Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

Study Overview
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Brief Summary
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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
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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 If participants clinically deteriorate and meet stopping criteria they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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.

Official Title
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A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia

Conditions
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Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care, Infection, Bacterial

Intervention / Treatment
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* Other: Early Kangaroo Mother Care
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individually randomised controlled superiority trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early KMC<br>Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home | Other: Early Kangaroo Mother Care<br>* Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission<br>* Other names: Early kangaroo method;|
| Active Comparator: Standard care<br>Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home | Other: Standard care<br>* Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | All neonatal deaths within 28 postnatal days | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death | Time from start of intervention/control procedures to death | 28 days of age | 
| Cardio-respiratory Stability | The 'Stability of Cardio-Respiratory in Preterm' infants is a scale to quantify the cardio-respiratory stability of preterm infants. It is composed of three parameters: Heart rate; Respiratory rate and breathing pattern and oxygen saturation (including whether is in oxygen). Scores between 0 and 2 are allocated for each parameter, with minimum total score 0 and maximum total score 6. The highest score (6) represents a better outcome, with all parameters within normal range whilst not receiving oxygen. | At 24 hours after start of intervention/control procedures | 
| Number and Proportion of Participants With Hypothermia | Number and proportion of participants with hypothermia (Temperature <36.5 degrees Celsius) | At 24 hours after start of intervention/control procedures | 
| Weight Gain | Average daily weight gain compared to admission weight | At 28 days of age | 
| Exclusive Breastfeeding | Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation) | At time of hospital discharge, within study period, on average 2 weeks of age | 
| Suspected Infection Between 3d to 28d of Age | Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up | Within 28 days of age | 
| Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae | Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae | At day 28 of age | 
| Duration of Hospital Admission | Mean length of admission (first admission only if re-admitted) | Within 28 days of age or at latest follow-up |