Digestive System Neonatal Diseases Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
Early OPBM
Placebo Control
LATE OPBM
Sponsors
Kampala International University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Gestational age 28–32 completed weeks • Inborn neonates delivered at JRRH or KRRH • Age 0–24 hours at enrollment • Clinically stable for OPBM administration • Written informed consent will be obtained from mother/legal guardian
Exclusion criteria
Exclusion criteria: • Major congenital anomalies • Severe hypoxic-ischemic encephalopathy (Grade III) • Outborn neonates • Neonates requiring immediate surgical intervention • Mothers unable to provide breast milk • Refusal or withdrawal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Time to full enteral feeding Defined as the number of days from birth to achievement of 150 ml/kg/day enteral intake maintained for =48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| • Feeding intolerance • Time to regain birth weight • Late-onset neonatal sepsis • Need and duration of respiratory support • Incidence of necrotizing enterocolitis • Length of NICU stay • Neonatal mortality (descriptive) | — |
Countries
Uganda
Contacts
Public ContactBERNIS MAREN Melvis
Kampala International University Western Campus
Outcome results
None listed