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Completed

NCT Number: NCT06277843

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

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.

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Key information

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Dhaka, 1000, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. Body temperature of preterm or low birthweight neonates and duration of time in euthermic range.

    Time frame: 2 hours per event

    Percentage of events maintained the body temperature in euthermic range among the enrolled preterm or low birthweight neonates.

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Directorate General of Health Services, Bangladesh
  • Poeticgem International Ltd
  • University of Dhaka

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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