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To assess the benefits of early iron supplementation at 2 weeks post gestational age in preterm very low birth weight infants.

Single blinded parallel group interventional randomised control trial to assess the benefits of early iron supplementation at 2 weeks post gestational age in preterm very low birth weight infants. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087251
Enrollment
72
Registered
2025-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: P07- Disorders of newborn related to short gestation and low birth weight, not elsewhere classified

Interventions

Intervention1: MILTOFER Iron drops: 3ml/kg/day iron drops will be given at 2 weeks in early group and at 4 weeks in late intervention group Control Intervention1: MILTOFER DROPS: 3ml/kg/day iron drops

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: preterm less than 37 weeks, less than 1500gm, who have reached 100ml/kg/day by 2 weeks of age

Exclusion criteria

Exclusion criteria: o Babies with major congenital anomalies especially GI tract anomalies o multiple gestation o Rh incompatibility o ABO haemolytic diseases requiring exchange transfusion o neonates undergoing surgery o intraventricular haemorrhage o antepartum haemorrhage will be excluded. o Parents who refuse follow up

Design outcomes

Primary

MeasureTime frame
Reticulocyte Hemoglobin Equivalent will be measured at 8 weeks of life of the neonateTimepoint: At 8 weeks of life of the neonate—

Secondary

MeasureTime frame
Incidence of neonatal morbidities, haemoglobin level, anthropometric parameters and blood transfusion after inclusion in the study and at the end of 2 weeks.Timepoint: 2 weeks—

Countries

India

Contacts

Public ContactDr S R Fattepur

Karnataka Institute of Medical Sciences and Research Centre, KMCRI, Hubli

sshayan26@gmail.com9686034356

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026