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Assessment of the effect of early vs routine Iron Supplementation on iron store and growth in term infants at 1 year

Phase 3
Conditions
Health Condition 1: null- Term well infants at 6 weeks
Registration Number
CTRI/2017/09/009904
Lead Sponsor
PGIMER
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
300
Inclusion Criteria

1.Term infants (born after 37 completed weeks of gestation by USG dating or LMP whichever applicable)

2.Appropriate for gestational age (as per revised Fentonâ??s chart 2013)

3.Small for gestational age (birth weight <10th percentile as per revised Fentonâ??s chart 2013

4.Parents consenting to follow up till 1 year

5.Parents residing within 100 kilometres of Chandigarh

Exclusion Criteria

1.H/o blood product transfusion prior to study enrolment

2.Severe birth asphyxia defined as 1 minute Apgar score 0-3 with or without mod to severe HIE

3.Severe sepsis with septic shock

4.Suspect haematological disorders (haemolytic jaundice, Rh isoimmunisation)

5.Infants with chronic diseases like congenital heart disease, cholestatic jaundice and suspected liver disease, suspected or diagnosed renal tubular acidosis, suspected or diagnosed inborn errors of metabolism

6.Suspected or proven chromosomal abnormalities.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Proportion of infants with Iron Deficiency Anemia. at 6 months and 1 year in 2 groupsTimepoint: 1.Proportion of infants with Iron Deficiency Anemia. at 6 months and 1 year in 2 groups
Secondary Outcome Measures
NameTimeMethod
Growth in terms of height (in cm), weight (in kg) and OFC (in cm)Timepoint: 6 months and 1 year
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