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Clinical Trials/CTRI/2023/02/050027
CTRI/2023/02/050027CompletedPhase 4

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

Kasturba Medical College, MAHE1 site in 1 country182 target enrollmentStarted: January 3, 2023Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
182
Locations
1
Primary Endpoint
Rate of NICU admission for hypoglycemia.

Study Overview

Brief Summary

Neonatal hypoglycemia is one of the most common and readily preventable causes of adverse neurological sequelae and poor neurodevelopmental outcome. It is alarming to learn that neonatal hypoglycemia, affects as many as 5-15 % of otherwise healthy babies. This incidence is higher in resource poor countries6.Prevalence of the hypoglycemia is increasing due to increase in preterm births, small for gestation (SGA), and higher incidence of maternal diabetes. Despite this, the initial management still focuses on feeding and serial monitoring of blood glucose levels . The most recent AAP guidelines, recommended screening for 2 groups of neonates: term and late preterm neonates who are symptomatic and neonates whoare asymptomatic but have associated risk factors. The target is to achieve blood glucose values of 45 mg/dL (2.5 mmol/L) or greater prior to a feeding. Infants of diabetic mothers (IDMs) andlarge-for-gestational age (LGA) infants are screened for 12 hours after birth while SGA and preterm infants are screened for the first 24 hours. Symptomatic neonates with a blood glucose level <40mg/dl are shifted to the NICU and started on IV dextrose while at-risk asymptomatic newborns, less than 4 hours old with a blood glucose level less than 25 mg/) after a first feeding within 1 hour of birth are also started on IV dextrose. In asymptomatic at risk infants with glucose levels between 25-40 mg/dl, the infant can be fed again and blood glucose should be assessed 30 minutes after the feeding and IV dextrose is administered as needed. If the at-risk but asymptomatic newborn is 4 to 24 hours old and the blood glucose screening result is less than 35 mg/dL, feed should be administered every 2 to 3 hours, although IV glucose may be administered at this point as well. If the blood glucose measures 35 to 45 mg/dL, feeds may continue or IV glucose may be administered as needed. IAP follows similar guidelines as suggested by the AAP. PES recommends that within the first 48 hours of birth, infants with an inability to maintain blood glucose values greater than 50 mg/dL are at risk for persistent hypoglycemia, (a value greater than that suggested by the AAP ) and hence serial monitoring is needed for them. If blood glucose concentration continues to remain low the neonate is shifted to the NICU and started on intravenous glucose and fluids. ICU admissions warrant separation of mother and baby, thus delaying establishment of breast feeding and sustaining exclusive breast feeding .

In addition to intravenous glucose, 40% dextrose gel is upcoming novel treatment being used in well developed countries. . It is  applied onto the neonate’s buccal mucosa  to treat hypoglycemia. It is a relatively inexpensive, safe, and non-invasive way of treatment. It keeps mother and baby together while treatment is provided, decreasing separation time .

It is easy to administer and hence can be used in resource constraint set ups as a first line of treatment before referral to higher centres. This study will thus help us to find out the effectiveness and utility of dextrose gel in our hospital.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
0.00 Day(s) to 3.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • •All asymptomatic neonates, >35 weeks of gestation with hypoglycemia (blood glucose levels <50mg/dl) in the first 48 hours of life, admitted at Kasturba Hospital, Manipal with any of the following risk factors NEONATAL FACTORS Small for gestation (SGA) (Birth weight <10th centile or <2500g) 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

  • •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<6.8 or hypoxia with persistent bradycardia) 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.

Outcomes

Primary Outcomes

Rate of NICU admission for hypoglycemia.

Time Frame: Outcome will be assessed at the end of 48 hours from introduction into the trial.

Secondary Outcomes

  • Exclusive breast feeding established at discharge and at 6 weeks of age
  • Percentage of hypoglycemic episodes in neonates after administration of the gel
  • Incidence of recurrent hypoglycemia or hyperglycemia after dextrose gel application(Reduction in incidence of both)

Investigators

Sponsor
Kasturba Medical College, MAHE
Sponsor Class
Private medical college

Study Sites (1)

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