Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daily oral ferrous ion, Daily oral liposomal iron, Oral liposomal iron every other day.
- Who it may be relevant to
- Registry conditions: Iron Deficiency Anemia in Preterm Neaonates. Basic parameters: 2 Weeks — 3 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Daily oral ferrous ion
Will receive oral ferrous iron - Drug Daily oral liposomal iron
Will receive Daily oral liposomal iron - Drug Oral liposomal iron every other day
Will receive Oral liposomal iron every other day
Primary outcome measures
- Hemoglobin concentration [Time frame: Baseline before start of oral iron therapy,after that monthly for three months .]
- Serum ferritin level [Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.]
- Serum hepcidin level [Time frame: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.]
- Serum iron level [Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.]
- Total iron-binding capacity (TIBC) [Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.]
- Transferrin saturation [Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Ain shams university — Cairo
Identifiers
NCT: NCT07667205 · FMASU MD 144/2025