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Prevention of low blood sugar by 40% Oral Dextrose gel in newborn infant of diabetic mother

Role of 40% oral dextrose gel on prevention of hypoglycemia in newborn Infants of Diabetic Mother (IDM) â?? A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010645
Enrollment
600
Registered
2017-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Infant of diabetic mother more than 35 weeks of gestational age and more than 2 kg.

Interventions

Intervention1: 40% dextrose gel: 1.Strict thermoregulation in delivery room (NRP recommendation) 2.Apply oral dextrose gel 200mg/kg over buccal mucosa 3.Start Direct breast feeding (within 30 mins) 4.

Sponsors

Christian Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infant of diabetic mother more than 35 weeks of gestational age and more than 2 kg.

Exclusion criteria

Exclusion criteria: 1. Requiring admission before randomization (preterm neonates less the 35 weeks of gestational age, birth weight less than 2000 grams, respiratory distress, major lethal congenital malformation, antenatal ultrasound findings with absent/reversal of end diastolic mesenteric flow, Rh negative mother with DCT positive baby and indication suggested by consultants). 2. No consent 3. Major congenital malformation

Design outcomes

Primary

MeasureTime frame
Incidence of hypoglycemiaTimepoint: in the first 24 hours after birth

Secondary

MeasureTime frame
Number Needed to TreatTimepoint: till 24 hours of life;Onset of action and duration of action of oral dextrose gelTimepoint: till 24 hours of life;Compliance of careTimepoint: till 24 hours of life;Duration of hospital stayTimepoint: within 28 days of life;Incidence of feed intoleranceTimepoint: till 24 hours of life;Incidence of hyperglycemiaTimepoint: till 24 hours of life;Incidence of late hypoglycemiaTimepoint: till 24 hours of life;Incidence of Necrotizing EnterocolitisTimepoint: till 24 hours of life;Incidence of rebound hypoglycemiaTimepoint: till 24 hours of life;Incidence of sepsis without antenatal risk of sepsisTimepoint: till discharge;Maternal satisfactionTimepoint: till discharge;Maximum requirement of Glucose Infusion RateTimepoint: till 24 hours of life;Formulation of scoring system to predict the responder and non-responder to oral dextrose gel based on following risk factors: Type of maternal diabetes Uncontrolled maternal diabetes Placentomegaly cord blood glucose cord blood C peptide level rate of fall of blood glucose at one and half an hour SGA LGA macrosomia IUGR prematurity low birth weight PIH maternal use of beta blocker and dextrose containing IV fluids during labor cold stress hypothermiaTimepoint: one and half an hour of life;Rate of exclusive breast feeding till discharge determined by parental QuestionnaireTimepoint: till discharge;Rate of exclusive breast feeding up to 6 months of ageTimepoint: 6 months of life;Rate of rise of glucose due to oral dextrose gelTimepoint: till 24 hours of life;Reduction in admission rate due to hypoglycemia Timepoint: in the first 24 hours after birth

Countries

India

Contacts

Public ContactThanigainathan

Christian Medical College

thanigaipaeds@yahoo.com9176078520

Outcome results

None listed

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