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 .

Study Overview

• Status: Enrolling by invitation
• Conditions: Iron Deficiency Anemia in Preterm Neaonates
• Intervention / Treatment: Drug: Daily oral ferrous ion; Drug: Daily oral liposomal iron; Drug: Oral liposomal iron every other day

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care group will receive daily oral ferrous iron; will receive daily oral ferrous iron	Drug: Daily oral ferrous ion; Will receive oral ferrous iron
Active Comparator: Daily Liposomal group: will receive daily oral liposomal iron.; will receive daily oral liposomal iron.	Drug: Daily oral liposomal iron; Will receive Daily oral liposomal iron
Active Comparator: -Every other day liposomal group: will receive oral liposomal iron every other day.; will receive oral liposomal iron every other day.	Drug: Oral liposomal iron every other day; Will receive Oral liposomal iron every other day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin concentration	Hemoglobin level measured in g/dL to assess the effect of daily versus every-other-day liposomal iron supplementation in preterm neonates.	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	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.	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.	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.	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 (%).	Baseline before starting of oral iron therapy, after that at the end of study after three months.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2025
• Primary Completion (Actual): July 25, 2025
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: September 20, 2025
• First Submitted That Met QC Criteria: June 20, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD 144/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes