Clinical trial NCT06277843: Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.
Official title: Development and Testing of a Low-cost and Reusable Thermal Jacket for Managing Preterm or Low-birth-weight Neonates in Bangladesh.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Preterm
Low Birthweight
Hypothermia Neonatal
Keywords: Preterm neonate
Low birthweight neonate
Kangaroo Mother Care
Thermal Jacket
Safety Trial
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Directorate General of Health Services (DGHS), Bangladesh
name: Poeticgem International Ltd
name: University of Dhaka
First posted: 2024-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm non-randomized trial
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Neonate aged between 0-72 hours
2. Birthweight between 1800g to 2000g
3. No gross congenital anomaly
4. Normal heart 100-160 per minute
5. Capillary Refill Time ≤3 sec
6. Respiratory rate 30-59 per minute
7. Breaths comfortably (no chest indrawing, No gasping)
8. No sign of respiratory distress (respiratory rate within normal limit)
9. Pink in room air (without oxygen therapy)
10. H/O No prolonged or frequent apnea \& no visible apnea during study enrolment
11. No major surgical problem

Exclusion Criteria:

1. In nasogastric tube
2. In oxygen therapy
3. In intravenous fluid

Primary outcomes:
measure: Body temperature of preterm or low birthweight neonates and duration of time in euthermic range.
timeFrame: 2 hours per event
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University (BSMMU)
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Anisuddin Ahmed, MS
role: PRINCIPAL_INVESTIGATOR
References: