| CTRI Number |
CTRI/2024/08/072630 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
fortification of mother breast milk to prevent after birth growth failure in preterm infants |
|
Scientific Title of Study
|
Targeted fortification of maternal breast milk to prevent postnatal growth failure in preterm infants : A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shireesha reddy vasantha |
| Designation |
Junior resident , paediatrics |
| Affiliation |
Jawaharlal Nehru Medical College,KLE University |
| Address |
Department of paediatrics ,Jawaharlal nehru medical college , KLE hospital road, belgaum , karnataka ,590010,india
Belgaum
KARNATAKA
590010
India |
| Phone |
7330906213 |
| Fax |
|
| Email |
sireeshareddyvasantha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramachandra bhat |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Nehru Medical College,KLE University |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
KARNATAKA
590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
6361968926 |
| Fax |
|
| Email |
rambhat79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramachandra bhat |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Nehru Medical College,KLE University |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
KARNATAKA
590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
6361968926 |
| Fax |
|
| Email |
rambhat79@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belagavi |
|
|
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 |
Private medical college |
|
|
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 Shireesha reddy |
KLEs Dr Prabhakar Kore hospital, Belagavi |
Department of Paediatrics, Jawaharlal Nehru Medical College, nehrunagar belagavi
KARNATAKA,590010
Belgaum
KARNATAKA |
7330906213
sireeshareddyvasantha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P051||Newborn small for gestational age, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
20cc of Milk for every feed will be give and analysis followed by targeted fortification with 1 hmf ( Human Milk fortifier sachet as per standard norms) in each feed. |
Fortification with HMF sachet will be done for atleast seven days or as long the neonate stays in the hospital which ever is longer. |
| Comparator Agent |
Neonates will be recieving only breast milk with or without standard fortification based on the consultant |
Standard fortification may or mat not be done |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants less 32 6/7 weeks of gestation or less than 1250 grams |
|
| ExclusionCriteria |
| Details |
a. Congenital anomalies
b. Chromosomal abnormalities
c. GI surgical procedure/short bowel syndrome/ostomies
d. NPO status: NEC/feeding intolerance/inotrope dependent shock |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect of targeted fortification of maternal breast milk in preventing post natal growth failure |
To see the effect of targeted fortification of maternal breast milk in preventing post natal growth failure at the time of discharge and at 40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate effects of targeted fortification on in hospital survival & anthropometric measures |
Baby is assessed at the time of discharge & at 40 week post menstrual 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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
31/08/2024 |
| 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 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
|
Human breast milk is considered an ideal type of enteral nutrition among preterm neonates as the available evidence indicates both short-term and long-term benefits. However, for preterm infants, the amount of calories, macronutrients, electrolytes, minerals, and micronutrients provided by human breast milk (either maternal or donor breast milk) is insufficient to support and ensure appropriate postnatal growth that is on par with intra-uterine growth. Consequently, fortification of human breast milk with commercially available standard human milk fortifier is being undertaken to meet the deficit nutritional needs. Nevertheless, a significant proportion of preterm infants still do not achieve recommended postnatal growth velocity due to macronutrients and calorie insufficiency because of varied breast milk composition across the maternal population. Targeted fortification of maternal breast milk facilitates the optimization of of enteral nutritional intake through the measurement of the macronutrient and calorie content of native breast milk, adding standard human milk fortifier, and individually adjusting calorie, protein, and fat content with protein and fat human milk additives to reach ESPGHAN recommended daily requirements. Thus, the process may improve the postnatal growth velocity, facilitate proportionate growth, and minimize postnatal growth failure among preterm infants. |