Complementary feeding in preterm neonates

A randomized controlled trial of complementary feeding at chronological age of 6 months vs corrected age of 6 months in preterm neonates - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061421

Enrollment

200

Registered

2024-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Complementary feeding at chronological age of 6 months: Complementary feeding to be started at chronological age of 6 months Control Intervention1: Complementary feeding at corrected ag

Eligibility

Inclusion criteria

Inclusion criteria: 1) Neonates 2) Attained a weight of at least 4.5 kg 3) Readiness for semi solid food as assessed by partial neck holding, hand to mouth behaviour , lip locking, absence of extrusion reflex, chewing.(any 2-3).

Exclusion criteria

Exclusion criteria: 1) Infants with suspected or proven TORCH infection 2) Newborns with chronic diseases which will hinder growth and developments a. Congenital heart disease requiring diuretics or on fluid restriction for control of congestive cardiac failure b. Cholestatic jaundice and suspected liver disease c. Suspected or diagnosed renal tubular acidosis d. Suspected or diagnosed inborn errors of metabolism e. Suspected or proven syndromic babies 3) Infants who have already been given a trial of semisolids prior to enrolment 4) Infants whose parents will not be able to come for frequent follow ups 5) Infants whose parents will be unable to maintain a daily dietary record due to lack of understanding or education as assessed by the primary investigator.

Design outcomes

Primary

Measure	Time frame
Primary outcomes 1.Z scores of Weight, length and HC at 12 months chronological age and corrected age 2.Proportion of underweight, stunting and wasting at CA 12 months Secondary outcomes 3. S. Calcium, S.phosphorous, alkaline phosphatase levels and proportion of Vitamin D deficiency at 12 months of chronological age in 2 groups . 4. Proportion of iron deficiency ( based on Hb, RBC indices, serum ferritin) at 12 months of chronological age in 2 groups 5.MeDQ and MoDQ as per DASII scores at 18 months corrected age. 6. Neurodevelopment impairment (NDI) at 12 months of corrected age 7.Total episodes of diarrhoea, wheezing ,skin atopy or other causes of admission during the study period 8.All cause mortality at 1 year Timepoint: 18 months corrected age	—

Measure

Time frame

Primary outcomes 1.Z scores of Weight, length and HC at 12 months chronological age and corrected age 2.Proportion of underweight, stunting and wasting at CA 12 months Secondary outcomes 3. S. Calcium, S.phosphorous, alkaline phosphatase levels and proportion of Vitamin D deficiency at 12 months of chronological age in 2 groups . 4. Proportion of iron deficiency ( based on Hb, RBC indices, serum ferritin) at 12 months of chronological age in 2 groups 5.MeDQ and MoDQ as per DASII scores at 18 months corrected age. 6. Neurodevelopment impairment (NDI) at 12 months of corrected age 7.Total episodes of diarrhoea, wheezing ,skin atopy or other causes of admission during the study period 8.All cause mortality at 1 year Timepoint: 18 months corrected age

—

Secondary

Measure	Time frame
serum biochemical profile , vitamin D , IRON status, DASII scoresTimepoint: 18 months corrected age	—

Countries

India

Contacts

Public ContactKanya Mukhopadhyay

Professor, Neonatal unit, Dept of Pediatrics, PGIMER,Chandigarh

kanyapgi@gmail.com9914208317

Outcome results

None listed

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