NCT06277843

Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.

Completed EARLY_PHASE1 Last updated 26 February 2024

What this trial tests

EARLY_PHASE1 trial testing Thermal Jacket in Preterm in 10 participants. Completed in 30 September 2022.

Timeline

13 June 2022

Primary endpoint
1 September 2022

30 September 2022

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	13 June 2022
Primary completion	1 September 2022
Estimated completion	30 September 2022
Sites	1 location across Bangladesh

Drugs / interventions tested

• Thermal Jacket

Conditions studied

• Preterm — all drugs for Preterm →
• Low Birthweight — all drugs for Low Birthweight →
• Hypothermia Neonatal — all drugs for Hypothermia Neonatal →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Adults 0 Hours to 72 Hours, any sex, with Preterm or Low Birthweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical safety trial of a thermal jacket among preterm or low birthweight neonates for hypothermia management at a tertiary-level health facility in Bangladesh
   Ahmed A, Rahman F, Patwary M, Ahmed S, et al ·
2. Clinical safety trial of a thermal jacket among preterm or low birthweight neonates for hypothermia management at a tertiary-level health facility in Bangladesh.
   Ahmed A, Rahman F, Patwary MH, Ahmed S, et al · · 2026 · PMID 41747079 · DOI 10.7189/jogh.16.04022