CTRI

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CTRI Number

CTRI/2024/04/065657 [Registered on: 15/04/2024] Trial Registered Prospectively

Last Modified On:

05/03/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Screening

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Effect of donar human milk on the weight of less days born babies

Scientific Title of Study

Study of Pateurized donor human milk on the growth of Preterm neonates:Randomized Control 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	AKANSHA SISODIA
Designation	DM RESIDENT
Affiliation	DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESERACH,SAWANGI(M)
Address	Department of Neonatology, NICU 2nd floor AVBRH building,Sawangi(Meghe),Wardha Wardha MAHARASHTRA 442107 India
Phone	7030630366
Fax
Email	akanshasisodia12@gmail.com

Details of Contact Person
Scientific Query

Name	Dr.Pramod Sangvi
Designation	Professor (Department of Neonatology)
Affiliation	DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESERACH,SAWANGI(M)
Address	Department of Neonatology, NICU 2nd floor AVBRH building,Sawangi(Meghe),Wardha Wardha MAHARASHTRA 442107 India
Phone	9422144251
Fax
Email	pmdsanghvi@gmail.com

Details of Contact Person
Public Query

Name	AKANSHA SISODIA
Designation	DM NEONATOLOGY RESIDENT(SR)
Affiliation	DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESERACH,SAWANGI(M)
Address	Department of Neonatology, 2nd floor,AVBRH building,Sawangi(Meghe),Wardha Wardha MAHARASHTRA 442107 India
Phone	7030630366
Fax
Email	akanshasisodia12@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Akansha Sisodia
Address	Datta Meghe Institute of Higher Education and Research,Sawangi(Meghe),Wardha
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Akansha sisodia	Datta Meghe Institute of Higher Education and Research,Sawangi(Meghe),Wardha	Department of Neonatology, NICU 2nd floor,AVBRH building,Sawangi(Meghe),Wardha Wardha MAHARASHTRA	7030630366 akanshasisodia12@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICICS COMMITTEE,DMIHER(DU)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	preterm neonate less than 37 th week

Intervention / Comparator Agent

Type	Name	Details
Intervention	Human donor milk	Weight,Height and Head circumference in three groups.Group A on Mothers milk,Group B on Human donor milk and Group C who are fed on both and formula. Duration of study to be done over the period of 2 years
Comparator Agent	Weight / Lenght/Head circumference	Comparing Weight ,Head circumference and length of preterms in three groups naming Group A-exclusively on mother own milk Group B- Human donar milk Group C- who are fed on both Mother own milk and Human Donor milk

Inclusion Criteria

Age From	1.00 Day(s)
Age To	28.00 Day(s)
Gender	Both
Details	Preterm less than 37 th weeks on enteral feeding till the discharge

ExclusionCriteria

Details

any major congenital anomalies,Nil orally for one week or more,severe metabolic disorders where milk feeds are contraindicated

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
compare anthropometric indices of all three groups naming Group A-Babies on Mother own milk Group B-Babies on Human Donor milk Group C-Babies who are fed on all type of milk like mother own milk,Human donor milk,Formula feeding	weight daily ,Head circumference weekly , length weekly

Secondary Outcome

Outcome	TimePoints
morbidity & mortality(if any) in any group naming Group A-Babies on mother own milk Group B-Babies on Human donar milk Group c-Babies on all type of milk-Mother own milk,Human donar milk,Formula feeding	whenever it happens in during the course of stay from the day of admission till the discharge from NICU

Target Sample Size

Total Sample Size="75"
Sample Size from India="75"
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 3/ Phase 4

Date of First Enrollment (India)

01/05/2024

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="2"
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

every infant deserves the best possible start in their life in terms of nutrition by breast feeding or receiving donated milk.human milk is the heathiest form of nutrition by breast feeding or receving donated human milk..The WHO recommends that for donated milk is the next preferred form of milk for infants who cannot be breast fed.in donar micrnutrients and antiinfective factors are lost during pasteurization and decomposition over time.hence human donar milk is not exactly equal to fresh mother milk.After obtaining informed consent from parents neonates will be included in the study.this single center computer generated randomized control trial compare data from preterm infants supplemented with predominently mothers own milk to those infants who fed only pasteurized donar milk or who fed with both types of milk.