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 .
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: 1. The bottle should be shaken well for at least 30 secend . 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
Will receive oral ferrous iron
Will receive Daily oral liposomal iron
Will receive Oral liposomal iron every other day
Ain shams university
Cairo, Egypt
Hemoglobin concentration
Hemoglobin level measured in g/dL to assess the effect of daily versus every-other-day liposomal iron supplementation in preterm neonates.
Time frame: Baseline before start of oral iron therapy,after that monthly for three months .
Serum ferritin level
Serum ferritin concentration measured in ng/mL to assess iron stores
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Serum hepcidin level
Serum hepcidin concentration measured in ng/mL.
Time frame: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.
Serum iron level
Serum iron concentration measured in µg/dL.
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Total iron-binding capacity (TIBC)
Total iron-binding capacity measured in µg/dL.
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Transferrin saturation
Transferrin saturation measured as a percentage (%).
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
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