Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03555981
• Date of registration: 08/05/2018
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates eKMC
• Scientific title: A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia
• Date of first enrolment: May 20, 2018
• Target sample size: 279
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03555981
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Gambia

Contacts

• Name: Helen C Brotherton, MBChB
• Affiliation: London School of Hygiene and Tropical Medicine

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 24 Hours
Gender: All

Health Condition(s) or Problem(s) studied

Infection, Bacterial

Kangaroo Mother Care

Preterm Infant

Death

Hypothermia, Newborn

Intervention(s)

Other: Early Kangaroo Mother Care

Other: Standard care

Primary Outcome(s)

All-cause mortality [Time Frame: 28 days]

Secondary Outcome(s)

Cardio-respiratory stability [Time Frame: At 24 hours after start of intervention/control procedures]

Neonatal intestinal carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella pneumoniae [Time Frame: At day 28 of age]

Duration of hospital admission [Time Frame: Within 28 days of age or at latest follow-up]

Exclusive breastfeeding [Time Frame: At time of hospital discharge, within study period, on average 2 weeks of age]

Weight gain [Time Frame: At 28 days of age]

Hypothermia [Time Frame: At 24 hours after start of intervention/control procedures]

Time to death [Time Frame: 28 days of age]

Suspected infection at >3 days of age (suspected late-onset infection) [Time Frame: Within 28 days of age]

Secondary ID(s)

14545

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical Research Council Unit, The Gambia

Wellcome Trust