| CTRI Number |
CTRI/2024/10/075823 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two types of powders (plant based versus cow based) which are meant for increasing the proteins and calories of mothers milk in babies who are born prematurely |
|
Scientific Title of Study
|
Bovine derived versus plant based human milk fortification in preterm infants of less than 30 weeks gestation An open labelled multi-center randomized controlled trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Kumar M |
| Designation |
DrNB Neonatology resident |
| Affiliation |
Ankura hospital for women and children |
| Address |
Ankura Hospital for Women and Children, NICU, 3rd floor, Pillar No- 788, Bagh Ameer, Sumithra Nagar Colony, Kukatpally, Hyderabad
Hyderabad
TELANGANA
500072
India |
| Phone |
7204175425 |
| Fax |
|
| Email |
mudmalnik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vira Raghavan V R |
| Designation |
Consultant Neonatologist |
| Affiliation |
Ankura Hospital for Women and Children |
| Address |
Ankura Hospital for Women and Children, NICU, 3rd floor, Pillar No- 788, Bagh Ameer, Sumithra Nagar Colony, Kukatpally, Hyderabad
Hyderabad
TELANGANA
500072
India |
| Phone |
7204175425 |
| Fax |
|
| Email |
19.vira@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Kumar M |
| Designation |
DrNB Neonatology resident |
| Affiliation |
Ankura hospital for women and children |
| Address |
Ankura Hospital for Women and Children, NICU, 3rd floor, Pillar No- 788, Bagh Ameer, Sumithra Nagar Colony, Kukatpally, Hyderabad
Hyderabad
TELANGANA
500072
India |
| Phone |
7204175425 |
| Fax |
|
| Email |
mudmalnik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ankura Hospital for Women and Children, NICU, 3rd floor, Pillar No- 788, Bagh Ameer, Sumithra Nagar Colony, Kukatpally, Hyderabad- 500072, Telangana, INDIA |
|
|
Primary Sponsor
|
| Name |
Nikhil Kumar M |
| Address |
Ankura Hospital for Women and Children, NICU, 3rd floor, Pillar No- 788, Bagh Ameer, Sumithra Nagar Colony, Kukatpally, Hyderabad- 500072, Telangana, INDIA |
| 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 |
| Dr Nikhil Kumar M |
Ankura hospital for women and children |
Ankura Hospital for Women and Children, NICU, 3rd floor, Pillar No- 788, Bagh Ameer, Sumithra Nagar Colony, Kukatpally, Hyderabad
Hyderabad
TELANGANA |
7204175425
mudmalnik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ankura Ethics Committee Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preterm neonates admitted to NICU |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bovine based human milk fortifier |
Bovine based human milk fortifier 1 gram will be mixed in every 25 ml of mothers own milk or pasteurised donor human milk. Fortification will be done till 40 weeks PMA. |
| Intervention |
Plant based human milk fortifier |
Plant based human milk fortifier 1 gram will be mixed in every 25 ml of mothers own milk or pasteurised donor human milk. fortification will be done till 40 weeks PMA. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
preterm neonates who are started on mothers own milk or pasteurised donor human milk within 48hours of life and total parenteral nutrition within 6 hours of life. |
|
| ExclusionCriteria |
| Details |
1. preterm neonates with gross congenital anomalies
2. preterm neonates whose caretakers refuse to give consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time to reach enteral feed volume of 180ml per kg per day, rate of weight gain, head circumference increment and length increment |
at discharge and at 40weeks PMA. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of feed intolerance defined as necessity to keep the neonate nil by mouth for at least 1 day
NEC stage more than or equal to 2 Modified Bells’ staging
Combined outcome of NEC stage more than or equal to 2 or mortality
All-cause mortality
Probable sepsis with more than or equal to 2 serum parameters CRP more than 10mg per L, TLC less than 5000 or more than 25000cells per mm3, ANC as per charts or Procalcitonin more than 0.1ng per ml
Blood culture proven sepsis beyond 72hours
BPD defined as oxygen requirement or any other form of respiratory support at 36 weeks
ROP requiring intervention.
Osteopenia of prematurity defined as impaired bone mineralization with ALP more than 900IU per L, Serum Phosphorus less than 5.5mg per dl
Extra uterine growth restriction defined as to an inadequate growth that occurs during hospitalization weight less than 10th centile at 36weeks PMA. |
enteral feeds started within 48 hours of life and TPN started within 6 hours of life. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/11/2024 |
| 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)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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 will be conducted in level III NICU, from August 2024 to October 2025 in neonates born <30 weeks of gestation, meeting the inclusion criteria. After obtaining consent, the neonate will be assigned into group either fortification of EBM with bovine or plant based HMF after randomization. Baseline information and anthropometric measurements will be recorded at enrolment and every week. Fortification will be continued till the neonate reaches 2 kg or reaches 40 weeks PMA, whichever is earlier. The time taken to reach 180ml/kg feeds, incidence of NEC and death will be recorded until fortification is done. |