| CTRI Number |
CTRI/2024/06/068977 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [human milk fortifier] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on different strategies of fortification of breast milk in very low birth weight infants to improve growth |
|
Scientific Title of Study
|
Comparison of short term weight gain in very low birth weight (VLBW) neonates receiving expressed breast milk (EBM) fortified with amino acid based powder formula vs conventional human milk fortifier: A randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suvarna Sindhu Kodumuru |
| Designation |
DrNB Neonatology Resident |
| Affiliation |
Fernandez Hospital |
| Address |
Fernandez Hospital,No.8-2-698, Rd number 12 , Bhola Nagar, Banjara Hills, Hyderabad , Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
7981957634 |
| Fax |
|
| Email |
suvarna.sindhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejo Pratap Oleti |
| Designation |
HOD, Neonatology |
| Affiliation |
Fernandez Hospital |
| Address |
Fernandez Hospital,No.8-2-698, Rd number 12 , Bhola Nagar, Banjara Hills, Hyderabad , Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9989372490 |
| Fax |
|
| Email |
tejopratap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejo Pratap Oleti |
| Designation |
HOD, Neonatology |
| Affiliation |
Fernandez Hospital |
| Address |
Fernandez Hospital,No.8-2-698, Rd number 12 , Bhola Nagar, Banjara Hills, Hyderabad , Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9989372490 |
| Fax |
|
| Email |
tejopratap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fernandez hospital, 8-2-698, Rd Number 12, Bhola nagar, Banjara Hills, Hyderabad, Telangana- 500034 |
|
|
Primary Sponsor
|
| Name |
Fernandez Hospital |
| Address |
fernandez hospital, No.8-2-698, Rd number12,Bhola Nagar,Banjara Hills,Hyderabad, Telangana - 500034 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Suvarna Sindhu |
Fernandez Hospital |
Neonatal Intensive Care Unit, Department of Neonatology, Room no 301, 3rd Floor, Fernandez Hospital, H.NO: 8-2-698, Rd number 12, Bhola Nagar , Banjara Hills , Hyderabad, telangana
Hyderabad
TELANGANA |
7981957634
suvarna.sindhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
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 |
Amino acid based formula powder (Neocate LCP) as fortifier |
1gm in 25 ml of expressed breast milk. |
| Comparator Agent |
Conventional Human Milk Fortifier (Lactodex HMF) |
1gm in 25 ml of expressed breast milk |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
Neonates who are born before 32weeks of gestational age and are having the following characteristics :
a.Birth weight of less 1000gm
b.Birth weight between 1000 to 1250gm and are
having abnormal doppler studies antenatally or
postnatally. |
|
| ExclusionCriteria |
| Details |
Neonates with the following conditions will be excluded:
a. Major congenital malformation
b. Hydrops
c. Any gastrointestinal surgery prior to
intervention. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the weight gain in gm/kg/day between the neonates receiving expressed breast milk fortified with amino acid based powder formula vs conventional human milk fortifier. |
Everyday from the start of fortification (neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gain in length ( cm/week) between both the groups . |
From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital |
| Gain in head circumference(cm/week) between both the groups. |
From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital |
| Incidence of neonatal morbidities such as feed intolerance, necrotising enterocolitis , metabolic bone disease etc between both the groups. |
From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/06/2024 |
| 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="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
|
Human milk (HM) is considered as the gold standard for nutrition in preterm neonates.To meet the increased nutritional demands in preterm neonates, AAP recommends fortification of HM as the standard of care in preterm infants, less than 1500 g at birth.Several studies have shown that the in-hospital growth rates of preterm neonates who received fortified human breast milk with either human milk fortifiers or infant formula powder were better compared to the preterms who are fed with non-fortified breast milk.
In India, EBM in commonly fortified by using bovine based powdered HMF ( Lactodex HMF ). However, there are few concerns regarding the association of bovine based multicomponent fortifier with development of feed intolerance and NEC especially in very low birth weight neonates who are at a higher risk.
Currently, we are using Amino acid based powder formula as fortifier in VLBW infants with feed intolerance as it is non bovine based and better tolerated. Also, using Amino acid based formula powder as fortifier will be a more economical option.Hence we want to consider amino acid based formula powder as a primary fortifier and compare the growth patterns in VLBW infants receiving EBM fortified with amino acid based formula powder vs the conventional human milk fortifier and also assess the incidence of neonatal complications between both the groups. |