Iron Deficiency Anemia in Preterm Neaonates
Conditions
Brief summary
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 .
Detailed description
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.
Interventions
DRUGDaily oral ferrous ion
Will receive oral ferrous iron
DRUGDaily oral liposomal iron
Will receive Daily oral liposomal iron
DRUGOral liposomal iron every other day
Will receive Oral liposomal iron every other day
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 3 Weeks
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin concentration | Baseline before start of oral iron therapy,after that monthly for three months . | Hemoglobin level measured in g/dL to assess the effect of daily versus every-other-day liposomal iron supplementation in preterm neonates. |
| Serum ferritin level | Baseline before starting of oral iron therapy, after that at the end of study after three months. | Serum ferritin concentration measured in ng/mL to assess iron stores |
| Serum hepcidin level | Before start oral iron therapy,after that daily for three days after start of oral iron therapy. | Serum hepcidin concentration measured in ng/mL. |
| Serum iron level | Baseline before starting of oral iron therapy, after that at the end of study after three months. | Serum iron concentration measured in µg/dL. |
| Total iron-binding capacity (TIBC) | Baseline before starting of oral iron therapy, after that at the end of study after three months. | Total iron-binding capacity measured in µg/dL. |
| Transferrin saturation | Baseline before starting of oral iron therapy, after that at the end of study after three months. | Transferrin saturation measured as a percentage (%). |
Countries
Egypt
Outcome results
None listed