| 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 |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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An open labelled randomised control trial where oral Dextrose (Glucose) Gel will be used for treatment of low blood sugar (hypoglycemia) in neonates. |
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Scientific Title of Study
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Oral Dextrose Gel for Treatment of Neonatal Hypoglycemia: An Open Labelled Randomised Control Trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
|
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Source of Monetary or Material Support
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| Kasturba Medical College, MAHE, Madhav Nagar, Manipal 576104 |
|
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Primary Sponsor
|
| Name |
Kasturba Medical College, MAHE |
| Address |
Kasturba Medical College, MAHE, Madhav Nagar, Manipal 576104 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P70||Transitory disorders of carbohydrate metabolism specific to newborn, |
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Intervention / Comparator Agent
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| 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 |
|
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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
|
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| 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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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. |
|
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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 |
|
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Target Sample Size
|
Total Sample Size="182" Sample Size from India="182"
Final Enrollment numbers achieved (Total)= "193"
Final Enrollment numbers achieved (India)="193" |
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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 |
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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 |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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