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 .
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte
- Ain Shams University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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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Comparateur actif: 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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Comparateur actif: -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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hemoglobin concentration
Délai: 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 .
|
|
Serum ferritin level
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- FMASU MD 144/2025
Plan pour les données individuelles des participants (IPD)
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Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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produit fabriqué et exporté des États-Unis.
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