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 .
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- Ain Shams University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Aktiv komparator: 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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Aktiv komparator: -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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hemoglobin concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- FMASU MD 144/2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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Kliniske forsøg med Daily oral ferrous ion
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