Effectiveness Trial of Thermal Jacket

NCT06277869 | Recruiting Phase 2 DMC

• 1 other identifier: PR-22146
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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 Kangaroo Mother Care (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 low birthweight (LBW) neonates warm during transportation. The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings. Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh. Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh.

Conditions

Preterm Neonate; Low Birthweight Neonate

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Body temperature of preterm or low birthweight neonates maintain the euthermic range.

  The primary outcome of this phase is attainment and maintenance of euthermia, defined as i. Having reached to 36.5⁰ C for hypothermic neonates at any point of a single event, ii. Maintaining euthermia throughout the event and iii. Having risen the temperature up to the euthermic range within 1 hour if at any point neonate goes below euthermic range. The endpoint of each event will be ascertained for every neonate during the pre-phase and intervention-phase in the same manner regardless of whether the thermal jacket is used.

  6 hours per event

Study Arms (2)

Thermal Jacket

EXPERIMENTAL

As a intervention, the enrolled preterm or low birthweight neonates gets the thermal jacket as well as Kangaroo Mother Care for thermal care.

Device: Thermal Jacket; Procedure: Kangaroo Mother Care

Kangaroo Mother Care

ACTIVE COMPARATOR

As a control, the enrolled preterm or low birthweight neonates gets the conventional Kangaroo Mother Care only.

Procedure: Kangaroo Mother Care

Interventions

Thermal Jacket DEVICE

In the intervention group, the enrolled preterm or low birthweight eligible neonates gets the intervention Thermal Jacket as well as Kangaroo Mother Care.

Thermal Jacket

Kangaroo Mother Care PROCEDURE

Skin-to-Skin care, provided by primary caregiver.

Kangaroo Mother Care; Thermal Jacket

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• KMC eligible neonates
• Heart rate 100-160 per minute
• Capillary Refill Time ≤ 3 sec
• Respiratory rate 30-59 per minute
• Breaths comfortable
• Pink in room air

You may not qualify if:

• In nasogastric tube
• In oxygen therapy
• In intravenous fluid
• Sign of respiratory distress
• Prolonged or frequent apnea
• Major surgical problem
• Gross congenital anomaly

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

Study Sites (3)

Lakshmipur District Hospital

Lakshmīpur, Chattogram, 3700, Bangladesh

RECRUITING

Kushtia 250 Bedded General Hospital

Kushtia, Khulna Division, 7000, Bangladesh

RECRUITING

Jamalpur 250 Beded General Hospital

Jamālpur, Mymensingh, 2000, Bangladesh

NOT YET RECRUITING

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anisuddin Ahmed, MS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anisuddin Ahmed, MS

CONTACT

+8801755571024; anisuddin@icddrb.org

M.A Salam Khan, MS

CONTACT

88029886498; salamk@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomised trial

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

BA (3)