| CTRI Number |
CTRI/2025/08/093131 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To improve milk output in mothers of less than 32 weeks gestation babies
A quality improvement study” |
|
Scientific Title of Study
|
Improving the uptake of evidence based practices to increase milk output in mothers of
neonates born before 32 weeks gestation
A quality improvement 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 |
Ihina Tinna |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 838, 8th floor, Mother and Child Block, Department of Paediatrics, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9643306354 |
| Fax |
|
| Email |
ihinatinna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Agarwal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 838, 8th floor, Mother and Child Block, Department of Paediatrics, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9643306354 |
| Fax |
|
| Email |
ra.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ihina Tinna |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 838, 8th floor, Mother and Child Block, Department of Paediatrics, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
9643306354 |
| Fax |
|
| Email |
ihinatinna@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New delhi, India
Pin code- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Ansari Nagar East, New Delhi, India
Pin code 110029 |
| 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 Ihina Tinna |
All India Institute of Medical Sciences, New Delhi |
Room No 838, 8th floor, Mother and Child block, Division of Neonatology, Department of Paediatrics, AIIMS, Delhi
South
DELHI |
9643306354
ihinatinna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Mothers of babies born before 32 weeks gestation |
|
| ExclusionCriteria |
| Details |
Critically sick mothers admitted in obstetric intensive care unit
2. Retro-positive mothers who declined breastfeeding
3. Mothers with neonates having major congenital malformations requiring surgical
intervention and hence non establishment of exclusive breast feeding in the initial one week.
4. Mothers of sick neonates who are ineligible for implementation of EBPs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uptake of evidence based practices |
Day 28 of life of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Milk output |
Day 14 and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/08/2025 |
| 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="1"
Months="5"
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
|
Mother of all preterm neonates admitted in NICU will be screened for enrollment. The parents will be approached for consent after applying the inclusion and exclusion criteria. If consented, the primary investigator will apply a bundle of strategies to improve the uptake of evidence based practices to increase milk output in mothers. Result in form of uptake will be assessed and if does not meet the predefined level, reasons and hindrances will be assessed. Accordingly multiple PDSA cycles will be run till target is achieved. |