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

Preterm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06277843
• Other study ID #: PR-21131
• Status: Completed
• Phase: Early Phase 1
• Start date: June 13, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2024
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Hypothermia
• Hypothermia Neonatal
• Low Birthweight
• Premature Birth
• Preterm

Intervention

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).

Locations

Country	Name	City	State
Bangladesh	Bangabandhu Sheikh Mujib Medical University (BSMMU)	Dhaka

Sponsors (5)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Directorate General of Health Services (DGHS), Bangladesh, Poeticgem International Ltd, University of Dhaka

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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