| CTRI Number |
CTRI/2024/07/070683 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Preterm milk and human milk fortifier] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
If preterm milk is not inferior to HMF as a preterm human milk fortifier |
|
Scientific Title of Study
|
Human Milk Fortifier VS Preterm milk for fortification of
Preterm Human Milk. A Non Inferiority Randomized
Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ammar haider |
| Designation |
DM Resident |
| Affiliation |
GMCH, aurangabad |
| Address |
Department of Neonatology, 2nd Floor, Government medical college, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8658222360 |
| Fax |
|
| Email |
haider263@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMOL JOSHI |
| Designation |
Associate Professor |
| Affiliation |
GMCH, aurangabad |
| Address |
Department of Neonatology, 2nd Floor, GMCH Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8658222360 |
| Fax |
|
| Email |
dramolkj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
ammar haider |
| Designation |
DM Resident |
| Affiliation |
GMCH, aurangabad |
| Address |
Department of Neonatology, 2nd Floor, Government medical college, Aurangabad.
Care of dr md israil, BABUNIA ROAD, SIWAN. bihar.
MAHARASHTRA
431001
India |
| Phone |
8658222360 |
| Fax |
|
| Email |
haider263@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ammar Haider |
Government medical college, Aurangabad |
Department Of Neonatology, Government medical college, Aurangabad, Jubilee Park, Aurangabad
Aurangabad
MAHARASHTRA |
8658222360
haider263@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College, Arangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R50-R69||General symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Human Milk Fortifier |
HMF 1 sachet in every 25ml of expressed breast milk every feed till baby is discharged |
| Intervention |
Preterm formula milk. |
Preterm formula milk 1gm in 20 ml expressed breast milk every feed till baby is discharged |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants with a gestational age less than 34
weeks admitted to the neonatal intensive care unit
(NICU).
Receiving EBM of 100ml/kg/day.
Give consent to be included in the study. |
|
| ExclusionCriteria |
| Details |
Preterm with major congenital anomalies
Neonates not receiving preterm human milk (LESS THAN 75%).
Preterm who is on Mechanical ventilation
Neonates requiring surgery. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know the efficacy of fortifying preterm human milk
with Preterm Formula Milk and Human Milk Fortifier in
terms of time achieved to attain birth weight. |
Till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the head circumference and length
To assess the complications like feed intolerance,
necrotizing enterocolitis. |
till discharge |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
01/08/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [haider263@gmail.com].
- For how long will this data be available start date provided 01-05-2024 and end date provided 05-12-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Human Milk Fortifier VS Preterm milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial. Primary objective: To know the efficacy of fortifying preterm human milk with Preterm Formula Milk and Human Milk Fortifier in terms of time achieved to attain birth weight. Secondary objectives: To assess the head circumference and length To assess the complications like feed intolerance, necrotizing enterocolitis. Inclusion Criteria: Preterm infants with a gestational age less than 34 weeks admitted to the neonatal intensive care unit (NICU). Receiving EBM of 100ml/kg/day. Give consent to be included in the study. Exclusion Criteria: 1. Preterm with major congenital anomalies 2. Neonates not receiving preterm human milk (<75%). 3. Preterm who is on Mechanical ventilation 4. Neonates requiring surgery. PRIMARY OBJECTIVES: To know the efficacy of fortifying preterm human milk with Preterm Formula Milk and Human Milk Fortifier in terms of time achieved to attain birth weight. 2.2 : SECONDARY OBJECTIVES: 1. To assess the head circumference and length 2. To assess the complications like feed intolerance, necrotizing enterocolitis |