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CTRI Number  CTRI/2025/09/094983 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Human Milk Fortification ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Fortified Human Milk on neuromotor outcomes in preterm infants 
Scientific Title of Study   Effect of Human milk fortification on neuromotor outcomes in preterm infants: one year hospital based randomised control 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 Shreya Katariya 
Designation  Paediatric PG Resident 
Affiliation  Jawaharlal Nehru Medical College KLE University  
Address  Department of Paediatrics Ground Floor Jawaharlal Nehru Medical College KLE University Nehru Nagar, KLE Hospital Road Belgaum India

Belgaum
KARNATAKA
590010
India 
Phone  7297830071  
Fax    
Email  shreya99299@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S M Dhaded 
Designation  Professor and Head of Department of Neonatology 
Affiliation  Jawaharlal Nehru Medical College, KLE University  
Address  Department of Neonatology, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9844232586  
Fax    
Email  drdhadedsm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S M Dhaded 
Designation  Professor and Head of Department of Neonatology 
Affiliation  Jawaharlal Nehru Medical College, KLE University  
Address  Department of Neonatology, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9844232586  
Fax    
Email  drdhadedsm@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College KLE University Belagavi 
Address  Department of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum Karnataka 590010 
Type of Sponsor  Research institution and hospital 
 
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 Shreya Katariya   KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College  Department of Paediatrics Ground Floor Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum Karnataka 590010
Belgaum
KARNATAKA 		 7297830071

shreya99299@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics 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  Human Milk Fortification   Intervention group will be supplemented with Fortified Human Milk for at least 21 days and then assessed for neuromotor outcomes after 21 days of mandatory observation at more than 34 weeks of gestation using General Movement Assessment (GMA) by trained personnel. 
Comparator Agent  Unfortified Human Milk  Control group receives unfortified human milk for at least 21 days and then assessed for neuromotor outcomes after 21 days of mandatory observation at more than 34 weeks of gestation using General Movement Assessment (GMA) by trained personnel. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  2.00 Day(s)
Gender  Both 
Details  1. Very Low Birth Weight (less than or equal to 1.5kg) or very preterm (28-32 weeks) infants admitted to NICU at study facility less than 24 hours after birth for inborn infants and upto 48 hours for out-born infants.
2. Lives within catchment areas of the facility (50km).
3. Mother intends to stay in catchment area of the study facility for at least 3 months.
4. At randomisation: Infant receiving at least 60 mL per kg in per day of human milk (On Day 10 of life)
5. Willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Lives outside the defined catchment area.
2. Congenital abnormalities or acquired conditions that interfere with feeding or placement of Nasogastric/Orogastric tube [cleft lip /palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, necrotising enterocolitis]
3. Severe birth asphyxia
4. Critically ill (i.e. not on enteral feeds)
5. Unknown date of birth and unknown gestational age 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Human milk fortification on neuromotor outcomes in preterm infants using General Movement Assessment (GMA).  At the time of discharge from hospital 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of risk factors like birth weight, birth length, gestation, gender and weight gain on neuromotor function in the study subjects.  The infants will be monitored from the date of admission till the date of discharge. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   29/09/2025 
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  
In this study we will be seeing the effect of human milk fortification on neuromotor outcomes in preterm infants. Very preterm infants are at high risk for range of complications. Beyond survival, a major concern for this population is the increased risk of long-term neurodevelopment impairments, including cognitive delays, motor dysfunction, and behavioural issues.
Due to their limited physiological reserves and high nutritional demands, very preterm infants require specialised care in neonatal intensive care unit (NICU). Early interventions, including optimal nutritional strategies, are essential to support growth, organ maturation, and neurodevelopment.Thus, optimisation of the nutritional care of preterm infants has a key role in improving neurodevelopment outcomes and it is a priority. However, the nutrient composition of human milk alone is often insufficient to meet the high metabolic demands of preterm infants, necessitating human milk fortification to ensure adequate weight gain, linear growth and neurodevelopment outcomes. Early prediction of cerebral palsy and other neurodevelopmental delays in this population is essential to enable timely intervention, optimize outcomes, and support families.
General Movement Assessment (GMA) serves as a critical tool for evaluating early neuromotor function in preterm infants. Compared to other tools like Bayley scales or HINE, GMA offers the distinct advantage of being a non-invasive, cost-effective, highly predictive method that can be used as early as neonatal period. Studies have shown that the absence or abnormality of these moments can predict cerebral palsy with over 90% accuracy- well before traditional assessments like Bayley and HINE. 
The infants enrolled into this study will be assessed for neuromotor outcomes at the time of discharge using General Movement Assessment (GMA) by trained personnel. This will be done either by direct observation or by video recording for the purpose. Movements will be assessed, and scores will be given as normal and abnormal (poor-repertoire, cramped-synchronised, chaotic movements).
 
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