CTRI

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CTRI Number

CTRI/2024/03/063820 [Registered on: 08/03/2024] Trial Registered Prospectively

Last Modified On:

22/02/2024

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Other

Public Title of Study

A follow up study to assess the effect of interventions from preconception to early childhood on neurodevelopment at 4-6 years

Scientific Title of Study

Multi-domain interventions from preconception to early childhood and neurodevelopment at 4-6 years

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 Ravi Prakash Upadhyay
Designation	Scientist
Affiliation	Society for Applied Studies
Address	45 Kalu Sarai South DELHI 110016 India
Phone	01146043751
Fax	01146043756
Email	ravi.upadhyay@sas.org.in

Details of Contact Person
Scientific Query

Name	Dr Ravi Prakash Upadhyay
Designation	Scientist
Affiliation	Society for Applied Studies
Address	45 Kalu Sarai South DELHI 110016 India
Phone	01146043751
Fax	01146043756
Email	ravi.upadhyay@sas.org.in

Details of Contact Person
Public Query

Name	Dr Sunita Taneja
Designation	Senior Scientist
Affiliation	Society for Applied Studies
Address	45 Kalu Sarai South DELHI 110016 India
Phone	01146043751
Fax	01146043756
Email	sunita.taneja@sas.org.in

Source of Monetary or Material Support

Thrasher Research Fund, USA

Primary Sponsor

Name	Society for Applied Studies
Address	Society for Applied Studies, 45, Kalu Sarai, Near IIT Delhi, South Delhi-110016, India
Type of Sponsor	Other [Not for profit research organization]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ravi Prakash Upadhyay	Society for Applied Studies	680, Gali No-5, Nai Basti, Devli Village, Khanpur,New Delhi-110062 South DELHI South DELHI	01146043751 01146043756 ravi.upadhyay@sas.org.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Centre for Health Research and Development, Society for Applied Studies Ethics Review Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Children with 4 to 6 years of completed age

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Comparator	Receiving standard care through government programs from preconception till child age 24 months
Intervention	Intervention	Receiving package of health, nutrition, environmental hygiene and psychosocial care from preconception till child age 24 months

Inclusion Criteria

Age From	4.00 Year(s)
Age To	6.00 Year(s)
Gender	Both
Details	Children who participated in primary trial(CTRI/2017/06/008908) and whose families consent to participate in the follow up study.

ExclusionCriteria

Details

Non-consent to participate in the follow up study
- Those with severe illness requiring prolonged hospital admission.
- Those with documented neuro-psychological ailment(s)
- Those with documented visual problems (for eye-tracking assessments)

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Cognition (IQ; intelligence quotient) and higher executive functions	At 4 to 6 years of completed age

Secondary Outcome

Outcome	TimePoints
School readiness	At 4 to 6 years of completed age
Language performance	At 4 to 6 years of completed age
Psychosocial and emotional behavior	At 4 to 6 years of completed age
Visual working memory and attention (using eye tracking based assessment)	At 4 to 6 years of completed age
Quality of stimulation and learning opportunities at home	At 4 to 6 years of completed age

Target Sample Size

Total Sample Size="1052"
Sample Size from India="1052"
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)

01/04/2024

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="2"
Months="6"
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

Substantial number of under-5 children in low resource settings are documented to be at risk of developmental deficits. Even though it is established that the etiology is multi-factorial, previous studies have largely focused on standalone interventions delivered in specific phases of life i.e., either pregnancy or postnatal or a combination and found small to modest improvements on child neurodevelopment. Effects of additional intervening in the period prior to conception (pre-conception period) are largely unstudied and so is the impact of a package of interventions that address majority of the modifiable risk factors for poor development. Our recent trial (WINGS) (CTRI/2017/06/008908) showed that a package of health, nutrition, psychosocial care, and WaSH interventions encompassing preconception, pregnancy and early childhood periods leads to substantial improvement in neurodevelopmental outcomes at 24 months of age (https://pubmed.ncbi.nlm.nih.gov/38165408/).
The present study will follow up children, enrolled in the previously conducted WINGS trial, until their pre-school age (4-6 years) and assess their neurodevelopment.