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Clinical Trials/CTRI/2017/09/009904
CTRI/2017/09/009904
Recruiting
Phase 3

A randomized controlled trial to assess the effect of early vs routine Iron Supplementation on iron store and growth in term small for gestational age (SGA) and appropriate for gestational age (AGA) infants at 1 year

PGIMER0 sites300 target enrollmentTBD
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ConditionsHealth Condition 1: null- Term well infants at 6 weeks

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Term well infants at 6 weeks
Sponsor
PGIMER
Enrollment
300
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
PGIMER

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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