Iron supplements in small babies during first year of life

Not Applicable

Not yet recruiting

• Conditions: Health Condition 1: null- Hemodynamically stable , on full feeds, fit for discharge to home

• Registration Number: CTRI/2017/02/007958
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Neonates born at Government Medical College Hospital will be eligible for enrolment if they fulfill all of the following criteria:

1.Gestation at birth >=35completed weeks

2.Birth weight less than 2500 g

3.Weight less than 3rd percentile for gestation at birth as per Intergrowth charts

4.Healthy neonate accepting breast feeds/ expressed breast milk

Exclusion Criteria

Neonates with any of the following criteria will be excluded:

1.Birth weight less than 1500 g

2.Major congenital malformation

3.Hearing abnormality on screening BERA test

4.Not accepting orally by end of first week of life

5.Severe birth asphyxia, APGAR <4 at 5 minutes

6.Rhesus incompatibility

7.Contraindication to start iron at 2-4 weeks (severe sepsis, shock)

8.Neonatal Meningitis

9.Inborn errors of metabolism

10.Symptomatic hypoglycemia

11.Inability to complete followup

12.Twin to Twin transfusion

13.Hemoglobin <11g/dl or raised CRP at baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified