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Effectiveness Trial of Thermal Jacket

NCT06277869 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-03-07

No results posted yet for this study

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

Interventions

DEVICE

Thermal Jacket

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

PROCEDURE

Kangaroo Mother Care

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

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    collaborator OTHER

  • Directorate General of Health Services (DGHS), Bangladesh

    collaborator UNKNOWN

  • Poeticgem International Ltd

    collaborator UNKNOWN

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Anisuddin Ahmed, MS · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-12-22
Completion
2024-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06277869 on ClinicalTrials.gov