Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000845538
Ethics application status
Approved
Date submitted
2/03/2024
Date registered
8/07/2024
Date last updated
8/07/2024
Date data sharing statement initially provided
8/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Role of Thermal Jacket as a supplement to Kangaroo Mother Care (KMC) among preterm or low birthweight neonates.
Scientific title
Testing the role of thermal jacket in attaining and maintaining euthermia among preterm and low birthweight neonates in clinical setting of Bangladesh.
Secondary ID [1] 311607 0
NIl known
Universal Trial Number (UTN)
Trial acronym
Linked study record
The study (Effectiveness Trial) registered in ClinicalTrial.gov with Trial id: NCT06277869 is a follow up study of this trial (Efficacy Trial).

Health condition
Health condition(s) or problem(s) studied:
Neonatal Hypothermia 333024 0
Low birthweight 333027 0
Preterm neonate 333028 0
Condition category
Condition code
Reproductive Health and Childbirth 329710 329710 0 0
Complications of newborn
Public Health 329711 329711 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, Thermal Jacket, is a thermal care device consisting of a chemical warming pad (CWP) and an insulating jacket. The intervention can be administered by mothers or primary caregivers and, since this is a supplement to Kangaroo Mother Care (KMC), mothers or primary caregivers can use this whenever providing KMC is not possible. The intervention can maintain a temperature between 36.5°C and 37.5°C for 2 hours. Moreover, the device contains a transparent window above the neonate's chest, which helps observe the neonate’s breathing frequency.

During a day, thermal jacket doesn’t have any time limits of use. Once a neonate is wrapped by the thermal jacket, he/she should stay in the jacket for 2 hours (maximum) at a time. Moreover, the World Health Organization (WHO) and Bangladesh National Guideline on Kangaroo Mother Care suggest the use of KMC for 8-24 hours per day, until neonates gain a weight of 2500 gm. As a supplement to KMC, thermal jacket is suggested to use as supplement to KMC until the neonate reaches the weight of 2500 gm
Intervention code [1] 328060 0
Treatment: Devices
Comparator / control treatment
Kangaroo Mother Care (KMC), provided typically by mothers or other family members involves continuous and prolonged skin-to-skin contact between the mother or caregiver and the neonate. The neonate is secured to the caregiver's chest using physical materials such as a KMC sling or binder. The infant is placed between the mother's breasts, with the head turned to one side and slightly upturned to facilitate breathing and allow for eye-to-eye contact. To begin with, it may not be possible for the mother to provide KMC for a prolonged period of time. But each session of KMC should last at least an hour. The aim should be to provide KMC as long as possible preferably 8-24 hours a day. KMC usually begins in a hospital setting and continues at home after discharge. To ensure adherence and fidelity to KMC, caregivers will be monitored by study physicians and study nurses.
WHO suggests to use KMC 8-24 hours in a day. And generally it is suggested to use untill neonate gain an optimal weight (2500 gm)
Control group
Active

Outcomes
Primary outcome [1] 337508 0
Axillary temperature of the enrolled preterm or low birthweight neonates.
Timepoint [1] 337508 0
The outcome will be assessed for one day since we will collect altogether 10 events (5 events of KMC and 5 events of Thermal jacket) and each event duration is 2 hours. The outcome measurements therefore will be calculated for all the 10 events in the same manner
Secondary outcome [1] 432339 0
Nil
Timepoint [1] 432339 0
Nil

Eligibility
Key inclusion criteria
Neonate aged between 0-72 hours
Heart rate 100-160 per minute
Capillary Refill Time <= 3 sec
Respiratory rate 30-59 per minute
Breaths comfortable
Pink in the room air
Minimum age
0 Hours
Maximum age
72 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In nasogastric tube
In oxygen therapy
In intravenous fluid
Sign of respiratory distress
Prolonged or frequent apnea
Major surgical problem
Gross congenital anomaly

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/12/2023
Date of last participant enrolment
Anticipated
Actual
29/03/2024
Date of last data collection
Anticipated
Actual
1/04/2024
Sample size
Target
20
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 26177 0
Bangladesh
State/province [1] 26177 0
Dhaka

Funding & Sponsors
Funding source category [1] 315915 0
Government body
Name [1] 315915 0
Ministry of Health and Family Welfare, Bangladesh
Country [1] 315915 0
Bangladesh
Primary sponsor type
Other
Name
International Centre for Diarrhoeal Disease Research, Bangladesh
Address
Country
Bangladesh
Secondary sponsor category [1] 318068 0
None
Name [1] 318068 0
Address [1] 318068 0
Country [1] 318068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314761 0
Ethical Review Committee (ERC)
Ethics committee address [1] 314761 0
C/- IRB Secretariat, Research Administration, icdddr,b 68 Shaheed Tajuddin Ahmed Sarani (Mohakhali) Dhaka 1212, Bangladesh
Ethics committee country [1] 314761 0
Bangladesh
Date submitted for ethics approval [1] 314761 0
19/11/2022
Approval date [1] 314761 0
27/12/2022
Ethics approval number [1] 314761 0

Summary
Brief summary
The aim of this trial is to determine whether the thermal jacket is effective to attain and maintain euthermia (36.5°C to 37.5°C) for hypothermic (35.0°C to 36.4°C) preterm or low birthweight neonates in clinical settings in Bangladesh. For this we will equip a multi-block crossover randomized control trial design, in which every enrolled neonate will get the experimental treatment (thermal jacket) and comparator treatment (kangaroo mother care). Each event will either consist of thermal jacket or kangaroo mother care, where an event is a follow up period of 2 hours. The body temperature will then be compared to assess the efficacy of thermal jacket as a supplement to kangaroo mother care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132642 0
Mr Anisuddin Ahmed
Address 132642 0
International Centre for Diarrhoeal Disease Research, Bangladesh, 68 Shaheed Tajuddin Ahmed Ave, Dhaka 1212
Country 132642 0
Bangladesh
Phone 132642 0
+8801755571024
Fax 132642 0
Email 132642 0
[email protected]
Contact person for public queries
Name 132643 0
Anisuddin Ahmed
Address 132643 0
International Centre for Diarrhoeal Disease Research, Bangladesh, 68 Shaheed Tajuddin Ahmed Ave, Dhaka 1212
Country 132643 0
Bangladesh
Phone 132643 0
+8801755571024
Fax 132643 0
Email 132643 0
[email protected]
Contact person for scientific queries
Name 132644 0
Anisuddin Ahmed
Address 132644 0
International Centre for Diarrhoeal Disease Research, Bangladesh, 68 Shaheed Tajuddin Ahmed Ave, Dhaka 1212
Country 132644 0
Bangladesh
Phone 132644 0
+8801755571024
Fax 132644 0
Email 132644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.