to Assess the Effect of Early vs Routine Iron Supplementation on Iron Store and Growth in Term Infants

• Status: Unknown status
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Term infants (Small for Gestational Age and Appropriate for Gestational Age) would be randomized to receive oral iron supplementation from 6 weeks and 6 months. Growth in terms of Occipitofrontal circumference, length and weight would be monitored at 6 weeks, 6 months and 1 year of age. Hemoglobin, RBC (Red blood corpuscles) indices and ferritin would be monitored at 6 months and 1 year of age.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Deepanjan Bhattacharya
• Collaborator: Postgraduate Institute of Medical Education and Research
• Treatments: Iron

Criteria

Inclusion Criteria:

• Term infants (born after 37 completed weeks of gestation by USG dating or LMP and postnatally by New ballard scoring whichever applicable)

• Appropriate for gestational age (as per revised Fenton's chart 2013)

• Small for gestational age (birth weight <10th percentile as per revised Fenton's chart 2013) - Parents consenting to follow up till 1 year

• Parents residing within 100 kilometres of Chandigarh

Exclusion Criteria:

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

2. Neonatal jaundice due to hemolytic anemia

3. Severe birth asphyxia defined as 1 minute Apgar score 0-3 with or without moderate to severe HIE (Hypoxic Ischemic Encephalopathy).

4. Severe sepsis with septic shock

5. Suspect haematological disorders

6. 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

7. Suspected or proven chromosomal abnormalities.