Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
6. Administration of the iron thrapy:
- The bottle should be shaken well for at least 30 secend .
- The dose is better to administrated in the morning at least one hour before fed.
4-The bottle should Stored in refrigerator for one month after opening of the bottles.
7.Follow up of the patient:
- Follow up of the patient will be done by phone calls every week .Drug compliance and monitoring of side effect will be recorded.
- All patients Will underwent clinical assessment every 4weeks at the outpatient neonatology clinic for 12 weeks ( total of 3 visits).
At each follow up visit:
Anthropometric measurements: body weight, length and occipito-frontal circumference will be measured and plotted on the Fenton growth chart for preterm neonates.
Compliance to the drug will be assessed and recorded Gastrointestinal side effect (e.g, vomiting, constipation, abdominal distension) will monitored weekly.
Laboratory investigation will be conducted as previously outlined.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Cairo, Egitto
- Ain Shams University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Preterm neonates Gestational age ≤ 34 weeks who can tolerate oral feeding.
- Brith weight <2500gm.
Exclusion Criteria:
- Major Surgical procedures.
- Major Chromosomal anomaly.
- Inborn error of metabolism.
- GIT anomalies.
- Neonatal sepsis.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Standard care group will receive daily oral ferrous iron
will receive daily oral ferrous iron
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Will receive oral ferrous iron
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Comparatore attivo: Daily Liposomal group: will receive daily oral liposomal iron.
will receive daily oral liposomal iron.
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Will receive Daily oral liposomal iron
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Comparatore attivo: -Every other day liposomal group: will receive oral liposomal iron every other day.
will receive oral liposomal iron every other day.
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Will receive Oral liposomal iron every other day
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hemoglobin concentration
Lasso di tempo: Baseline before start of oral iron therapy,after that monthly for three months .
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Hemoglobin level measured in g/dL to assess the effect of daily versus every-other-day liposomal iron supplementation in preterm neonates.
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Baseline before start of oral iron therapy,after that monthly for three months .
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Serum ferritin level
Lasso di tempo: Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Serum ferritin concentration measured in ng/mL to assess iron stores
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Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Serum hepcidin level
Lasso di tempo: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.
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Serum hepcidin concentration measured in ng/mL.
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Before start oral iron therapy,after that daily for three days after start of oral iron therapy.
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Serum iron level
Lasso di tempo: Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Serum iron concentration measured in µg/dL.
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Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Total iron-binding capacity (TIBC)
Lasso di tempo: Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Total iron-binding capacity measured in µg/dL.
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Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Transferrin saturation
Lasso di tempo: Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Transferrin saturation measured as a percentage (%).
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Baseline before starting of oral iron therapy, after that at the end of study after three months.
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- FMASU MD 144/2025
Piano per i dati dei singoli partecipanti (IPD)
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Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
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Prove cliniche su Daily oral ferrous ion
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Murdoch Childrens Research InstituteTerminato