-birth-weight Neonates in Bangladesh.
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.
Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation.
Read more
The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates.
Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours.
Read the detailed description
We will equip a single arm trial with no control group design, in which every enrolled neonate will get the experimental therapy (thermal jacket) for this phase. A thermal jacket trial on a preterm or LBW neonate will be considered an event. An event will be considered a success if the neonate can maintain the body temperature in the euthermic range (36.5°C-37.5°C) using the thermal jacket for two hours. Thus, the failure event will be if the thermal jacket fails to maintain euthermia for neonates for two hours. Suppose, the neonate's body temperature drops below 36.5°C or rises above 37.5°C, the neonate will be monitored for maximum 5 minutes. If not recovered from the state, the neonate then immediately will be removed from the event for the appropriate management under the study's responsibility.
- Conditions
- Preterm, Low Birthweight, Hypothermia Neonatal
- Being tested
- Thermal Jacket
- Keywords
- Preterm neonate, Low birthweight neonate, Kangaroo Mother Care, Thermal Jacket, Safety Trial
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal JacketDevice
In the intervention group, the enrolled preterm or low birthweight eligible neonates gets the intervention (Thermal Jacket) as a supplement of Kangaroo Mother Care (KMC).
| Study group | Role | What they receive |
|---|---|---|
| Thermal Jacket | Experimental | Not described Receives: Device: Thermal Jacket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature of preterm or low birthweight neonates and duration of time in euthermic range.
Percentage of events maintained the body temperature in euthermic range among the enrolled preterm or low birthweight neonates.
Measured: 2 hours per event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start13 Jun 2022
- Primary completion1 Sep 2022
- Study completion30 Sep 2022
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 PretermStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm non-randomized trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Directorate General of Health Services, Bangladesh, Poeticgem International Ltd, University of Dhaka
- Responsible party
- Sponsor
- Investigators
- Anisuddin Ahmed, MS, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277843
- Sponsor's protocol ID
- PR-21131
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmed A, Rahman F, Patwary MH, Ahmed S, Shahidullah M, Malqvist M, Rahman AE, El Arifeen S, Rahman SM. Clinical safety trial of a thermal jacket among preterm or low birthweight neonates for hypothermia management at a tertiary-level health facility in Bangladesh. J Glob Health. 2026 Feb 27;16:04022. doi: 10.7189/jogh.16.04022.
PubMed 41747079
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Low-cost and Reusable Thermal Jacket for Managing Preterm or Low-birth-weight Neonates in Bangladesh.
- ClinicalTrials.gov ID
- NCT06277843
- Acronym / sponsor ID
- PR-21131
- Conditions
- Preterm, Low Birthweight, Hypothermia Neonatal
- Keywords
- Preterm neonate, Low birthweight neonate, Kangaroo Mother Care, Thermal Jacket, Safety Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Directorate General of Health Services, Bangladesh, Poeticgem International Ltd, University of Dhaka
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Feb 2024 (actual)
- 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.
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.
Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation.
The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates.
Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours.
Detailed description
We will equip a single arm trial with no control group design, in which every enrolled neonate will get the experimental therapy (thermal jacket) for this phase. A thermal jacket trial on a preterm or LBW neonate will be considered an event. An event will be considered a success if the neonate can maintain the body temperature in the euthermic range (36.5°C-37.5°C) using the thermal jacket for two hours. Thus, the failure event will be if the thermal jacket fails to maintain euthermia for neonates for two hours. Suppose, the neonate's body temperature drops below 36.5°C or rises above 37.5°C, the neonate will be monitored for maximum 5 minutes. If not recovered from the state, the neonate then immediately will be removed from the event for the appropriate management under the study's responsibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Thermal Jacket | Experimental | Device: Thermal Jacket |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Neonate aged between 0-72 hours
- Birthweight between 1800g to 2000g
- No gross congenital anomaly
- Normal heart 100-160 per minute
- Capillary Refill Time ≤3 sec
Key exclusion criteria (3 listed)
- In nasogastric tube
- In oxygen therapy
- In intravenous fluid
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 |
|---|---|---|
| Thermal JacketIn the intervention group, the enrolled preterm or low birthweight eligible neonates gets the intervention (Thermal Jacket) as a supplement of Kangaroo Mother Care (KMC). | Device | Thermal Jacket |
Primary outcome
Body temperature of preterm or low birthweight neonates and duration of time in euthermic range.
Time frame: 2 hours per event
Percentage of events maintained the body temperature in euthermic range among the enrolled preterm or low birthweight neonates.
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 26 Feb 2024.
- Derived from this study: PubMed 41747079Ahmed A, Rahman F, Patwary MH, Ahmed S, Shahidullah M, Malqvist M, Rahman AE, El Arifeen S, Rahman SM. Clinical safety trial of a thermal jacket among preterm or low birthweight neonates for hypothermia management at a tertiary-level health facility in Bangladesh. J Glob Health. 2026 Feb 27;16:04022. doi: 10.7189/jogh.16.04022.
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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.
Anisuddin Ahmed, MS principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thermal Jacket in people with Preterm and Low Birthweight, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 11 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 26 Feb 2024. 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 Bangladesh. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Body temperature of preterm or low birthweight neonates and duration of time in euthermic range. (time frame: 2 hours per event). 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 NCT06277843, 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 26 Feb 2024.