Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
Condition: Kangaroo Mother Care; Preterm Infant; Death; Neonatal; Hypothermia, Newborn
MeSH terms: Hypothermia; Birth Weight
Study type: Interventional

Summary: 
      We will conduct an individually randomised, controlled, superiority trial with two parallel
      groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard'
      care. The primary aim is to examine the impact of KMC initiated before stabilisation on
      mortality within 7 days relative to standard care amongst neonates ≤2000g at four hospitals
      in Uganda. We hypothesise that neonates in the arm allocated to receive KMC before
      stabilisation will have a 25% overall reduction in mortality within 7 days compared to
      neonates allocated to receive standard care.
    

Detailed description: 
      METHODS Study setting, design, and participants The OMWaNA trial was an individually
      randomised, controlled, superiority trial with two parallel arms allocated in a 1:1 ratio to
      receive KMC initiated before stabilisation (intervention) or standard care (control). The
      trial was conducted in the neonatal units (WHO level-2) of five government hospitals in
      Uganda (appendix p 5). Infrastructure and equipment improvements as well as training were
      required prior to trial initiation, as described previously.10 All hospitals were provided
      with essential equipment and supplies to support the provision of KMC and level-2 newborn
      care. Details regarding study context and methods have been published in the trial protocol9
      and are briefly summarised here. Ugandan practice is that maternity and newborn care should
      be provided free of charge in government health facilities;11 however, families are expected
      to support caregivers to meet essential needs such as meals.

      The trial is reported here in accordance with the CONSORT guidelines. All live-born neonates,
      aged 1 to <48 hours and weighing 700-2000g, who were admitted to participating hospitals and
      for whom the indication for KMC was "uncertain" according to WHO guidance concerning clinical
      stability, defined as receiving ≥1 therapy (oxygen, continuous positive airway pressure
      [CPAP] where available, intravenous [IV] fluids, therapeutic antibiotics, anti-seizure
      medication), were eligible for inclusion. Exclusion criteria included triplet or higher
      multi-fetal pregnancy (unless pregnancy resulted in demise of ≥1 fetus) and parent/caregiver
      being unable/unwilling to provide either consent, KMC, and/or attend follow-up visits.
      Neonates with life-threatening instability, severe jaundice requiring immediate management,
      active seizures, or major congenital malformations were also excluded. The study was approved
      by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717),
      Uganda National Council of Science and Technology (HS 2645), and London School of Hygiene &
      Tropical Medicine (LSHTM, 16972). The trial was overseen by a steering committee and an
      independent data and safety monitoring board (DSMB).

      Screening and informed consent All admitted neonates weighing ≤2000g were screened for
      eligibility by study staff. Stable neonates (meeting WHO 2019 criteria for KMC eligibility)
      were excluded and remaining neonates were assessed for eligibility. Those who met criteria
      for 'life-threatening instability' or who had conditions precluding KMC (e.g., seizures,
      jaundice), were reassessed every 3 hours up to 48 hours, after which they were excluded.
      Written informed parental consent was obtained for all participants.

      Randomisation, allocation concealment and masking A random allocation sequence was
      computer-generated using permuted blocks of varying sizes stratified by birthweight (<1000g,
      1000-1499g, ≥1500g) and recruitment site. Allocation concealment was done by programming the
      allocation sequence into the screening database and revealing treatment group only when
      screening of eligible neonates was complete. Neonates from multiple births (twins or
      triplets) were allocated to the same arm according to first-born allocation.14 Masking of
      parents, caregivers, or healthcare workers was not possible due to the nature of the KMC
      intervention.

      Procedures In the intervention arm, KMC was initiated soon after randomisation. Neonates were
      naked except for hat and diaper, placed prone and skin-to-skin on caregiver's chest, and
      secured using a KMC wrap. Adjustable beds were provided to facilitate continuous skin-to-skin
      care. KMC duration was charted by caregivers and verified by study staff. When not in KMC
      (e.g., during maternal bathing), incubator or radiant heater care was commenced. Study
      personnel, in addition to hospital staff, provided continuous KMC counselling throughout the
      hospitalisation. Control arm neonates were cared for in an incubator or radiant heater, as
      per hospital practice. Caregivers could have physical contact with their newborn but
      skin-to-skin contact was not initiated until stability criteria were met.9 Once stable,
      newborns were transferred to routine (intermittent) KMC. Neonates in both arms received
      standard clinical care according to hospital guidelines.
    

Intervention name(s): Kangaroo mother care; Standard care
Intervention type(s): Other; Other
Intervention description(s): Skin-to-skin care (target: at least 18 hours per day); Incubator or radiant warmer until neonate meets stability criteria; once stable (WHO indication for KMC certain), the baby can transition to routine (intermittent) KMC
Other intervention name(s): Skin-to-skin care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kangaroo mother care; Preterm; Low birthweight; Neonatal; Newborn; Randomised trial