| CTRI Number |
CTRI/2024/06/069546 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Preterm Formula Powder (LACTODEX LBW Formula) and Human Milk Fortifier(LACTODEX HMF)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of fortification of Human Breast Milk via Preterm Formula Powder or Human Milk Fortifier in Preterm Very Low Birth Weight Neonates. |
|
Scientific Title of Study
|
Fortification of Breast Milk With Preterm Formula Powder vs Human Milk Fortifier in Preterm VLBW Neonates :A Randomized clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geeta Gathwala |
| Designation |
Senior Professor and HOD |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences(PGIMS) Rohtak HARYANA |
| Address |
Ward 14
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences(PGIMS) Rohtak HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9896489650 |
| Fax |
|
| Email |
geetagathwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Gathwala |
| Designation |
Senior Professor and HOD |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences(PGIMS) Rohtak HARYANA |
| Address |
Ward 14
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences(PGIMS) Rohtak HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9896489650 |
| Fax |
|
| Email |
geetagathwala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Yadav |
| Designation |
Junior Resident |
| Affiliation |
Pt .BD Sharma Post Graduate Institute of Medical Sciences |
| Address |
Ward 14 Department of Pediatrics Pt.BD.Sharma Poast Graduate Institue of Medical Sciences Pin-124001 Haryana India Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9050071593 |
| Fax |
|
| Email |
shikhayadav00564@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.B.D.Sharma Post Graduate Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Geeta Gathwala |
| Address |
Ward 14 Department of Pediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences(PGIMS) Rohtak HARYANA-124001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shikha Yadav |
Pt. B.D.Sharma Post Graduate Institute of Medical Sciences |
Pediatrics Department
First Division Room Nicu 14
Rohtak Haryana
124001
Rohtak
HARYANA |
9050071593
shikhayadav00564@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt.B.D.Sharma PGIMS Rohtak |
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 |
Fortification of Expressed Breast Milk with LACTODEX Low Birth Weight FORMULA |
25ml of Expressed Breast Milk will be fortified with 1gram of Lactodex Low Birth Weight
formula this intervention will be done till discharge everytime the child will breastfeed |
| Comparator Agent |
LACTODEX Human Milk Fortifier |
25ml of Expressed Breast Milk fortified with 1 sachet of lactodex Human Milk Fortifier till discharge everytime the child will breastfeed |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Month(s) |
| Gender |
Both |
| Details |
1.Preterm neonates born at ≤32 weeks of gestation and appropriate for gestational age (AGA).
2. Birth weight less than 1500 g
3. Accepting oral feeds of at least 100ml/kg/day
4. Consuming 75% of milk or more as EBM at enrolment.
|
|
| ExclusionCriteria |
| Details |
1.Neonates with major congenital anomalies
2.Neonates with severe birth asphyxia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Rate of in hospital weight gain in g/kg/d from the day of randomisation to the day of discharge. |
Initially at the time of admission and then daily till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Weekly length gain & weekly head circumference gain
2. Feed intolerance
3.Neonatal NEC stage 2 or more
4.All cause of mortality
|
Initially at the time of admission , length gain & head circumference will be measured weekly till discharge
Whereas Necrotising enterocolitis along with feed intolerance & causes of mortality will be assessed daily till discharge |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/07/2024 |
| 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 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
|
Human milk though an established feeding option is not sufficient to achieve the intrauterine growth rates in preterm neonates. Studies have shown fortification of breast milk with HMF results in net nutrient retention comparable to expected intrauterine rate of accretion in preterms .In this study we planned to compare effficacy of fortification of breast milk with LACTODEX LBW formula and LACTODEX HMF in terms of weight gain in preterm VLBW neonates. Neonates less than or equal to 32 weeks of gestation and appropriate for gestational age with birth weight less than 1500 grams were included and randomised . Expressed breast milk was fortified with LACTODEX LBW formula and LACTODEX HMF. Enrolled neonates will be followed up with weekly anthropometric audits (weight ,length, head circumference). in case of lack of adequate weight gain i.e less than less than 15g/kg/d during the weekly audit , neonates will be assessed for systemic causes , if no systemic were identified feed will be increased to 200mg/kg/d.
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