| CTRI Number |
CTRI/2025/12/098697 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Poor growth in very small babies after discharge from a major hospital in Delhi |
|
Scientific Title of Study
|
Growth Faltering in Very Low Birth Weight Babies Discharged from a Tertiary Care Hospital in Delhi. |
| 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 PRIYA SINGH |
| Designation |
PG 1st Year |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7289846913 |
| Fax |
|
| Email |
dr.priyasingh022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANIKA SULANIA |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number- 363, Department of Community Medicine, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9873743493 |
| Fax |
|
| Email |
ani.sulania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYA SINGH |
| Designation |
PG 1st Year |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7289846913 |
| Fax |
|
| Email |
dr.priyasingh022@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
DR PRIYA SINGH |
| Address |
Department of Community Medicine, Maulana Azad Medical College |
| 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 Priya Singh |
Maulana Azad Medical College |
Areas Within 10kms radius of College, Bahadur Shah Zafar Marg, New Delhi- 110002
Central
DELHI |
07289846913
dr.priyasingh022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P071||Other low birth weight newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Month(s) |
| Gender |
Both |
| Details |
The study included very low birth weight (VLBW) babies, defined as those with a birth weight of less than 1500 grams, who were admitted to or discharged from Lok Nayak Hospital in Delhi, regardless of their gestational age. Eligible participants were required to reside within approximately 10 kilometers of the hospital and to remain in the study area or within Delhi for at least six months during their postnatal period. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of very low birth weight babies who fail to thrive/ showing growth faltering after discharge from NICU of Lok Nayak Hospital, Delhi at 5 months of age on postnatal follow-up.faltering after discharge from NICU of Lok Nayak Hospital, Delhi at 5 months of age on postnatal follow-up. |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association of grades of growth faltering in VLBW babies with maternal, socio-economic, & nutritional factors in the community settings.
2.Mean number of visits for Home-Based Newborn Care by ASHAs & the services provided by them.
3.Mean score of Knowledge, Attitudes, & Practices (KAP) among caregivers regarding infant feeding practices & post-discharge care & their association with baby’s growth.
4.Association of Growth Faltering with Health seeking behaviour among mothers/caregivers of these VLBW babies.
|
Baseline, 1month & 5 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/12/2025 |
| 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="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
|
Primary Purpose
The purpose of this protocol is to assess the proportion of very low birth weight babies discharged from the Neonatal Intensive Care Unit of Lok Nayak Hospital in Delhi who show growth faltering by five months of age. The study also aims to identify maternal socioeconomic environmental and health related factors along with caregiver knowledge attitudes and practices that influence post discharge growth outcomes.
Study Hypothesis
A considerable number of very low birth weight infants will experience growth faltering at five months after discharge and this faltering will be linked to modifiable community based factors such as feeding practices health seeking behavior and availability of home based newborn care services. |