| CTRI Number |
CTRI/2025/06/088196 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effects of early feeds fortification in preterm infants |
|
Scientific Title of Study
|
To evaluate the effects of early fortification of feeds on anthropometric parameters in preterm infants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin goyal |
| Designation |
Post graduate student |
| Affiliation |
SMS&R Sharda University Greater Noida |
| Address |
Pediatrics department Sharda university
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9716737502 |
| Fax |
|
| Email |
drgoyalsachin96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar Thapar |
| Designation |
HOD Professor |
| Affiliation |
SMS&R Sharda University Greater Noida |
| Address |
Pediatrics department Sharda university
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9839448248 |
| Fax |
|
| Email |
rajeev.thapar@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin goyal |
| Designation |
Post graduate student |
| Affiliation |
SMS&R Sharda University Greater Noida |
| Address |
Pediatrics department Sharda university
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9716737502 |
| Fax |
|
| Email |
drgoyalsachin96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharda Hospital Greater Noida UTTAR PRADESH INDIA 201306 |
|
|
Primary Sponsor
|
| Name |
Sharda University |
| Address |
SMS&R Sharda University Greater Noida UTTAR PRADESH INDIA 201306 |
| Type of Sponsor |
Private 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 Sachin |
Sharda Hospital |
Pediatrics department
Gautam Buddha Nagar
UTTAR PRADESH |
9716737502
drgoyalsachin96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sharda University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preterm neonate |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Early feeds fortification |
Standard fortification of feeds done till newborn started on breastfeeding |
| Intervention |
Early feeds fortification |
To evaluate the effects of early fortification of feeds vs standard fortification of feeds on anthropometric parameters in preterm infants till newborn started on breastfeeding |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All hemodynamically stable pre-term (less than 37weeks) admitted in NICU |
|
| ExclusionCriteria |
| Details |
Term neonates on breastfeeding
Neonates with co-morbidity hindering feeding |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate early feed fortification at 50ml/kg/day with standard fortification at 100ml/kg/day for gain in head circumference, weight gain, length gain of the baby |
Head circumference increase measured weekly
Weight gain measured twice weekly
Length gain measured weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the time at which baby attained birth weight |
Measured between day 7 to day 14 |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
16/06/2025 |
| 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="0"
Months="11"
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
|
I am going to conduct a Randomised control trial on Early fortification of feeds in pre-term infants admitted in NICU to study its effects on anthropometric parameters of preterm neonates. All pre-terms who are hemodynamically stable but not started on breastfeeding are involved in the study. Randomization was done using a computer generated sequence and effects of fortification on anthropometric parameters in preterm infants was measured between the two groups. |