| CTRI Number |
CTRI/2024/03/064726 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Prevention of neonatal hypoglycemias with oral dextrose gel among high-risk neonates admitted in Tertiary care centre |
|
Scientific Title of Study
|
Prevention of neonatal hypoglycemias with oral dextrose gel among high-risk neonates admitted in Tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrUthayashree P |
| Designation |
post graduate student |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Pediatric department, Gulbarga institute of medical sciences, kalaburagi
Kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
9345082007 |
| Fax |
|
| Email |
udhayshripandurangan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Revanasiddappa Bhosgi |
| Designation |
Professor and HOD |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Pediatric department, Gulbarga institute of medical sciences, kalaburagi
Kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
9900424220 |
| Fax |
|
| Email |
pediatricgims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrUthayashree P |
| Designation |
post graduate student |
| Affiliation |
Gulbarga institute of medical sciences |
| Address |
Pediatric department, Gulbarga institute of medical sciences, kalaburagi
Kalaburagi
KARNATAKA
585105
India |
| Phone |
9345082007 |
| Fax |
|
| Email |
udhayshripandurangan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Uthayashree P |
| Address |
pediatric department, Gulbarga institute of medial sciences, Kalaburagi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRREVANASIDDAPPA BHOSGI |
NICU, Gulbarga institue of medical sciences |
Gulbarga institute of medical sciences, Kalaburagi
Gulbarga
KARNATAKA |
9900424220
pediatricgims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Gulbarga institute of medical sciences, Kalaburagi |
Approved |
| Gulbarga institute of medicalsviences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P968||Other specified conditions originating in the perinatal period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
oral dextrose gel |
200 mg/kg (0.5ml/kg) of oral 40% dextrose gel taken in a 2 ml syringe and administered into the buccal cavity at birth and capillary blood glucose levels checked every 6th hourly using a bedside glucometer |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
preterm, small for gestational age, large for gestational age, infants of diabetic mothers |
|
| ExclusionCriteria |
| Details |
sepsis, endocrine causes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevention of hypoglycemia among high risk neonates |
every 6th hourly for 72 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EARLY DISCHARGE RATE |
1 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Glucose is the principal substrate for cerebral metabolism, and neonatal hypoglycemia causes damage in neuroglial cells and leads to adverse neurodevelopmental outcome.Approximately 25% of neonates are at risk for neonatal hypoglycemia. Some of these infants fail to normalize blood glucose levels by feed alone and require intravenous dextrose therapy. Preterm infants, small for gestational age (SGA), large for gestational age (LGA), infants of diabetic mothers are at high risk of requiring intravenous dextrose therapy due to persistent hypoglycemia. In this study, we aim to study about the use of oral dextrose gel (40%) in preventing hypoglycemia in at risk neonates which helps in better neurodevelopmental outcome and the use of oral dextrose gel in preventing hospital admission and early initiation of breastfeeding |