| CTRI Number |
CTRI/2025/04/085556 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Upgrading Norms for Growth and Development Assessment of Indian Children (UNNATI) |
|
Scientific Title of Study
|
India Child Growth Standards Research Initiative: A Prospective Cohort Study to Develop Growth Standards in 0 to 24 months Indian Children |
| Trial Acronym |
UNNATI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Mukherjee |
| Designation |
Scientist F |
| Affiliation |
Indian Council of Medical Resarch |
| Address |
First floor, New Building, Clinical Studies & Trial Unit, Division of Development Research,
V Ramalingaswami Bhawan ICMR Headqauters Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9968408999 |
| Fax |
|
| Email |
aparna.sinha.deb@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amlin Shukla |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Resarch |
| Address |
Room No. 305, Division of Delivery Research
V Ramalingaswami Bhawan ICMR Headqauters Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
8447125128 |
| Fax |
|
| Email |
amlin.shukla@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Mukherjee |
| Designation |
Scientist F |
| Affiliation |
Indian Council of Medical Resarch |
| Address |
First floor, New Building, Clinical Studies & Trial Unit, Division of Development Research,
V Ramalingaswami Bhawan ICMR Headqauters Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9968408999 |
| Fax |
|
| Email |
aparna.sinha.deb@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research, New Delhi |
| Address |
ICMR Headquarters, Ansari Nagar, New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadhana Joshi |
Interactive Research School for Health Affairs (IRSHA) |
Bharati Hospital and Research centre, Satara Road, Dhankawadi
Pune
MAHARASHTRA |
8007945167
srjoshi62@gmail.com |
| Dr C Sai Ram |
National Institute of Nutrition (NIN) |
Jamai-Osmania
Hyderabad
TELANGANA |
9618774603
challa.sv@icmr.gov.in |
| Dr Samiran Bisai |
Sidho-Kanho-Birsha University |
P.O-Purulia Sainik School, Ranchi Road
Puruliya
WEST BENGAL |
9434021821
samiran.bisai@skbu.ac.in |
| Dr Sunita Taneja |
Society for Applied Studies (SAS) |
45, Kalu Sarai
New Delhi
DELHI |
9811206456
sunita.taneja@sas.org.in |
| Dr Pratibha Dwarkanath |
St. Johns Research Institute (SJRI) |
St. Johns National Academy of Health Sciences
Bangalore
KARNATAKA |
9880714118
pratibha@sjri.res.in |
| Dr Manoj Kumar Das |
The INCLEN Trust International and NEIGRIHMS |
F-1/5, Second Floor, Okhla Industrial Area, Phase I
New Delhi
DELHI |
9810203768
manoj@inclentrust.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| The INCLEN Trust International |
Approved |
| Institutional Ethical Committee National Institute of Nutrition (ICMR) |
Approved |
| Institutional Ethics Committee, Bharati Vidyapeeth Deemed University |
Approved |
| Sidho Kanho Birsha University |
Approved |
| Society for Applied Studies |
Approved |
| St Johns Research Institute, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Child Growth and Development |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Parental, Family and Environmental Criteria:
1. Spontaneously conceived term singleton birth with gestational age equal to or more than 37 completed weeks (259 days) and less than 42 completed weeks (294 days).
2. No significant illness diagnosed during pregnancy, such as severe anemia, pregnancy-induced hypertension, gestational diabetes mellitus, hypothyroidism, obesity, any chronic or severe medical illness.
3. No history of consumption of tobacco, alcohol, or other substance uses in any form during this pregnancy, and smoking inside the house by any family members.
4. 15 years or more of formal parental education.
5. Family willing for frequent contacts.
Child characteristics:
1. Adequate adherence to criteria for a healthy growth environment including exclusive breastfeeding for 6 months, appropriate complementary feeding, and all the components of the nurturing care framework to ensure healthy caregiving environment.
2. Appropriate body composition
|
|
| ExclusionCriteria |
| Details |
1. Congenital abnormalities that may affect growth such as congenital heart disease, neural tube defects based on antenatal USG or post-delivery clinical evaluation or any other major malformation.
2. Birth complications such as birth asphyxia, sepsis or any other morbidity that require longer hospital stay.
3. Any major illness diagnosed during the study period.
4. Major adverse environmental influences like child abuse.
5. Maternal death any time during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Growth standards for children from 0-24 months of age.
Weight for age (Z Score), Length for age (Z score), Weight for length (Z score), BMI for age and growth velocity charts will be developed |
Anthropometric data will be collected at Birth, 1-2,4,6,8 weeks of age and 3,4,5,6,7,8,9,10,11,12,14,16,18,20,22,24 months of age.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neuro-developmental assessment will be done by WHO-GSED (Global Scale for Early Development).
Growth Charts for Small for Gestational Age babies (0-24 months) Weight for age (Z Score), Length for age (Z score), Weight for length (Z score), BMI for age & growth velocity charts will be developed
|
Neuro-development assessment data will be collected at the following time points: 1, 3, 6, 9, 12, 15, 18, 21 & 24 months of age.
Assessment time-points will be similar for SGA & AGA babies
|
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
01/05/2025 |
| 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="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Healthy growth from conception through early life is crucial for laying a strong foundation for future physical health, work productivity, and cognitive capacity. Assessing children’s growth is crucial for evaluating the health and socioeconomic development of communities where they live. Currently, the most widely used standards for the assessment of growth and development of children are the World Health Organization growth standards based on the Multicenter Growth Reference Study (MGRS) conducted over 20 years ago. Since then, practices constituting an optimal environment for child growth have evolved. Also, the Indian data for WHO-MGRS study, collected from a single centre at South Delhi is not considered as representative of the Indian population by many critics. Therefore, a prospective cohort study with children from six regions of the country has been planned to measure childhood growth and development, from 0-24 months, in an environment without major biological, socio-behavioral, and economic constraints to growth. Other objectives of the study are to develop normative neurodevelopmental charts for Indian Children 0-24 months of age and growth curves for term Small for Gestational Age (SGA) babies from 0-24 months of age. Pregnant women <37 weeks of gestation (with dating ultrasound available) will be screened to rule out major biological, socio-behavioral and economic constraints to growth of fetus. The term infants born of such eligible women, with no major congenital anomalies or birth complications, will be enrolled after taking informed, written consent from parent/s. A total of 300 boys and 300 girls will be enrolled from 6 sites. The enrolled infants will be followed every fortnightly from birth till 2 months, monthly till 12 months and then bimonthly till 24 months of age to record the anthropometric indices such as weight, length, head circumference and mid upper arm circumference. Mothers/ care givers will be counselled on these visits about nurturing care framework that consists of good health, adequate nutrition, safety and security, responsive caregiving and opportunities for learning. WHO-GSED (Global Scale for Early Development- long and short forms) will be administered to all enrolled children to assess the development scores. The expected duration of the study is 3.5 years
|