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Oral glucose solution for the treatment of neonatal hypoglycemia

Effectiveness of oral glucose solution for the treatment of neonatal hypoglycemia, a randomized, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181204005
Enrollment
400
Registered
2018-12-04
Start date
2018-12-05
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

postnatal hypoglycemia in late preterm and term infants neonatal hypoglycemia oral glucose solution asymptomatic hypoglycemia

Interventions

D50W 0.4 mL/kg (200 mg/kg glucose) slowly giving orally within 1-2 minutes and follow by oral feeding,Sterile water 0.4 mL/kg (200 mg/kg glucose) slowly giving orally within 1-2 minutes and follow by
Active Comparator Drug,Placebo Comparator Drug
Oral glucose,Placebo

Sponsors

The Siriraj Research Development Fund (Managed by Routine to Research: R2R).
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 48 Hours

Inclusion criteria

Inclusion criteria: 1. At least 34-week's GA 2. At least 1 risk factor of postnatal hypoglycemia (preterm, maternal diabetes, SGA, LGA, birthweight less than 2500g or more than 4000g) 3. Asymtomatic hypoglycemia 4. Age less than 48 hours 5. No contraindication of oral feedings 6. Parental written consent

Exclusion criteria

Exclusion criteria: 1. Blood glucose less than 25 mg/dL 2. IV fluid is indicated from other reasons 3. Major anomalies

Design outcomes

Primary

MeasureTime frame
proportion of infants require IV glucose administration within 48 hours present of having IV fluid for glucose admistration

Secondary

MeasureTime frame
incidence of hyperglycemia during 48 hours number of infants in each arm who have blood glucose >180 mg/dL,days of full enteral feedings during birth hospitalization postnatal days at reaching enteral feeding

Countries

Thailand

Contacts

Public ContactRatchada Kitsommart

Faculty of Medicine Siriraj Hospital

rkitsommart@hotmail.com66860666860

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026