| CTRI Number |
CTRI/2024/09/073714 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [dextrose gel] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sugar Gel application for prevention of hypoglycemia in small babies |
|
Scientific Title of Study
|
Oral dextrose gel for prevention of hypoglycemia in small for gestation age neonates A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raashi |
| Designation |
Senior resident |
| Affiliation |
Government medical college |
| Address |
Neonatology department, Area 11, Government medical college, sector 32, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9205658084 |
| Fax |
|
| Email |
drrashisingh04@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Chawla |
| Designation |
Professor, Head of department |
| Affiliation |
Government medical college |
| Address |
Neonatology Department, B block 4th floor, Government medical college, sector 32, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
09646121559 |
| Fax |
|
| Email |
drdeepak.chawla@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Raashi |
| Designation |
Senior resident |
| Affiliation |
Government medical college |
| Address |
Department of neonatology, Government medical college hospital, Sector 32
Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9205658084 |
| Fax |
|
| Email |
drrashisingh04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital, Chandigarh 160030 |
|
|
Primary Sponsor
|
| Name |
Government medical college |
| Address |
Government medical college, Sector 32, Chandigarh 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Raashi |
Government medical college and hospital, |
B block ,4th floor, Department of Neonatology, Government medical college and Hospital 32, Chandigarh Chandigarh CHANDIGARH |
9205658084
drrashisingh04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Government Medical College and Hospital, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Small for gestation babies on full feed by 2 hours of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dextrose gel application |
Application of dextrose gel every six hourly for 72 hours on buccal mucosa in SGA babies for prevention of hypoglycemia. |
| Comparator Agent |
placebo(saline) |
SGA baby in comparator arm will be applied placebo on buccal mucosa and feeding will be initiated within 2 HOL. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Small for gestational age
Gestation at birth more than equal to 32 wk
Birth weight more than equal to 1200g and less than 2500g
On full enteral feed by 2 hr of age
|
|
| ExclusionCriteria |
| Details |
Major congenital malformation
Refuse of consent to participate by parents |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypoglycemia |
At 2 hour of life and then every six hourly for 72 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Proportion of time spent in hypoglycemia and hyperglycemia
2 Episode of time spent in hypolycemia and hyperglycemia
3 Need and duraTION OF iv fluid
4 Exclusive breast feeding rate |
first 72 hour of life -continuous glucose monitoring
(1-3)
At discharge and at 6 wk |
|
|
Target Sample Size
|
Total Sample Size="176" Sample Size from India="176"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The title of the study is oral dextrose gel for prevention of hypoglycemia in small for gestation age- A randomized controlled trial. The study will be an open label parallel group randomized control trial and will take place in the department of neonatology at government medical college, Chandigarh. The aim of the study is to evaluate the efficacy of oral dextrose gel administration in reducing incidence of hypoglycemia and incidence of breastfeeding rate at 6week of age. We will enrol 88 neonates in each limb, fulfilling the following inclusion criteria- Small for gestation age (less than 10 centile) , Gestation at birth equal to more than 32wk, birth weight equal to or more than 1200 g and less than 2500g and full enteral feed by 2hour of age. Babies with major congenital malformation and skin infection will be excluded. After obtaining consent, eligible neonate will be enrolled and randomly assigned to dextrose gel or control group. Randomization will be done as soon as clinical care team decide baby to be on full feed. Computer generated random sequence with permuted block of various sizes will be generated and placed in serially opaque number. Neonates randomized to dextrose gel group will be administered 200mg/kg of oral dextrose gel. Enteral feeding will be initiated within one hour of birth. The first dose of dextrose gel will be administered within 1hour of birth and repeat dose will be given every 12 hours till 72 hour of age. Neonate randomized to control group will be given saline placebo. At the time of randomization, continuous glucose monitoring sensor will be inserted in both group for 72 hours of age. the data of cgm sensor will be extracted at end of 72 hours of age. The outcome of the study will be incidence of hypoglycemia will be monitored at 2hr, 6hr and then every 6hr for first 72 hours after birth by glucometer. Other outcome- proportion of time spent in hypoglycemia and hyperglycemia by CGM. The need and duration of intravenous fluid from patient record .and exclusive breast feeding rate at discharge and at 6 week of age by interviewing the mother or telephonically. |