Skip to content

Comparison of serum ferritin level guided and standard practice of oral iron supplementation in very preterm neonates

Serum Ferritin level guided vs Standard practice of oral iron supplementation in very preterm neonates hospitalized in tertiary care NICU - A Prospective randomised control superiority trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066651
Enrollment
206
Registered
2024-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Serum ferritin level monitoring: Oral iron suppllimentation guided by serum ferritin level monitoring from around 2 - 3 weeks of life till discharge from hospital Control Intervention1:

Sponsors

Rainbow Children s Hospital and Birthright .
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates less than 32 weeks of gestational age hospitalized in NICU

Exclusion criteria

Exclusion criteria: Preterm neonates whom iron supplementation is deferred because as in 1.Those with an active, culture-proven infection, or positive sepsis screen 2.A major surgical malformation of gut 3.Neonates in whom bowel resection is done 4.Neonates with Stage II and III Necrotizing enterocolitis 5.Cyanotic congenital heart disease 6.Neonates with hemoglobinopathies. 7.Neonates diagnosed with inflammatory conditions like hemophagocytic lymphohistiosis (HLH).

Design outcomes

Primary

MeasureTime frame
Determining the optimal age (in day of life) for initiation of oral iron supplementation at the time of full feed achievement and at 2 weeks of life (whichever is later) by serum ferritin monitoring compared with the standard practice.Timepoint: 2 weeks to 4 weeks

Secondary

MeasureTime frame
1.Total quantum (in mg) of oral iron supplemented during the NICU stay. 2.Number of LRBC transfusions administered during their stay in NICU. 3.Mean serum ferritin levels at the time of discharge in both groups. Timepoint: At discharge (8-10 weeks)

Countries

India

Contacts

Public ContactSunil Hanasi

Rainbow Childrens Hospital and Birthright . Banjara hills Road number 2 . Hyderabad

nalini199@gmail.com9535573835

Outcome results

None listed

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