Preterm NeonatePhase 2NCT06277869
Effectiveness Trial of Thermal Jacket
A Phase 2 study testing Thermal Jacket and Kangaroo Mother Care in people with Preterm Neonate and Low Birthweight Neonate, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 3 sites 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?
- Any age
- Conditions the study is for
- Preterm Neonate, Low Birthweight Neonate
- What is being tested?
- Thermal Jacket and Kangaroo Mother Care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesBangladesh
- Study dates
- 1 Mar 2024to 31 Dec 2024
- Phase
- Phase 2
- 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
- KMC eligible neonates
- Heart rate 100-160 per minute
- Capillary Refill Time ≤ 3 sec
- Respiratory rate 30-59 per minute
- Breaths comfortable
- Pink in room air
Who cannot join
- In nasogastric tube
- In oxygen therapy
- In intravenous fluid
- Sign of respiratory distress
- Prolonged or frequent apnea
- Major surgical problem
- Gross congenital anomaly
Trial locations and contacts
3 sites in 1 country.
Bangladesh3 sites, 3 recruiting
- Not yet recruiting
Jamalpur 250 Beded General Hospital
Jamalpur, Mymensingh, 2000
Muhammad Mahfuzur Rahman, MBBS, 01716267689, jamalpur@hospital.dghs.gov.bd
- Recruiting
Kushtia 250 Bedded General Hospital
Kushtia, Khulna Division, 7000
Md. Rafiqul Islam, MBBS, 01829699289, kushtia@hospi.dghs.gov.bd
- Recruiting
Lakshmipur District Hospital
Lakshmīpur, Chattogram, 3700
Ahmed Kabir, MBBS, 01842587456, laxmipur@hospital.dghs.gov.bd
About this study
Official title: Testing the Role of Thermal Jacket in Attaining and Maintaining Euthermia Among Preterm and LBW Neonates in Clinical Setting of 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 Kangaroo Mother Care (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 low birthweight (LBW) neonates warm during transportation.
Read more
The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings.
Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.
Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh.
Read the detailed description
We will equip a cluster-randomized stepped-wedge trial design. We will select and onboard hospitals randomly from three districts in pre-intervention period which eventually go into post-intervention period. The study will be conducted in three phases. The pre-intervention period for eight weeks for baseline data collection. Then intervention period (introduce thermal jackets) for another 24 weeks, and post-intervention period for endline data collection for eight weeks. In the control phase, all the eligible neonates enrolled in the hospitals whose parents agree to participate in the study will be observed and monitored for their thermal status (euthermia, hypothermia, and hyperthermia). Once the hospitals shift to case phase the eligible neonates will be given with thermal jacket. The icddr,b team will observe and monitor the enrolled neonates' thermal status throughout the event period. For this study, the definition of an event is the data from an individual enrolled infant on six hours' basis. Thus, every twenty-four hours, we can collect four events from a single neonate. During thermal care uptake, let it be with KMC or thermal jacket, the axillary temperature of the enrolled neonates will be recorded every 60 minutes. Feeding history will be recorded until discharge. According to the national newborn health SOP, during both control and case phases, mothers will be encouraged to provide KMC. The thermal jacket will be offered to mother when KMC will be ceased or not given by the neonate's family members. The thermal jacket intervention will be ceased for each neonate if mother wants to provide KMC or doesn't wish to put the neonate on the thermal jacket anymore. Thermal jacket will be provided for the time period as long as mother or legal guardian wishes to keep their neonate in the jacket without any time limitation. Mothers or caregivers of each neonate will be provided with training on KMC and thermal jacket and due support during the uptake of the KMC and thermal jacket will be provided as well. The data those will be collected during the pre-phase will be the control data and data that will be collected during the post-phase will be the intervention data.
- Conditions
- Preterm Neonate, Low Birthweight Neonate
- Being tested
- Thermal Jacket, Kangaroo Mother Care
- Keywords
- Preterm neonate, Low birthweight neonate, Kangaroo Mother Care, Thermal Jacket
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 well as Kangaroo Mother Care.
Kangaroo Mother CareProcedure or surgery
Skin-to-Skin care, provided by primary caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Thermal Jacket | Experimental | As a intervention, the enrolled preterm or low birthweight neonates gets the thermal jacket as well as Kangaroo Mother Care for thermal care. Receives: Device: Thermal Jacket; Procedure: Kangaroo Mother Care |
| Kangaroo Mother Care | Active comparator | As a control, the enrolled preterm or low birthweight neonates gets the conventional Kangaroo Mother Care only. Receives: Procedure: Kangaroo Mother Care |
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 maintain the euthermic range.
