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Trial of early vs late weaning in preterm infants

Randomised controlled trial of early weaning versus late weaning in predominantly formula fed preterm infants in terms of growth, neurodevelopmental, haematological and biochemical parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/11/006367
Enrollment
100
Registered
2015-11-18
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 at or less than 34 weeks of gestation predominantly formula/ top fed at 4 months of chronological age

Interventions

Intervention1: Early weaning group: Introduction of complementary foods at 4 months of chronological age Control Intervention1: late weaning: introduction of solid foods after 6 months of chronologica

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 4 months of chronological age, weight atleast less than 3.5kg, partial head control

Exclusion criteria

Exclusion criteria: Chronic illnesses like BPD, congenital heart disease, suspected or proven chronic liver/ metabolic diseases,TORCH infection, Parents/ family incapable of maintaining a diet diary, Parents unable to come for follow up

Design outcomes

Primary

MeasureTime frame
Growth(weight, length and OFC), hematological(hemoglobin and RBC indices), metabolic( S.calcium, S.phosphate and S ALP levels, plasma Vitamin D), neurodevelopmentTimepoint: Growth(weight, length and OFC), hematological(hemoglobin and RBC indices), metabolic( S.calcium, S.phosphate and S ALP levels, plasma Vitamin D), neurodevelopment

Secondary

MeasureTime frame
Diarrheal illnesses requiring OPD visit/ admission, any suspected or proven atopy, any wheezing episode requring OPD visit/ hospital admissions,Timepoint: till 1 year of chronoloigcal age

Countries

India

Contacts

Public ContactDrSuja Mariam

Newborn unit PGIMER, Chandigarh

kanyapgi@gmail.com7087008317

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026