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CTRI Number  CTRI/2025/02/079878 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Time of starting fortification of feeds in preterm neonates admitted to neonatal intensive care unit. 
Scientific Title of Study   Early versus late fortification of feeds in preterm neonates admitted to neonatal intensive care unit-A randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saikat Patra 
Designation  Associate Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology HIMS SRHU

Dehradun
UTTARANCHAL
248140
India 
Phone  9780317739  
Fax    
Email  dr.saikatpatra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravleen Kaur 
Designation  Senior Resident Neonatology 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology Himalayan Institute of Medical Sciences SRHU, Jolly Grant, Swami Ram Nagar

Dehradun
UTTARANCHAL
248016
India 
Phone  9646753450  
Fax    
Email  ravleen135@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saikat Patra 
Designation  Associate Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology HIMS SRHU

Dehradun
UTTARANCHAL
248140
India 
Phone  9780317739  
Fax    
Email  dr.saikatpatra@gmail.com  
 
Source of Monetary or Material Support  
Himalayan Institute of Medical Sciences, SRHU, Jolly Grant, Swami Ram Nagar, Beside Jolly Grant Airport, Dehradun, Uttarakhand 248016, India 
 
Primary Sponsor  
Name  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology Himalayan Institute of Medical Sciences, SRHU, Jolly Grant, Swami Ram Nagar, Beside Jolly Grant Airport, Dehradun, Uttarakhand 248016, India 
Type of Sponsor  Private medical college 
 
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 Saikat Patra  Himalayan Institute of Medical Sciences  NICU-Ward No. 110,First Floor Hospital building;Neurodevelopmental OPD-Room No.14, Ground Floor, Hospital building, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Swami Ram Nagar, 248016
Dehradun
UTTARANCHAL 		 9780317739

dr.saikatpatra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee,Swami Rama Himalayan University.  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  Early Fortification with Human Milk Fortifier (HMF)  Done at feed volume of 80 mL/kg/day.1 HMF sachet will be added in 25 mL breast milk and required volume will be given every 2 hourly. Number of HMF sachets received by the patient will be calculated daily. 
Comparator Agent  Late Fortification with Human Milk Fortifier(HMF)  Done at feed volume of 150 mL/kg/day.1 HMF sachet will be added in 25 mL breast milk and required volume will be given every 2 hourly. Number of HMF sachets received by the patient will be calculated daily. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Preterm neonates born at gestational age 26-34 weeks and birth weight 600 g-1800 g on enteral feeds of 80mL /kg/day.
 
 
ExclusionCriteria 
Details  1. Neonates with gross congenital anomalies.
2. Those with NEC stage 2 or worse (Modified Bell’s staging) prior to enrollment.
3. Those with genetic or metabolic syndromes.
4. Those with surgical gastro-intestinal condition.
5. Those on formula feed.
6. Outborn neonates already on feed more than 80mL/kg/day.
7. More than two episodes of feed intolerance prior to enrollment.
8. Parents who don’t give written informed consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of weight gain after regaining birth weight (g/kg/day) during NICU stay.  At discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Linear growth (cm/week) and increase in head circumference (cm/week) during NICU stay.  At discharge 
Day of regaining birth weight.  During NICU stay 
Gross weight gain after regaining birth weight.  At discharge 
Rate of weight gain since addition of HMF.  At discharge 
Rate of weight gain from birth weight.  At discharge 
Rate of weight gain from nadir weight.  At discharge 
Total number of HMF days.  At discharge 
Incidence of extra-uterine growth restriction.  At discharge 
Incidence of necrotising enterocolitis (NEC) stage 2 or worse (Modified Bell’s staging)  At discharge 
Incidence of invasive infection as determined as confirmed by positive culture of bacteria or fungus from blood, cerebrospinal fluid, urine or a normally sterile body space.  At discharge 
Duration of parenteral nutrition (PN) (days).  At discharge 
Duration of central venous line (CVL) usage (days).  At discharge 
Number of infants with retinopathy of prematurity requiring treatment, intraventricular hemorrhage, bronchopulmonary dysplasia, metabolic bone disease, anemia  At discharge 
Duration of hospital stay (days).  At discharge 
All-cause mortality   At discharge 
Rate of weight gain after regaining birth weight (g/kg/day), linear growth (cm/week), and increase in head circumference (cm/week)   At 1, 3 and 6 months’ corrected age and at latest follow-up. 
Hearing evaluation by BERA.  Before 3 months age 
Visual assessment
 		 At 6 months corrected age 
Neurodevelopmental assessment  At 6 months corrected age 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   10/02/2025 
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="6"
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   Inborn and outborn neonates fulfilling inclusion and without the exclusion criteria will be randomized when feeds reach 80 mL/kg/day by computer generated stratified randomization (variable-sized blocks of 2-6 study subjects). Stratification will be done into two groups according to gestational age at birth (Group A= 26-30 week and Group B= 31-34 week) in a ratio of 1:2 respectively. So a minimum of 22 and 44 subjects will be enrolled from group A and B respectively. Fortification of the early group will be started when feed volume reaches 80 ml/kg/day and late group will be started when the volume of breastmilk feeding reaches 150 mL/kg/day. One sachet of HMF will be added to 25 mL of human milk and then, required volume will be given to neonate at 2 hour intervals. Fortification will be stopped when infant reaches weight of 2.5 kg or comes on complete breastfeeding, whichever is earlier. Number of sachets will be counted daily to ensure the actual delivery of the intended intervention. Fortification will be done by Lactodex-Human Milk Fortifier (HMF). The infant’s weight will be measured daily and weight gain monitoring will be done daily. Length and head circumference will be measured weekly. Weight, length and head circumference will be plotted on gender appropriate International Postnatal Growth Standards for Preterm Infants (Intergrowth 21st growth charts) weekly, at discharge and latest follow-up till 6 months of corrected age. Feed intolerance will be considered if feed is stopped for more than or equal to 12 hours. Feed will be restarted once there is systemic improvement with no OG aspirates and abdomen is clinically better. Feeds will be restarted at a volume based on clinician’s discretion. HMF interruptions will be based on clinician assessment suggesting HMF attributing to feed intolerance. HMF will be restarted at least after 24 hours as per clinician decision. Baby will no longer be part of the study if more than 2 episodes of feed intolerance or more than 2 deliberate interruptions in HMF administration due to clinician discretion occur. The baby will no longer be considered for per protocol analysis and will be managed as per clinician discretion. Baby will be discharged when weight is more than or equal to 1500 g,weight gain for 3 consecutive days, hemodynamically stable, adequate maintenance of normal body temperature fully clothed in an open bed with normal ambient temperature, on paladai or  breast feeds, completed immunisation, metabolic screening, hematologic status ,fundoscopic and hearing evaluation, completed assessment of neurodevelopment and neurobehavioural status and mother is confident in feeding and giving medications to the baby. Patients will be followed-up at 1, 3 and 6 months’ corrected age for anthropometry and neurodevelopmental assessment. Parents will be allowed to withdraw from the trial with any financial and treatment consequences. 
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