| CTRI Number |
CTRI/2025/02/079878 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2026 |
| 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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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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], |
|
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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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
19/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/01/2026 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sent for publication in Indian Journal of Pediatrics. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study was done to analyse effect of early (80 mL/kg/day) versus late fortification (150
mL/kg/day) in preterm neonates on anthropometry at discharge, anthropometry and
neurodevelopment at 6 months’ corrected age.Sixty-six preterm neonates (gestational
age-26-24 weeks and birth weight 600-1800 grams) were randomized. Primary
outcome was rate of weight gain (g/kg/day) after regaining birth weight during
NICU stay; which was analysed by three different methods as secondary outcome.
Various morbidities, side effects of fortification, anthropometry, neurodevelopment
by Trivandrum Development Screening Chart (TDSC) at 1, 3, and 6 months’
corrected age were also studied. In results, baseline neonatal and maternal characteristics were comparable. Median
birth weight [1430 g (IQR:1192–1675) vs 1436 g
(IQR:1242–1622); p=0.980] and gestational
age [31 weeks (IQR:30–33) vs 32 weeks (IQR:30–33); p=0.571]
were similar. Early fortification showed higher median weight gain velocity
(18.3 vs 14 g/kg/day; p=0.062) though not statistically significant. Subgroup
analysis and analysis of rate of weight gain by three different methods showed
uniform trend favouring early fortification. Linear and head growth were
similar. Rates of necrotising enterocolitis, feed intolerance, extra-uterine
growth restriction, mortality, post-discharge growth and neurodevelopment were
also similar. It was concluded that early fortification of feeds at around 80
mL/kg/day appears feasible and safe in preterm neonates, with consistent trends
toward improved growth velocity but post-discharge growth and short-term
neurodevelopmental outcomes are similar.
|