Skip to content

Effect of Integrated Nutrition, Health, Care and Support Interventions delivered to small babies during infancy, on growth and neurodevelopment

Impact of an integrated health, nutrition and early child stimulation and responsive care intervention package delivered to preterm or term small for gestational age babies during infancy on growth and neurodevelopment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037881
Enrollment
2600
Registered
2021-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Infants (0-12 m):Health and care seeking: Educate mother and family members to identify danger signs and seek appropriate and early care for illness. Management of illness. Intervent

Sponsors

Dr Sunita Taneja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Preterm ( < 37 weeks of gestation) or term SGA (birth weight for gestational age below the 10th percentile based on INTERGROWTH criteria) infants and their mothers. - Dating scan done within 20 weeks of gestation. - Caregiver consents to participate in the study.

Exclusion criteria

Exclusion criteria: - Major congenital malformations - Mother and baby intend to leave the study area within the next 12 months -Baby or mother hospitalized after birth for more than 14 days

Design outcomes

Primary

MeasureTime frame
Attained weight Attained weight for age Z score Timepoint: 12 months 12 months

Secondary

MeasureTime frame
Infants: Attained length, length for age, weight for length, mid upper arm circumference (MUAC) and head circumference, proportion stunted, wasted and underweightTimepoint: 6 and 12 months;Attained weight, weight for age z-scoresTimepoint: 6 months;Weight and length velocitiesTimepoint: Between birth and 6 months 6 and 12 months;Composite cognitive, language, motor, socio-emotional, temperament and HOME scoresTimepoint: 12 months;Hemoglobin and micronutrient status (Vitamin A, D, B12, Zinc, Iron, Folate, Selenium) in a sub-sampleTimepoint: 12 months;DeathTimepoint: Birth to 12 months;Possible serious bacterial infections/severe infectionsTimepoint: 1 month;Diarrhea and pneumonia Hospitalization for illness Household total expenditure Timepoint: Birth to 12 months Birth to 12 months 6 and 12 months (for last 6 months) ;Mothers BMI and MUAC Depressive symptoms Timepoint: 2,6 and 12 months 2,6 and 12 months ;Infants: Overweight or obesity Mean Global Scale for Early Development score (D score) Dietary assessment in a sub sample Timepoint: 12 months 6 & 12 months 9 & 12 months;Mothers Dietary assessment in a sub sampleTimepoint: 3 & 6 months

Countries

India

Contacts

Public ContactDr Ranadip Chowdhury

Centre for Health Research and Development, Society for Applied Studies

sunita.taneja@sas.org.in01146043751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jul 29, 2026