Neonatal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Clinically stable neonates Age =7 days at enrolment Gestational age =34 weeks At least one recognised risk factor for neonatal hypoglycaemia Infant of diabetic mother Intrauterine growth restriction Small-for-gestational-age status Large-for-gestational-age status Prematurity <37 weeks Perinatal stress, including birth asphyxia, meconium-stained amniotic fluid, or respiratory distress
Exclusion criteria
Exclusion criteria: Major congenital anomalies Chromosomal abnormalities Suspected inborn errors of metabolism Confirmed or suspected neonatal sepsis Significant congenital heart disease Persistent feeding intolerance Haemodynamic instability Requirement for immediate intravenous glucose therapy at presentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of euglycaemia at 120 minutes, defined as capillary blood glucose =45 mg/dL | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean capillary blood glucose level over time;Requirement for intravenous dextrose escalation ;Time to achievement of euglycaemia ;Euglycaemia response according to intrauterine growth restriction status ;Short-term adverse events, including aspiration, vomiting, apnoea, feeding intolerance, allergic reaction, and clinically significant hyperglycaemia | — |
Countries
Egypt
Contacts
Faculty of Medicine Minia University