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

Phase 4

Completed

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

Registration Number: CTRI/2023/02/050027

Lead Sponsor: Kasturba Medical College, MAHE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 193

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Exclusive breast feeding established at discharge and at 6 weeks of age <br/ ><br>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 <br/ ><br> <br/ ><br>Timepoint: Reduction in hypoglycemic episodes after gel administration