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Iron therapy for very low birth weight infants

Early versus late enteral prophylactic iron supplementation in very low birth weight newborn infants: A randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/01/003277
Enrollment
112
Registered
2013-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Very low birth weight infants at 2 weeks of age

Interventions

Intervention1: Iron at 2 weeks of age: In this group, iron (in the form of colloidal ferric hydroxide) in the dose of 2 mg/kg/day of elemental iron PO once daily mixed with expressed breast milk sha

Sponsors

JIPMER Institute Research Grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: To evaluate whether early oral iron supplementation at 2weeks of age would improve the iron status of preterm very low birth weight infants at postnatal age of 12 weeks, in comparison to starting iron supplementation at 6 weeks of life

Exclusion criteria

Exclusion criteria: a. Major congenital anomalies b. Rh hemolytic disease or ABO hemolytic disease c. Twin to twin transfusion d. Gestational age e. Refusal to give consent

Design outcomes

Primary

MeasureTime frame
To evaluate serum ferritin levels in preterm very low birth weight infants receiving early enteral iron supplementation in comparison with late iron supplementationTimepoint: Serum Ferritin ,Red cell indices at 2 weeks,6 weeks and at 12 weeks . CRP at 12 weeks

Secondary

MeasureTime frame
a. Hematological parameters [hemoglobin, iron, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) and reticulocyte counts)] at 6 weeks and 12 weeks of postnatal life in both the groups. b. Incidence of blood transfusion requirement till 12 weeks postnatal age in both the groups. Timepoint: 2,6,12 weeks

Countries

India

Contacts

Public ContactVISHNU BHAT B

JIPMER

emailrojojoy@gmail.com8903139893

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 10, 2026