| 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
|
|
|
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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Ethical Institutional Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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
|
|
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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 |
|
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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. |