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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC...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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fajara, Western Division, Gambia
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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