- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277869
Effectiveness Trial of Thermal Jacket
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Anisuddin Ahmed, MS
- Phone Number: +8801755571024
- Email: anisuddin@icddrb.org
Study Contact Backup
- Name: M.A Salam Khan, MS
- Phone Number: 88029886498
- Email: salamk@icddrb.org
Study Locations
-
-
Chattogram
-
Lakshmipur, Chattogram, Bangladesh, 3700
- Recruiting
- Lakshmipur District Hospital
-
Contact:
- Ahmed Kabir, MBBS
- Phone Number: 01842587456
- Email: laxmipur@hospital.dghs.gov.bd
-
-
Khulna
-
Kushtia, Khulna, Bangladesh, 7000
- Recruiting
- Kushtia 250 Bedded General Hospital
-
Contact:
- Md. Rafiqul Islam, MBBS
- Phone Number: 01829699289
- Email: kushtia@hospi.dghs.gov.bd
-
-
Mymensingh
-
Jamalpur, Mymensingh, Bangladesh, 2000
- Not yet recruiting
- Jamalpur 250 Beded General Hospital
-
Contact:
- Muhammad Mahfuzur Rahman, MBBS
- Phone Number: 01716267689
- Email: jamalpur@hospital.dghs.gov.bd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- In nasogastric tube
- In oxygen therapy
- In intravenous fluid
- Sign of respiratory distress
- Prolonged or frequent apnea
- Major surgical problem
- Gross congenital anomaly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thermal Jacket
As a intervention, the enrolled preterm or low birthweight neonates gets the thermal jacket as well as Kangaroo Mother Care for thermal care.
|
In the intervention group, the enrolled preterm or low birthweight eligible neonates gets the intervention Thermal Jacket as well as Kangaroo Mother Care.
Skin-to-Skin care, provided by primary caregiver.
|
Active Comparator: Kangaroo Mother Care
As a control, the enrolled preterm or low birthweight neonates gets the conventional Kangaroo Mother Care only.
|
Skin-to-Skin care, provided by primary caregiver.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 hours per event
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anisuddin Ahmed, MS, International Centre for Diarrhoeal Disease Research, Bangladesh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-22146
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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