| CTRI Number |
CTRI/2025/08/093864 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Do lab tests and hospital records show the same protein levels in preterm babies’ milk? |
|
Scientific Title of Study
|
Comparison of protein intake in preterm infants: milk analysis versus nutrition audit – A prospective observational 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 Merin Mathew |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research(JIPMER) |
| Address |
Department of Paediatrics, 2nd floor, Women and Child block,
JIPMER, Dhanavantari Nagar
Puducherry
Dhanavantari Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9544419421 |
| Fax |
|
| Email |
merinmathew553@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Devi R |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research(JIPMER) |
| Address |
Department of Neonatology,
2nd floor, Women and child block, JIPMER, Dhanavantari Nagar, Puducherry
Dhanavantari Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9962653294 |
| Fax |
|
| Email |
drushaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Devi R |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research(JIPMER) |
| Address |
Department of Neonatology,
2nd floor, Women and child block, JIPMER, Dhanavantari Nagar, Puducherry
Dhanavantari Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9962653294 |
| Fax |
|
| Email |
drushaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund, JIPMER, second floor, WCH block, Dhanvanthri nagar, Pondicherry- 605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Post Graduate Medical Education and Research(JIPMER) |
| Address |
Dhanavantari Nagar
Puducherry-605006 India |
| Type of Sponsor |
Government 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 Usha Devi |
JIPMER |
Department of Neonatology, First floor,
WCH block, JIPMER, Dhanvantri nagar, Puducherry
Pondicherry
PONDICHERRY |
9962653294
dr.ushaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Observational Studies |
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
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Day(s) |
| Age To |
24.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates born less than 31 + 0 weeks of gestation who are on full feeds and predominantly on mothers’ own milk and their mothers |
|
| ExclusionCriteria |
| Details |
Preterm neonates who expired before 2 weeks of life |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the agreement between protein intake using breast milk analyser measurements and the fixed protein content as per unit nutrition audit during week 4 (22 to 25 days) of life. |
Week 4(22-25 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the protein, fat, carbohydrate, and energy content by a milk analyser in week 2 (10 to 14 days) of life |
Week 2(10-14 days) |
| To compare protein, fat, carbohydrate, and energy composition of the milk samples between mothers with and without any co-morbidities |
Week 2(10-14 days)
Week 4(22-25 days) |
| To study the average calorie and protein intake per day from second week till discharge from the unit nutrition chart (updated weekly) |
Week 2 till discharge |
| To correlate weight delta z score from birth to discharge and the milk energy and protein content at around second week and fourth week of life |
Week 2(10-14 days)
Week 4(22-25 days) |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
15/09/2025 |
| 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
|
The study will be conducted at the tertiary neonatal care unit, JIPMER, Puducherry for a period of 2 years. Preterm infants delivered before 31 weeks of gestation will be enrolled after getting informed written consent from the parents after 10 days of life. Data on mother’s details and perinatal details will be collected. Data on neonatal course will be prospectively collected till discharge. 5ml breast milk will be collected on Day 10-14, Day 22-25 and analysis for macronutrient composition will be done using breastmilk analyser. This data will be compared with the standard content used for routine nutrition audit at postnatal weeks 2 and 4. |