| CTRI Number |
CTRI/2025/02/080975 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Attainment of Developmental Milestones Among Children Under Three Years in Urban Areas of Lucknow |
|
Scientific Title of Study
|
Attainment of Developmental Milestones Among Under-Three Years Children in Urban Lucknow: A Mixed Method 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 |
Shrinkhala Chaudhary |
| Designation |
Postgraduate Student |
| Affiliation |
K.S. Hedge Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health, K.S. Hedge Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6394609057 |
| Fax |
|
| Email |
ch.shrinkhala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prajwal Jupiter Lobo |
| Designation |
Assistant Professor |
| Affiliation |
K.S. Hedge Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health, K.S. Hedge Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8828224857 |
| Fax |
|
| Email |
prajwal.lobo@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prajwal Jupiter Lobo |
| Designation |
Assistant Professor |
| Affiliation |
K.S. Hedge Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health, K.S. Hedge Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8828224857 |
| Fax |
|
| Email |
prajwal.lobo@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| KS Hegde Medical Academy, Nitte (Deemed to be University), Dakshina Kannada,
Karnataka, India
Pincode-575018 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Swarna Rastogi |
K.S. Hedge Medical Academy |
Department of Public Health, K.S. Hedge Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA |
9427346078
dr.swarnarastogi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K.S. Hedge Medical Academy, Nitte (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Developmental Milestones |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
Caregivers of children aged 2 to 36 months registered at Anganwadi Centres in urban Lucknow |
|
| ExclusionCriteria |
| Details |
Caregiver who will be sick at the time of visit |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Developmental milestone status and to identify factors associated with the developmental milestone status among children aged 2-36 months registered in Anganwadi Centres of Urban Lucknow |
Developmental milestone status and to identify factors associated with the developmental milestone status among children aged 2-36 months registered in Anganwadi Centres of Urban Lucknow |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Influence of caregiving practices on developmental milestones status
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="622"
Sample Size from India="622"
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)
|
03/03/2025 |
| 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="0"
Months="2"
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
|
This study aims to assess the factors influencing developmental milestone status and the role of caregiving practices among children aged 2-36 months in urban Lucknow. It follows a mixed-methods approach, incorporating a cross-sectional study for quantitative data collection and in-depth interviews for qualitative insights. The study will be conducted in Anganwadi Centres (AWCs) across two randomly selected zones of urban Lucknow. A total of 622 children will be included, with developmental milestones assessed using the Trivandrum Developmental Screening Chart (TDSC). Socioeconomic and demographic factors will also be examined. Quantitative data will be analyzed using Jamovi version 2.3.28. Descriptive statistics, including mean, standard deviation, median, and interquartile range (IQR), will be used based on data normality. Frequency distribution and percentages will be applied for categorical variables. The chi-square test will assess associations between categorical variables, with a statistical significance level set at p<0.05. For qualitative analysis, in-depth interviews with caregivers of children with both normal and delayed milestones will be conducted until information saturation. Audio recordings will be transcribed, translated, and analyzed using thematic content analysis. Data collection is scheduled from March to April 2025, with results expected to provide valuable insights into the impact of caregiving practices on child development, informing future interventions to support early childhood growth. |