Clinical trial NCT03555981: Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
Official title: A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Infant
Hypothermia, Newborn
Death
Kangaroo Mother Care
Infection, Bacterial
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Medical Research Council Unit, The Gambia
First posted: 2018-06-14
Enrollment: 279
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individually randomised controlled superiority trial
Primary purpose: TREATMENT

Brief summary: The mortality effect of kangaroo mother care in stable newborns \<2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates \<2000g in a resource limited hospital setting.

Detailed description: 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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms.

Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.

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

Primary outcomes:
measure: All-cause Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Time to Death
timeFrame: 28 days of age
measure: Cardio-respiratory Stability
timeFrame: At 24 hours after start of intervention/control procedures
measure: Number and Proportion of Participants With Hypothermia
timeFrame: At 24 hours after start of intervention/control procedures
measure: Weight Gain
timeFrame: At 28 days of age
measure: Exclusive Breastfeeding
timeFrame: At time of hospital discharge, within study period, on average 2 weeks of age
measure: Suspected Infection Between 3d to 28d of Age
timeFrame: Within 28 days of age
measure: Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae
timeFrame: At day 28 of age
measure: Duration of Hospital Admission
timeFrame: Within 28 days of age or at latest follow-up
Other outcomes:
Locations:
city: Fajara
country: Gambia
facility: MRC Unit The Gambia at LSHTM
state: Western Division
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Helen C Brotherton, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brotherton H, Gai A, Kebbeh B, Njie Y, Walker G, Muhammad AK, Darboe S, Jallow M, Ceesay B, Samateh AL, Tann CJ, Cousens S, Roca A, Lawn JE. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial. EClinicalMedicine. 2021 Aug 6;39:101050. doi: 10.1016/j.eclinm.2021.101050. eCollection 2021 Sep.
citation: Brotherton H, Gai A, Tann CJ, Samateh AL, Seale AC, Zaman SMA, Cousens S, Roca A, Lawn JE. Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC). Trials. 2020 Mar 6;21(1):247. doi: 10.1186/s13063-020-4149-y.