The primary outcome of this phase is attainment and maintenance of euthermia, defined as i. Having reached to 36.5⁰ C for hypothermic neonates at any point of a single event, ii. Maintaining euthermia throughout the event and iii. Having risen the temperature up to the euthermic range within 1 hour if at any point neonate goes below euthermic range. The endpoint of each event will be ascertained for every neonate during the pre-phase and intervention-phase in the same manner regardless of whether the thermal jacket is used.
Measured: 6 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 start1 Mar 2024
- Primary completion22 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm NeonateStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Stepped wedge cluster randomised trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
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
- Responsible party
- Sponsor
- Investigators
- Anisuddin Ahmed, MS, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277869
- Sponsor's protocol ID
- PR-22146
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Role of Thermal Jacket in Attaining and Maintaining Euthermia Among Preterm and LBW Neonates in Clinical Setting of Bangladesh
- ClinicalTrials.gov ID
- NCT06277869
- Acronym / sponsor ID
- PR-22146
- Conditions
- Preterm Neonate, Low Birthweight Neonate
- Keywords
- Preterm neonate, Low birthweight neonate, Kangaroo Mother Care, Thermal Jacket
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- 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
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 22 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- 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 Kangaroo Mother Care (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 low birthweight (LBW) neonates warm during transportation.
The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings.
Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.
Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh.
Detailed description
We will equip a cluster-randomized stepped-wedge trial design. We will select and onboard hospitals randomly from three districts in pre-intervention period which eventually go into post-intervention period. The study will be conducted in three phases. The pre-intervention period for eight weeks for baseline data collection. Then intervention period (introduce thermal jackets) for another 24 weeks, and post-intervention period for endline data collection for eight weeks. In the control phase, all the eligible neonates enrolled in the hospitals whose parents agree to participate in the study will be observed and monitored for their thermal status (euthermia, hypothermia, and hyperthermia). Once the hospitals shift to case phase the eligible neonates will be given with thermal jacket. The icddr,b team will observe and monitor the enrolled neonates' thermal status throughout the event period. For this study, the definition of an event is the data from an individual enrolled infant on six hours' basis. Thus, every twenty-four hours, we can collect four events from a single neonate. During thermal care uptake, let it be with KMC or thermal jacket, the axillary temperature of the enrolled neonates will be recorded every 60 minutes. Feeding history will be recorded until discharge. According to the national newborn health SOP, during both control and case phases, mothers will be encouraged to provide KMC. The thermal jacket will be offered to mother when KMC will be ceased or not given by the neonate's family members. The thermal jacket intervention will be ceased for each neonate if mother wants to provide KMC or doesn't wish to put the neonate on the thermal jacket anymore. Thermal jacket will be provided for the time period as long as mother or legal guardian wishes to keep their neonate in the jacket without any time limitation. Mothers or caregivers of each neonate will be provided with training on KMC and thermal jacket and due support during the uptake of the KMC and thermal jacket will be provided as well. The data those will be collected during the pre-phase will be the control data and data that will be collected during the post-phase will be the intervention data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| Thermal Jacket | Experimental | Device: Thermal Jacket, Procedure: Kangaroo Mother CareAs a intervention, the enrolled preterm or low birthweight neonates gets the thermal jacket as well as Kangaroo Mother Care for thermal care. |
| Kangaroo Mother Care | Active comparator | Procedure: Kangaroo Mother CareAs a control, the enrolled preterm or low birthweight neonates gets the conventional Kangaroo Mother Care only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- KMC eligible neonates
- Heart rate 100-160 per minute
- Capillary Refill Time ≤ 3 sec
- Respiratory rate 30-59 per minute
- Breaths comfortable
Key exclusion criteria (7 listed)
- In nasogastric tube
- In oxygen therapy
- In intravenous fluid
- Sign of respiratory distress
- Prolonged or frequent apnea
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 well as Kangaroo Mother Care. | Device | Thermal Jacket |
| Kangaroo Mother CareSkin-to-Skin care, provided by primary caregiver. | Procedure or surgery | Kangaroo Mother Care, Thermal Jacket |
Primary outcome
Body temperature of preterm or low birthweight neonates maintain the euthermic range.
Time frame: 6 hours per event
The primary outcome of this phase is attainment and maintenance of euthermia, defined as i. Having reached to 36.5⁰ C for hypothermic neonates at any point of a single event, ii. Maintaining euthermia throughout the event and iii. Having risen the temperature up to the euthermic range within 1 hour if at any point neonate goes below euthermic range. The endpoint of each event will be ascertained for every neonate during the pre-phase and intervention-phase in the same manner regardless of whether the thermal jacket is used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thermal Jacket and Kangaroo Mother Care in people with Preterm Neonate and Low Birthweight Neonate, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 3 sites 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anisuddin Ahmed, MS (+8801755571024, anisuddin@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature of preterm or low birthweight neonates maintain the euthermic range. (time frame: 6 hours per event). 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 7 Mar 2024.