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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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