Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
- Conditions
- Preterm InfantDeathInfection, BacterialKangaroo Mother CareHypothermia, Newborn
- Interventions
- Other: Early Kangaroo Mother CareOther: Standard care
- Registration Number
- NCT03555981
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- 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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 279
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early KMC Early Kangaroo Mother Care 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 Standard care Standard care 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
- Primary Outcome Measures
Name Time Method All-cause Mortality 28 days All neonatal deaths within 28 postnatal days
- Secondary Outcome Measures
Name Time Method Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae At day 28 of age Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae
Duration of Hospital Admission Within 28 days of age or at latest follow-up Mean length of admission (first admission only if re-admitted)
Number and Proportion of Participants With Hypothermia At 24 hours after start of intervention/control procedures Number and proportion of participants with hypothermia (Temperature \<36.5 degrees Celsius)
Exclusive Breastfeeding At time of hospital discharge, within study period, on average 2 weeks of age Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation)
Time to Death 28 days of age Time from start of intervention/control procedures to death
Suspected Infection Between 3d to 28d of Age Within 28 days of age Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up
Cardio-respiratory Stability At 24 hours after start of intervention/control procedures 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.
Weight Gain At 28 days of age Average daily weight gain compared to admission weight
Trial Locations
- Locations (1)
MRC Unit The Gambia at LSHTM
🇬🇲Fajara, Western Division, Gambia