Testing a thermal jacket to keep preterm and low birthweight neonates warm
Testing the Role of Thermal Jacket in Attaining and Maintaining Euthermia Among Preterm and LBW Neonates in Clinical Setting of Bangladesh
This study is testing a special thermal jacket to see if it helps keep preterm and low birthweight babies warm and safe from getting too cold.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh Academic / other |
| Locations | 3 sites (Lakshmipur, Chattogram and 2 other locations) |
| Trial ID | NCT06277869 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of a thermal jacket designed to maintain warmth in preterm and low birthweight neonates, who are at high risk of hypothermia. Conducted in three phases, the study will first collect baseline data, then introduce the thermal jackets in a randomized manner across selected hospitals, and finally assess the outcomes after the intervention. The neonates' thermal status will be monitored continuously, and mothers will be encouraged to provide Kangaroo Mother Care alongside the use of the thermal jacket. This approach seeks to improve the thermal regulation of vulnerable neonates during their critical early days.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm or low birthweight neonates who are eligible for Kangaroo Mother Care.
Not a fit: Patients who are on oxygen therapy, intravenous fluids, or have significant respiratory distress or congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of hypothermia in preterm and low birthweight neonates, potentially lowering neonatal mortality rates.
How similar studies have performed: Previous studies have shown promise in using thermal interventions for neonatal care, but this specific approach with the thermal jacket is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. KMC eligible neonates 2. Heart rate 100-160 per minute 3. Capillary Refill Time ≤ 3 sec 4. Respiratory rate 30-59 per minute 5. Breaths comfortable 6. Pink in room air Exclusion Criteria: 1. In nasogastric tube 2. In oxygen therapy 3. In intravenous fluid 4. Sign of respiratory distress 5. Prolonged or frequent apnea 6. Major surgical problem 7. Gross congenital anomaly
Where this trial is running
Lakshmipur, Chattogram and 2 other locations
- Lakshmipur District Hospital — Lakshmipur, Chattogram, Bangladesh (Recruiting)
- Kushtia 250 Bedded General Hospital — Kushtia, Khulna, Bangladesh (Recruiting)
- Jamalpur 250 Beded General Hospital — Jamalpur, Mymensingh, Bangladesh (Not_yet_recruiting)
Study contacts
- Principal investigator: Anisuddin Ahmed, MS — International Centre for Diarrhoeal Disease Research, Bangladesh
- Study coordinator: Anisuddin Ahmed, MS
- Email: anisuddin@icddrb.org
- Phone: +8801755571024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.