At a glance
ClinicalIndex Comparison Record- ✓Singleton or twin pregnancy
- ✓Birthweight ≥700g and ≤2000g
- ✓Chronological age 1–48 hours at screening
- ✓Alive at recruitment
- ✕Outborn (not born at trial hospitals)
- ✕Triplet or higher order multifetal pregnancy
- ✕Indication for KMC 'certain' (clinically well, receiving none of the supportive therapies)
- ✕Severe life-threatening instability: SpO₂ <88% on oxygen AND ≥1 of: respiratory rate <20 or >100 breaths/min, apnoea requiring bag-mask ventilation, HR <100 or >200 bpm
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The OMWaNA Study: Operationalising Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa: a Multi-site Randomised Controlled Trial to Examine Mortality Impact in Uganda
In Brief
A clinical study evaluating Kangaroo mother care and Standard care for Kangaroo Mother Care and 3 related conditions. Completed, enrolled 2,221 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
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