Role of 40% oral dextrose gel on prevention of hypoglycemia in newborn Infants of Diabetic Mother (IDM) – A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Christian Medical College
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Incidence of hypoglycemia
Study Overview
Brief Summary
Infant of diabetic mother babies are more prone for hypoglycemia. Hypoglycemia causes neonatal morbidity and mortality. Few simple and low cost strategies such as early breast feeding, prolonged breast feeding for more than 20 minutes, frequent feeding every 2-3 hourly and strict thermoregulation in delivery room were studied and found that those interventions decrease the incidence of hypoglycemia in infant of diabetic mother babies and were accepted as standard of care. Recent research with 40% oral dextrose gel also had given promising results in reduction of incidence of hypoglycemia in at risk babies (IDM+SGA+preterm>35 weeks). We planned to study the add on beneficial effect of oral dextrose gel on prevention of hypoglycemia in infant of diabetic mother.
We plan a study with the aim of, "To study the prophylactic effect of 40% oral dextrose gel on prevention of neonatal hypoglycemia in infants of diabetic mother and to formulate a scoring system to predict the responder and non responder to 40% oral dextrose gel".
All mothers will be conselled for the importance of early, frequent & prolonged colostrum feeding. We will send the cord blood glucose and cord blood marker of high insulin level (C peptide) in Infant of diabetic mother (IDM ) babies. We will apply 200mg/kg of 40% oral dextrose gel within 30 minutes of life in study group followed by breast feeding and only breast feeding without gel in control group.
We will measure the blood glucose level in both the groups at 11/2 , 3, 5, 7, 12 , 18, 24 hour of life. We will measure the beneficial action of oral dextrose gel in the form of reduction in incidence of hypoglycemia, requirement of intravenous fluid, admission, not decrease the rate of exclusive breast feeding without causing any harm effect like hyperglycemia, late hypoglycemia and rebound hypoglycemia. We will try to formulate a scoring system to predict the responder and non responder to oral dextrose gel. Also we will find out few pharmacokinetic properties of 40% oral dextrose gel like onset of action, duration of action and rate of rise of blood glucose.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 0.00 Day(s) to 1.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Infant of diabetic mother more than 35 weeks of gestational age and more than 2 kg.
Exclusion Criteria
- •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).
- •No consent
- •Major congenital malformation.
Outcomes
Primary Outcomes
Incidence of hypoglycemia
Time Frame: in the first 24 hours after birth
Secondary Outcomes
- Incidence of Necrotizing Enterocolitis(till 24 hours of life)
- Incidence of sepsis without antenatal risk of sepsis(till discharge)
- Number Needed to Treat(till 24 hours of life)
- Compliance of care(till 24 hours of life)
- Maternal satisfaction(till discharge)
- Onset of action and duration of action of oral dextrose gel(till 24 hours of life)
- Rate of rise of glucose due to oral dextrose gel(till 24 hours of life)
- Rate of exclusive breast feeding up to 6 months of age(6 months of life)
- Reduction in admission rate due to hypoglycemia
- Formulation of scoring system to predict the responder and non-responder to oral dextrose gel based on following risk factors:(Type of maternal diabetes)
- Duration of hospital stay(within 28 days of life)
- Maximum requirement of Glucose Infusion Rate(till 24 hours of life)
- Incidence of rebound hypoglycemia(till 24 hours of life)
- Incidence of hyperglycemia(till 24 hours of life)
- Incidence of late hypoglycemia(till 24 hours of life)
- Rate of exclusive breast feeding till discharge determined by parental(Questionnaire)
- Incidence of feed intolerance(till 24 hours of life)