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

Development and Testing of a Low-cost and Reusable Thermal Jacket for Managing Preterm or Low-birth-weight Neonates in 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 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.

Study Overview

• Status: Completed
• Conditions: Preterm; Low Birthweight; Hypothermia Neonatal
• Intervention / Treatment: Device: Thermal Jacket

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Bangabandhu Sheikh Mujib Medical University (BSMMU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal Jacket	Device: Thermal Jacket; In the intervention group, the enrolled preterm or low birthweight eligible neonates gets the intervention (Thermal Jacket) as a supplement of Kangaroo Mother Care (KMC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature of preterm or low birthweight neonates and duration of time in euthermic range.	Percentage of events maintained the body temperature in euthermic range among the enrolled preterm or low birthweight neonates.	2 hours per event

Collaborators and Investigators

• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; University of Dhaka; Directorate General of Health Services (DGHS), Bangladesh; Poeticgem International Ltd
• Investigators: Principal Investigator: Anisuddin Ahmed, MS, International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Kangaroo Mother Care; Safety Trial; Preterm neonate; Low birthweight neonate; Thermal Jacket
• Additional Relevant MeSH Terms: Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Body Temperature Changes; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Birth Weight; Hypothermia
• Other Study ID Numbers: PR-21131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No