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

NCT06277843 | Completed Early Phase 1 DMC

• 1 other identifier: PR-21131
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Low Birthweight; Hypothermia Neonatal

Keywords

Preterm neonate; Low birthweight neonate; Kangaroo Mother Care; Thermal Jacket; Safety Trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Thermal Jacket

EXPERIMENTAL

Device: Thermal Jacket

Interventions

Thermal Jacket DEVICE

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).

Thermal Jacket

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• In nasogastric tube
• In oxygen therapy
• In intravenous fluid

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: collaborator
• Directorate General of Health Services (DGHS), Bangladesh: collaborator
• Poeticgem International Ltd: collaborator
• University of Dhaka: collaborator

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anisuddin Ahmed, MS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm non-randomized trial

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: June 13, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

BA (1)