| CTRI Number |
CTRI/2024/10/076032 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing amino acid based and bovine milk based human milk fortifiers for growth in babies with very low birth: A Clinical Trial |
|
Scientific Title of Study
|
Comparison of efficacy of amino acid based human milk fortifier versus bovine milk derived human milk fortifier in very low birth weight neonates: A single Centre open label 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 |
Dr Nishant Banait |
| Designation |
Associate Proffesor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of neonatology, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9673998494 |
| Fax |
|
| Email |
nishantbanait@aiimsnagpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit jaisinh Chauhan |
| Designation |
SR ACADEMIC DM NEONATOLOGY RESIDENT |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of neonatology, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9643900490 |
| Fax |
|
| Email |
ankitchauhan@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit jaisinh Chauhan |
| Designation |
SR ACADEMIC DM NEONATOLOGY RESIDENT |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of neonatology, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9643900490 |
| Fax |
|
| Email |
ankitchauhan@aiimsnagpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences Nagpur, Plot No. 2, Sector - 20, MIHAN, Nagpur, Maharashtra, Pin: 441108 |
|
|
Primary Sponsor
|
| Name |
Dr Nishant Banait |
| Address |
Department of neonatology ,All India Institute Of Medical Sciences Nagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ankit Jaisinh Chauhan |
Department of neonatology ,All India Institute Of Medical Sciences Nagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankit jaisinh Chauhan |
All India Institute Of Medical Sciences Nagpur |
IPD 303, NICU, Department of neonatology ,All India Institute Of Medical Sciences Nagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA |
9643900490
ankitchauhan@aiimsnagpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute Of Medical Sciences NagpurInstitutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P071||Other low birth weight newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amino acid based human milk fortifier (AA-HMF) |
Babies will be started on amino acid based human milk fortifier in ratio of 1 HMF sachet in 25 ML of milk or will be added in proportionate quantity on the basis of available quantity of milk till baby reach 1800 gram of weight. |
| Comparator Agent |
Bovine milk based human milk fortifier (BM- HMF) |
Babies will be started on bovine milk based human fortifier in ratio of 1 HMF sachet in 25 ML of milk or will be added in proportionate quantity on the basis of available quantity of milk till baby reach 1800 gram of weight. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1.Babies with birth weight 500 to ≤1500 grams
(Explanation-when baby fulfill 1st criterion then baby will receive following routine care)
Step 1- An intravenous glucose infusion/TPN/PPN 80 mL/kg/day will be started during the first hours of life.
Step 2- Progressive enteral feeding with initial volume of 30 ml/kg/day will be started in babies as per mother’s own milk availability as per unit protocol
2.Babies with milk intake of at least 100 ml/kg/day.
(Explanation: when baby reach feed volume of 100 ml/kg/day-fortification will be started)
3.Maternal intent to provide breast milk.
(Explanation: Fortification is only for the breast milk)
|
|
| ExclusionCriteria |
| Details |
1.Parents and guardians unwilling to provide consent for the study.
2.Major congenital malformation.
3.Necrotising enterocolitis.
4.Complete unavailability of mother’s own milk.
5.Mother’s milk is contraindicated.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of weight gain (g/kg/day) till 1800 grams of weight achieved. |
Daily weight will be checked till baby attain 1800 gram weight |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken to reach weight of 1800 grams (days)
2. Length gain (cm/week) till 1800 grams.
3. Head circumference gain (cm/week) till 1800 grams
4. Laboratory parameters
Laboratory Parameters:
1. Blood Urea Nitrogen – Baseline and once weekly till 1800 grams of weight achieved.
2. Total serum proteins, Serum Albumin Levels – Baseline and once weekly till 1800 grams of weight achieved.
3. Ionic Calcium, Serum Phosphorus, Serum Alkaline phosphatase -Baseline and once weekly till 1800 grams of weight achieved.
4. Serum Sodium and serum potassium- Baseline and once weekly till 1800 grams of weight achieved.
5. Vitamin d level- Baseline and at 1800 grams of weight.
|
1. Time(days taken to achieve weight of 1800 grams)
2. Weekly length measurement till 1800 gram
3. Weekly head circumference measurement.
Laboratory parameters as described
Baseline(After enrollment in trial before starting intervention), weekly and at the time of attainment of 1800 grams of weight. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 4 |
|
Date of First Enrollment (India)
|
09/11/2024 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Background- Nutritional requirements especially protein requirement in very low birth weight preterm babies is higher than their term counterparts. Human milk fortification has been done to increase the protein content of mother’s own milk and thus to enhance growth of the babies. Till now, only bovine milk based human milk fortifiers (BM-HMF) with protein content of (0.27-0.3g/ 1g sachet) were available in India, recently amino acid based human milk fortifier (AA-HMF) with higher protein content (0.35g/1g sachet) is made available. Only few studies done in India where it has shown that amino acid based fortifier is well tolerated. Extra calories and protein content in amino acid based fortifier may lead to better weight gain compare to existing practice. Current practice of adding BM-HMF has proven efficacy but issues with gastrointestinal intolerance. Fortification with AA-HMF has been demonstrated to be safe in VLBW neonates. Amino acid based human milk fortifier has shown benefits in terms of the improved weight gain, reducing overall morbidity in VLBW neonates. Our study is being planned with the aim to compare effectiveness of AA-HMF compare to existing standard practice of adding BM-HMF in human milk to increase caloric and nutritional value.
Methods: Trial will be done on very low birth weight neonates (500 to <1500grams) admitted in neonatal intensive care unit. Eligibility assessment will be done followed by stratification based on the birth weight (500g- 999grams and 1000-1499grams). These babies will be randomized to the comparator and intervention group, when they satisfy the inclusion criteria. Comparator group- Babies will receive bovine milk derived – human milk fortifier (BM-HMF) as per the current standard practice. Intervention group- Babies will receive amino acid based- human milk fortifier (AA-HMF). Babies will be monitored for weight gain, other anthropometric parameters like length and head circumference and laboratory parameters as per the existing neonatal intensive care unit protocol. |