| CTRI Number |
CTRI/2025/04/086024 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Early Fortification on Growth Parameters in Neonates less than 32weeks of Gestation : A Randomized Trial. |
|
Scientific Title of Study
|
NEOFORT Effect of Early Fortification on Growth Parameters at Discharge in Neonates less than 32weeks of Gestation A Randomized Controlled Trial. |
| Trial Acronym |
Effect of Early Fortification on Growth Parameters at Discharge in Neonates less than 32weeks of Gestation A Randomized Controlled Trial. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mounica |
| Designation |
Senior Resident, DM Neonatology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Neonatology, 3rd floor, Division - SCOPE ,room no - c3 ,Udayar block, Sri Ramachandra medical Centre and Sri Ramachandra Hospital,
Porur, Chennai- 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
8500541035 |
| Fax |
|
| Email |
mounica.bharat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umamaheswari |
| Designation |
Head of the Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Neonatology, 3rd floor, Division - SCOPE ,room no - c3 ,Udayar block, Sri Ramachandra medical Centre and Sri Ramachandra Hospital,
Porur, Chennai- 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9941853855 |
| Fax |
|
| Email |
drumarajakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajarajan Paulpandian |
| Designation |
Assistant Professor |
| Affiliation |
Department of Neonatology, Sri Ramachandra medical Centre and Sri Ramachandra Hospital, Porur, Chennai- 600116 |
| Address |
Department of Neonatology, 3rd floor, Division - SCOPE ,room no - c3 ,Udayar block, Sri Ramachandra medical Centre and Sri Ramachandra Hospital,
Porur, Chennai- 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9677899801 |
| Fax |
|
| Email |
msd.raja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai, 600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandre Institute of Higher Education and Research |
| Address |
Department of Neonatology,
Porur, Chennai-600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mounica |
Sri Ramachandra medical Centre and Sri Ramachandra Hospital. |
Neonatal Intensive Care Unit,
Sri Ramachandra medical Centre and Sri Ramachandra Hospital.
Chennai
TAMIL NADU |
8500541035
mounica.bharat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Early fortification (Intervention Group)
• Initiation of enteral feedings, enteral volume advancement, and weaning off parental nutrition will follow the standardized our NICU feeding protocol.
• To start fortification of human milk once neonate reaches 40 mL/kg/d enteral feed volume using a commercial human milk fortifier till discharge.
• In case of inadequate maternal milk volume to meet daily needs, donor milk(PDHM)will be used per standard NICU feeding protocol after obtaining consent.
• Proportion will be one-gram sachet of HMF was mixed with 25 mL of human milk or according to manufacture’s instructions.
-Fortification will be continued till 40 weeks PMA of till neonate attains full breast feeding whichever is earlier. |
| Comparator Agent |
Standard fortification |
B : Standard care (Control Group)
• Initiation of enteral feedings, enteral volume advancement, and weaning off parental nutrition will follow the standardized our NICU feeding protocol.
• Human milk fortification will commence once neonates reaches 100ml/kg/day of enteral feeds using a commercial human milk fortifier till discharge.
• In case of inadequate maternal milk volume to meet daily needs, donor milk(PDHM)will be used per standard NICU feeding protocol.
• Proportion will be one-gram sachet of HMF was mixed with 25 mL of human milk or according to manufacture’s instructions.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All intramural, and extramural neonates retrieved within 12 hours of life, with gestational age at birth less than 32 weeks and or birth weight less than 1500 grams on mothers own milk or PDHM. |
|
| ExclusionCriteria |
| Details |
Neonates with major congenital malformations or surgical problems or on formula feeds.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate weight gain velocity in VLBW who receive early HM fortification compared to standard care protocols |
at the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate mean duration to regain birthweight.
2. Other growth parameters (head circumference and linear growth velocity)
3. Incidence of feed intolerance.
4. Incidence of Necrotizing Enterocolitis (NEC) stage 2,3.
5. Time to reach full feeds 150ml/kg/day.
6. Incidence of EUGR.
|
at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
14/05/2025 |
| 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 Applicable |
| 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
|
This randomized controlled trial will evaluate the effect of early versus standard fortification on growth parameters in neonates <32 weeks gestation or <1500g birth weight. Conducted at Sri Ramachandra Medical College over two years, it will include preterm neonates receiving mother’s or donor human milk, excluding those with major congenital anomalies or surgical conditions. Group A will receive early fortification at 40 mL/kg/day, while Group B will receive standard fortification at 100 mL/kg/day. The primary outcome will be weight gain velocity at discharge, with secondary outcomes including time to regain birth weight, head circumference, linear growth velocity, feeding tolerance, NEC incidence, and time to full feeds. Using block randomization stratified by gestational age, 54 neonates per group will be required (power 80%, alpha 5%). Data will be analyzed using SPSS v26, employing descriptive statistics, Chi-square, and t-tests/Mann-Whitney tests, following an intention-to-treat approach. Ethical approval will be obtained, and parental consent will ensure confidentiality. |