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A clinical trial to study the effect of starting complementary food at 4 months compared to 6 months of age on growth of preterm infants born before 34 weeks of gestation.

Effect of initiation of complementary food at 4 months (17 weeks) of corrected age compared to 6 months (26 weeks) of corrected age on growth of preterm infants less than 34 weeks of gestation- A randomized, multisite trial - COPING trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003149
Enrollment
390
Registered
2012-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Preterm infants born at less than 34 completed weeks of gestation

Interventions

Intervention1: Initiation of complementary food at 4 months (17 weeks) of corrected age: Complementary food as per standard recommendations will be advised to be started at 4 months (17 weeks) of corr

Sponsors

Department Of Pediatrics AIIMS Delhi
Lead Sponsor
Dr Ramesh Agarwal
Collaborator
Dr VKPaul
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm infants born at less than 34 completed weeks of gestation with no major malformation or chromosomal or genetic abnormality 2. Residence within 60 km of the study hospitals and no plan to move away from the study region during the period of study

Exclusion criteria

Exclusion criteria: Infants requiring an initial hospital stay following birth beyond 40 weeks of postmenstrual age Infants initiated on complementary foods prior to 4 months (17 weeks) of corrected age

Design outcomes

Primary

MeasureTime frame
Weight for age z scoreTimepoint: 12 months of corrected age

Secondary

MeasureTime frame
Body composition using Dual Energy X-Ray Absorptiometry (DXA)Timepoint: At 12 months of corrected age;Bone mineral density using DXATimepoint: At 12 months of corrected age;Change in weight for age z scoreTimepoint: From 16 weeks to 6,9 and 12 months of corrected age;Metabolic and cardiovascular risk markers, i.e. Blood pressure, lipid profile, fasting blood glucose and insulinTimepoint: At 12 months of corrected age;Micronutrient status (iron and zinc)Timepoint: At 12 months of corrected age;Morbidities requiring physician visit and/or hospitalizationTimepoint: From the time of enrolment i.e.16 weeks of corrected age to 12 months of corrected age;Neurodevelopment using Developmental Assessment Scales for Indian Infants (DASII)Timepoint: At 12 months of corrected age

Countries

India

Contacts

Public ContactDr Shuchita Gupta

All India Institute of Medical Sciences, Delhi

ra.aiims@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 10, 2026