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Oral Dextrose Gel for Improving Blood Glucose Levels in At-Risk Newborn Babies

Optimizing Transitional Glucose Adaptation in At-Risk Neonates Using Oral Dextrose Gel: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202606595355917
Enrollment
100
Registered
2026-06-19
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases

Interventions

Oral Dextrose Gel
Standard Care

Sponsors

Minia University
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Achievement of euglycaemia at 120 minutes, defined as capillary blood glucose =45 mg/dL

Secondary

MeasureTime 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

Public ContactNagwa Mohamed Sabry Mahmoud

Faculty of Medicine Minia University

dr_nagwa163@mu.edu.eg00201022779294

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026