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CTRI Number  CTRI/2023/02/050027 [Registered on: 23/02/2023] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An open labelled randomised control trial where oral Dextrose (Glucose) Gel will be used for treatment of low blood sugar (hypoglycemia) in neonates. 
Scientific Title of Study   Oral Dextrose Gel for Treatment of Neonatal Hypoglycemia: An Open Labelled Randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruthi K Bharadwaj 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College and Hospital 
Address  Department of Neonatology, Women and Child Block,Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7338321832  
Fax    
Email  shruthi.kb@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Smriti Bhargava 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Hospital 
Address  Department of Pediatrics, Women and Child Block,Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535574829  
Fax    
Email  drsmritibhargava21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Smriti Bhargava 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Hospital 
Address  Department of Pediatrics, Women and Child Block,Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535574829  
Fax    
Email  drsmritibhargava21@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, MAHE, Madhav Nagar, Manipal 576104 
 
Primary Sponsor  
Name  Kasturba Medical College, MAHE 
Address  Kasturba Medical College, MAHE, Madhav Nagar, Manipal 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Smriti Bhargava  Department of Pediatrics, Kasturba Medical College and Hospital, Manipal  NICU, 1st floor, Women and Child Block, Kasturba Medical College and Hospital, Manipal, 576104
Udupi
KARNATAKA 
9535574829

drsmritibhargava21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P70||Transitory disorders of carbohydrate metabolism specific to newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 of administration if GRBS values are between 25mg/dl to 50mg/dl. Duration of intervention: Upto 48 hours. Please note: Up to 6 doses of gel can be given within 48 hours but not more than 4 doses can be given in 24 hours. 
Comparator Agent  Feeds only  The neonate is given breast milk and skin to skin contact. If feeding is poor, expressed breast milk or formula feeds according to birth weight are given by paladai and GRBS is repeated after 1 hour. Based on repeat blood glucose levels, treatment options are decided as below 1. Blood glucose levels 25 mg /dl: Neonate is shifted to NICU and started on IV dextrose 2. Blood glucose 50mg/dl: Continue oral feeds, skin to skin and serial monitoring 3. Blood glucose 25mg/dl but 50mg/dl: Give oral feeds, skin to skin and monitor GRBS after one hour of feed. If 3 consecutive blood glucose levels are 25mg/dl but 50mg/dl or neonate becomes symptomatic, the neonate is shifted to NICU and started on IV dextrose. If blood glucose 50mg/dl, continue oral feeds, skin to skin and serial monitoring 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  3.00 Day(s)
Gender  Both 
Details  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


 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of NICU admission for hypoglycemia.   Outcome will be assessed at the end of 48 hours from introduction into the trial. 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of hypoglycemic episodes in neonates after administration of the gel

 
Reduction in hypoglycemic episodes after gel administration 
Exclusive breast feeding established at discharge and at 6 weeks of age
 
Established  
Incidence of recurrent hypoglycemia or hyperglycemia after dextrose gel application  Reduction in incidence of both 
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
Final Enrollment numbers achieved (Total)= "193"
Final Enrollment numbers achieved (India)="193" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/03/2023 
Date of Study Completion (India) 30/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="25" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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 who

are 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) and

large-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.

 
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