By InvitationPhase 1

Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates

Egypt60 participantsStarted 2025-07-25

Plain-language 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 .

Who can participate

Age range

2 Weeks – 3 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hemoglobin concentration

Timeframe: Baseline before start of oral iron therapy,after that monthly for three months .

Serum ferritin level

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.

Serum hepcidin level

Timeframe: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.

Serum iron level

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.

Total iron-binding capacity (TIBC)

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.

Transferrin saturation

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.

Trial details

NCT IDNCT07667205

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-25

View on ClinicalTrials.gov More Iron Deficiency Anemia in Preterm Neaonates trials

Plain-language summary

Who can participate

Age range

2 Weeks – 3 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Hemoglobin concentration

Timeframe: Baseline before start of oral iron therapy,after that monthly for three months .

Serum ferritin level

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.

Serum hepcidin level

Timeframe: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.

Serum iron level

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.

Total iron-binding capacity (TIBC)

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.

Transferrin saturation

Timeframe: Baseline before starting of oral iron therapy, after that at the end of study after three months.