| CTRI Number |
CTRI/2024/06/068470 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A research project looked into how feeding babies with human milk while they are in the hospital after being born prematurely affects their brain development when they are 18 to 20 months old. |
|
Scientific Title of Study
|
A STUDY ON THE ASSOCIATION OF HUMAN MILK FEEDING DURING THE
NEONATAL HOSPITALIZATION ON NEURODEVELOPMENT OF LBW BABIES OF
18 TO 20 MONTHS OF AGE A ONE YEAR COHORT STUDY |
| 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 Anusha Shridhar |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University. |
| Address |
Department Of Paediatrics, Jawaharlal Nehru Medical College,Nehru Nagar, KLE Hospital Road, Belgavi,Karnataka– 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9739311995 |
| Fax |
|
| Email |
anushashridhar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa M Bellad |
| Designation |
MD DCH professor department of paediatrics |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University. |
| Address |
Department Of Paediatrics, Jawaharlal Nehru Medical College,Nehru Nagar, KLE Hospital Road, Belgavi,Karnataka– 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448113403 |
| Fax |
|
| Email |
belladroopa5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha Shridhar |
| Designation |
Post graduate |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University. |
| Address |
Department Of Paediatrics, Jawaharlal Nehru Medical College,Nehru Nagar, KLE Hospital Road, Belgavi,Karnataka– 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9739311995 |
| Fax |
|
| Email |
anushashridhar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College,Nehru Nagar, KLE Hospital Road, Belgavi,Karnataka– 590010
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College KLE University Belgavi |
| Address |
KLE Dr Prabhakar Kore Hospital Jawaharlal Nehru Medical College KLE University Belgavi
India
PIN code- 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 Anusha Shridhar |
KLEs Dr Prabhakar Kore Hospital Belgavi |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum
KARNATAKA
Belgaum
KARNATAKA |
09739311995
anushashridhar97@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18 to 20months old babies recruited to see how breastfeeding( DHM OR/and MOTHERS OWN MILK) effects Neuro development and growth. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
20.00 Month(s) |
| Gender |
Both |
| Details |
1) Low birth weight babies (less than 2.5kg)
2) Babies who were received donor human milk for ≥ 5 days duration.
3) Parents of babies who give consent and are willing to take part in the
study.
4) Babies living within 50 KM from DR. Prabhakar Kore Hospital and Medical Research Centre , Belagavi, Karnataka. |
|
| ExclusionCriteria |
| Details |
1) Babies with congenital or chromosomal anomalies that might contribute to poor
developmental outcome.
2) Birth asphyxia .
3) Babies with blindness, hearing and speech disabilities (cranial nerve injuries)
4) Babies with history of feeding difficulties. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association of human milk feeding (mother’s own milk and or donor human milk) during the neonatal hospitalisation on the neurodevelopment of low birth weight babies of 18 to 20 months of age. |
The study will be conducted for a span of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study association of the total duration of human milk feeding (mother’s own milk and/or donor human milk) on the growth of infant at 18-20 months of age. |
The study will be conducted for a span of one year |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
14/06/2024 |
| 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="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
|
Breast milk serves as the initial nourishment in a child’s life, providing a healthy and nutritious beginning. Mother’s own milk diet in infants has substantial supporting evidence for reducing the occurrence of late onset sepsis, Bronchopulmonary dysplasia, Retinopathy of Prematurity (ROP), and Necrotizing Enterocolitis (NEC). Additionally, it enhances feeding tolerance, shortens hospital stays, and decreases medical costs. The less developed brain of preterm infants, particularly those with LBW, theoretically could benefit from feeding maternal milk since it contains critical nutrients such as long chain poly- unsaturated fatty acids (LCPUFA) and possibly other neurotrophic factors. Low-birth-weight infants, being among the most vulnerable in our society, require special attention and a heightened commitment to comprehensive care, particularly in nutritional aspects influencing neurodevelopment. Numerous studies emphasize the significance of a mother’s own milk, while only a few focus on pasteurized donor human milk. Additionally, there’s a scarcity of Indian research on the link between pasteurized donor human milk and neurodevelopment, prompting the initiation of this study. |