| CTRI Number |
CTRI/2025/05/086518 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
TO STUDY THE ACYLCARNITINE AND AMINOACID PROFILE IN SMALL FOR GESTATIONAL AGE: TERM AND PRETERM NEONATES |
|
Scientific Title of Study
|
ACYLCARNITINE AND AMINOACID PROFILE IN SMALL FOR GESTATIONAL AGE: TERM AND PRETERM NEONATES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VARIKUTI CHERITHA REDDY |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
DEPARTMENT OF PEDIATRICS MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS,
MAULANA AZAD MEDICAL COLLEGE,
NEW DELHI
New Delhi
DELHI
110002
India |
| Phone |
8886044842 |
| Fax |
|
| Email |
cheritha1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SEEMA KAPOOR |
| Designation |
Director professor |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS,
MAULANA AZAD MEDICAL COLLEGE,
NEW DELHI
New Delhi
DELHI
110002
India |
| Phone |
011-23236031 |
| Fax |
|
| Email |
drseemakapoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VARIKUTI CHERITHA REDDY |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
DEPARTMENT OF PEDIATRICS MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS,
MAULANA AZAD MEDICAL COLLEGE,
NEW DELHI
New Delhi
DELHI
110002
India |
| Phone |
8886044842 |
| Fax |
|
| Email |
cheritha1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics,Maulana azad medical college |
|
|
Primary Sponsor
|
| Name |
Department of pediatrics |
| Address |
Maulana azad medical college,new delhi |
| 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 Varikuti Cheritha Reddy |
Lok Nayak hospital |
department of pediatrics and inborn unit of neonatology
maulana azad medical college and associated lok nayak hospital,
new delhi
New Delhi
DELHI |
8886044842
cheritha1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
small for gestational age: terms and preterm neonates |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
small for gestational age neonates born preterm and term |
|
| ExclusionCriteria |
| Details |
neonates on any parenteral nutrition
neonates on human milk fortifiers prior to enrollment
neonates with shock and on mechanical ventilation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
levels of acylcarnitines in term and preterm small for gestational ages babies with various gestational ages and birth weights
levels of aminoacids in term and preterm small for gestational ages babies with various gestational ages and birth weights.
Percentile charts from 0.5 to 99.5 th percentile across gestational ages and birth weights
|
small for gestational age term and preterm neonates at 24 plus 6hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="520"
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)
|
17/05/2025 |
| 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="0"
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
|
This study is a cross sectional analytical study to find the levels of acylcarnitine and aminoacid levels in small for gestational age term and preterm neonates around 260 in each group to be conducted in department of pediatrics maulana azad medical college New Delhi The primary outcome variables are to find levels of acylcarnitine and aminoacid levels in term and preterm small for gestational age neonates. The secondary outcome variables are to find percentile charts from 0.5 to 99.5 th percentile across gestational ages and birth weights and correlation of levels with both birth weight and gestational age. |