FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095165 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 21/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Hydrolyzed Protein Powder]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of protein enriched milk feeding in preterm infants 
Scientific Title of Study   Evaluation of Safety and Efficacy of Routine Addition of Hydrolyzed Protein Powder to Human Milk Fortifier Enriched Human Milk for Enteral Nutrition Compared to Conventional Human Milk Fortification in Preterm Infants: A 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  Ompriya T P 
Designation  Postgraduate 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE ,KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH ,BELAGAVI ,KARNATAKA 
Address  PG Resident of Paeditrics ,Jawaharlal Nehru Medical College ,KLE Academy of Higher Education and Research ,Belagavi ,Karnataka -590010

Belgaum
KARNATAKA
590010
India 
Phone  8971240074  
Fax    
Email  priya20harshitha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramachandra Bhat 
Designation  Associate Professor ,Department Of Neonatology 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE ,KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH ,BELAGAVI ,KARNATAKA 
Address  Department of Neonatology,Jawaharlal Nehru Medical College ,KLE Academy of Higher Education and Research ,Belagavi ,Karnataka -590010

Belgaum
KARNATAKA
590010
India 
Phone  6361968926  
Fax    
Email  rambhat79@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ompriya T P 
Designation  Postgraduate 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE ,KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH ,BELAGAVI ,KARNATAKA 
Address  PG Resident of Paeditrics ,Jawaharlal Nehru Medical College ,KLE Academy of Higher Education and Research ,Belagavi ,Karnataka -590010

Belgaum
KARNATAKA
590010
India 
Phone  8971240074  
Fax    
Email  priya20harshitha@gmail.com  
 
Source of Monetary or Material Support  
Jawharlal Nehru Medical College ,KLE Dr Prabhakar Kore Charitable hospital ,belagavi ,Karnataka,590010 
 
Primary Sponsor  
Name  Ompriya T P 
Address  PG Resident of Paeditrics ,Jawaharlal Nehru Medical College ,KLE Academy of Higher Education and Research ,Belagavi ,Karnataka -590010  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ompriya T P  Dr KLEs Prabhakar kore hospital  Department Of Paeditrics,NICU,Jawaharlal Nehru Medical College ,KLE Academy of Higher Education and Research ,Belagavi ,Karnataka -590010
Belgaum
KARNATAKA 
8971240074
590010
priya20harshitha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Ethical Institutional Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Extensively Hydrolyzed Powdered Protein Fortification on top of standard fortification  Already fortified human milk-based enteral diet using standard fortification (0.81 kcal/1 ml or 4g/100ml or 1g sachet per 25ml; multi-component) will be routinely supplemented with additional AA-based powdered protein fortifier (mono-component). Initially, 0.5g/day of powdered protein fortifier (one sachet of 0.5g) will be added to the fortified human milk, the dose will be divided into four equal doses per day. The dose will be escalated to a maximum of 1g per day in four divided doses based on the tolerance. Duration of protein fortification: until hospital discharge or 36 weeks; whichever is earlier 
Comparator Agent  Standard, multi-nutrient fortification without protein enrichment Non-Fortified Protein Group  total fluid volume, volume of advancement of enteral feeds, and the duration of multi-nutrient fortification are at the discretion of the treating physician 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  2.00 Day(s)
Gender  Both 
Details  Inclusion Criteria All criteria must be met
Preterm infants born less than 32 weeks of gestation OR birth weight less than 1500 g
At least two weeks of hospital stay is expected
Receiving a minimum of 100 ml kg of enteral feeds with human milk based diet either DBM or maternal breast milk fortified with multi nutrient HMF to a standard fortification 0.81 kcal 1 ml or 4 g 100 ml or 1 g sachet per 25 ml
Consent obtained for parents
Chronological or postnatal age greater than 7 days
 
 
ExclusionCriteria 
Details  Neonates with
Major Congenital anomalies(known or diagnosed)
Chromosomal abnormalities/Identifiable genetic syndrome
GI surgical procedure/short bowel syndrome/ostomies
NPO status: NEC/feeding intolerance/inotrope-dependent shock
Potential non-viabiity and clinical instability as determined by the treating physician
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety endpoint is rate of feeding intolerance defined as gastric residual volume greater than 50 percent of the last feed or abdominal distension or emesis requiring withholding of feeds or interruption of feeding for more than 24 hours. Primary efficacy endpoint is rate of postnatal growth failure defined as weight for age z score decline more than 0.8 or weight gain velocity less than 75 percent of expected for postconceptional age assessed at discharge or 34 weeks PMA whichever is later  At Baseline and weekly interval at discharge or 34 weeks PMA  
 
Secondary Outcome  
Outcome  TimePoints 
.Secondary outcomes (Safety)
1. Necrotizing Enterocolitis
2.Late Onset Sepsis
3.Recurrent feeding intolerance
4.BUN/Serum Creatinine
5.Time to achieve full enteral feeds
6.Time to achieve full oral feeds.
Secondary outcomes (efficacy)
1. Weight gain velocity
2. Linear growth velocity
3. Head growth velocity
4. Body composition surrogates (BMI z scores, mid-arm Circumference, mid-thigh circumference)
5. Length of hospital stay
 
At Baseline & weekly interval at discharge or 34 weeks PMA  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/10/2025 
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 Yet Recruiting 
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  
Human breast milk especially maternal breast milk is the preferred choice for enteral nutritional support in preterm infants. Human milk based diet compared to formula feeding reduces the risk of mortality necrotizing enterocolitis NEC late onset sepsis retinopathy of prematurity bronchopulmonary dysplasia and duration of hospital stay in preterm infants. Maternal breast milk is superior to donor breast milk feeding in improving long term neurodevelopmental outcomes in preterm neonates. However there is insufficient calories major macronutrients electrolytes minerals and micronutrients in human breast milk maternal or donor to provide adequate nutritional support and to achieve optimal postnatal growth and proportionate growth in well alignment with intra uterine growth in preterm infants. Accordingly the addition of commercially available standard human milk to human breast milk is routinely being used to mitigate the risks of nutritional insufficiency and suboptimal growth in preterm neonates particularly those with very low birth weight and intra uterine growth restricted neonates as they require enhanced nutritional support to promote physical growth and neurodevelopment. Despite standardized fortification the required daily protein intake may not be met due to restrictive fluid regimen insufficient absorption and poor assimilation in preterm infants. Hydrolyzed protein powder which consists of amino acids is hypothesized to enhance protein absorption and reduce the risk of protein deficiency and promote linear growth head growth and proportionate growth without offsetting the feeding tolerance

This study focuses on preterm neonates who are often deprived of adequate protein supplementation as limited research has been conducted in India on optimized protein supplementation strategies. Based on the biological plausibility we speculate that the addition of extensively hydrolyzed protein powder to already fortified human milk with standard HMF fortification will promote short term physical growth parameters without increasing feeding intolerance in preterm infants. Furthermore this approach may support improved long term neurodevelopmental outcomes. The study aims to evaluate the short term efficacy safety and feasibility of this nutritional strategy using protein fortified powders currently available in India.
 
Close