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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.
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Scientific title
Testing the role of thermal jacket in attaining and maintaining euthermia among preterm and low birthweight neonates in clinical setting of Bangladesh.
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Secondary ID [1]
311607
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NIl known
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Universal Trial Number (UTN)
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Trial acronym
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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).
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Health condition
Health condition(s) or problem(s) studied:
Neonatal Hypothermia
333024
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Low birthweight
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Preterm neonate
333028
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Condition category
Condition code
Reproductive Health and Childbirth
329710
329710
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0
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Complications of newborn
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Public Health
329711
329711
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0
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Epidemiology
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
328060
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Treatment: Devices
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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)
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Control group
Active
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Outcomes
Primary outcome [1]
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Axillary temperature of the enrolled preterm or low birthweight neonates.
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Assessment method [1]
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Neonates axillary temperature will be recorded every thirty minutes using a mercury thermometer.
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Timepoint [1]
337508
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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
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Nil
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Timepoint [1]
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Nil
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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
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Minimum age
0
Hours
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Maximum age
72
Hours
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
7/12/2023
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Date of last participant enrolment
Anticipated
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Actual
29/03/2024
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Date of last data collection
Anticipated
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Actual
1/04/2024
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Sample size
Target
20
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Accrual to date
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Final
19
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Recruitment outside Australia
Country [1]
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Bangladesh
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State/province [1]
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Dhaka
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Ministry of Health and Family Welfare, Bangladesh
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Address [1]
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Country [1]
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Bangladesh
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Primary sponsor type
Other
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Name
International Centre for Diarrhoeal Disease Research, Bangladesh
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Address
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Country
Bangladesh
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Secondary sponsor category [1]
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None
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Name [1]
318068
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Address [1]
318068
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Country [1]
318068
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314761
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Ethical Review Committee (ERC)
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Ethics committee address [1]
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C/- IRB Secretariat, Research Administration, icdddr,b 68 Shaheed Tajuddin Ahmed Sarani (Mohakhali) Dhaka 1212, Bangladesh
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Ethics committee country [1]
314761
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Bangladesh
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Date submitted for ethics approval [1]
314761
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19/11/2022
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Approval date [1]
314761
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27/12/2022
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Ethics approval number [1]
314761
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Anisuddin Ahmed
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Address
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International Centre for Diarrhoeal Disease Research, Bangladesh, 68 Shaheed Tajuddin Ahmed Ave, Dhaka 1212
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Country
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Bangladesh
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Phone
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+8801755571024
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Anisuddin Ahmed
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Address
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International Centre for Diarrhoeal Disease Research, Bangladesh, 68 Shaheed Tajuddin Ahmed Ave, Dhaka 1212
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Country
132643
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Bangladesh
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Phone
132643
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+8801755571024
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Fax
132643
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Email
132643
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[email protected]
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Contact person for scientific queries
Name
132644
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Anisuddin Ahmed
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Address
132644
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International Centre for Diarrhoeal Disease Research, Bangladesh, 68 Shaheed Tajuddin Ahmed Ave, Dhaka 1212
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Country
132644
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Bangladesh
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Phone
132644
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+8801755571024
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Fax
132644
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Email
132644
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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