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Search / Trial NCT03555981

Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

Launched by LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE · Jun 1, 2018

Trial Information

Current as of May 15, 2025

Terminated

Keywords

ClinConnect Summary

This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates \<2000g and aged \<24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at \<24h of admission) or standard care with continuous KMC at \>24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • New admission to study site during study period
  • Admission weight \<2000g
  • Age 1 - 24h at start of screening
  • Alive at enrolment
  • Availability of study bed
  • Written informed consent from parent or caregiver
  • Parent or caregiver available and willing to provide intervention, if necessary
  • Exclusion Criteria:
  • Congenital malformation incompatible with life or needing immediate surgical correction
  • Severe jaundice needing immediate management
  • Seizures
  • Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring
  • Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring
  • Completed triplet admission
  • Mother and/or neonate enrolled in another research study at time of hospital admission

About London School Of Hygiene And Tropical Medicine

The London School of Hygiene and Tropical Medicine (LSHTM) is a prestigious research institution renowned for its leadership in global health and infectious disease research. Committed to advancing public health through innovative research and education, LSHTM conducts a wide array of clinical trials aimed at improving health outcomes in diverse populations. With a multidisciplinary team of experts, LSHTM leverages cutting-edge methodologies and collaborative partnerships to address pressing health challenges, particularly in low- and middle-income countries. The institution's dedication to evidence-based solutions underscores its pivotal role in shaping health policies and practices worldwide.

Locations

Fajara, Western Division, Gambia

Patients applied

0 patients applied

Trial Officials

Helen C Brotherton, MBChB

Principal Investigator

London School of Hygiene and Tropical Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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