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Iron supplements in small babies during first year of life

Iron supplementation during early infancy in small-for-gestation low birth weight neonates: A placebo-controlled double-blind randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007958
Enrollment
200
Registered
2017-02-27
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- Hemodynamically stable , on full feeds, fit for discharge to home

Interventions

Intervention1: Iron: Iron group: Neonates randomized to Iron group will receive iron supplementation till completing 6 months of postnatal age. Iron supplementation will start at 2-4 weeks of postnata

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 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 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

Design outcomes

Primary

MeasureTime frame
MDI scores at 18 and 24 months by BSID III PDI scores at 18 and 24 months by BSID III Latency of Waveform V in Brainstem auditory evoked response at 6,18 and 24 months hematological parameters: S. Ferritin, Packed cell volume levls at 6 months of age.Timepoint: MDI scores at 18 and 24 months by BSID III PDI scores at 18 and 24 months by BSID III Latency of Waveform V in Brainstem auditory evoked response at 6,18 and 24 months hematological parameters: S. Ferritin, Packed cell volume levls at 6 months of age.—

Secondary

MeasureTime frame
): hematological parameters: S. Ferritin, Packed cell volume levls at 6 months of age.Timepoint: 6 months—

Countries

India

Contacts

Public ContactDr Suksham Jain

Government Medical College and Hospital,Sector 32-B Chandigarh,160030

dr.sukshamj@gmail.com09988901596

Outcome results

None listed

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