An open labelled randomised control trial where oral Dextrose (Glucose) Gel will be used for treatment of low blood sugar (hypoglycemia) in neonates.

Oral Dextrose Gel for Treatment of Neonatal Hypoglycemia: An Open Labelled Randomised Control Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/050027

Enrollment

182

Registered

2023-02-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: P70- Transitory disorders of carbohydrate metabolism specific to newborn

Interventions

Intervention1: 40 % dextrose gel: Route of administration: 40% dextrose gel will be applied on the buccal mucosa. Dose: 200mg/kg or 0.5ml/kg PER dose. T Frequency: The gel can be repeated after 1 hour

Eligibility

Inclusion criteria

Inclusion criteria: All asymptomatic neonates, >35 weeks of gestation with hypoglycemia (blood glucose levels NEONATAL FACTORS Small for gestation (SGA) (Birth weight Large for gestation (LGA) (Birthweight >90th centile or >4000g) Intrauterine growth restriction (IUGR) Discordant twin : Weight 20% less than the larger twin Late preterm (35-36 weeks) Poor feeding Hypothermia MATERNAL FACTORS IDM : Gestational DM, Type 1 DM or Type 2 DM Maternal hypertension treated with Beta blockers Maternal Pre-eclampsia Maternal Eclampsia

Exclusion criteria

Exclusion criteria: 1.Neonates with: i.Any high-risk neonate admitted to NICU for any other reason ii.Perinatal asphyxia iii.Early onset sepsis iv.Critically ill neonates (pH v.Chromosomal disorders vi.Congenital malformations vii.Surgical conditions –like intestinal obstruction/perforation needing stoma and mucus fistula viii.Neonates with congenital or maternal infections 2.Parents who deny consent

Design outcomes

Primary

Measure	Time frame
Rate of NICU admission for hypoglycemia.Timepoint: Outcome will be assessed at the end of 48 hours from introduction into the trial.	—

Secondary

Measure	Time frame
Exclusive breast feeding established at discharge and at 6 weeks of age Timepoint: Established;Incidence of recurrent hypoglycemia or hyperglycemia after dextrose gel applicationTimepoint: Reduction in incidence of both;Percentage of hypoglycemic episodes in neonates after administration of the gel Timepoint: Reduction in hypoglycemic episodes after gel administration	—

Countries

India

Contacts

Public ContactSmriti Bhargava

Kasturba Medical College and Hospital

drsmritibhargava21@gmail.com9535574829

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026