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Enrolling by Invitation

NCT Number: NCT07667205

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 .

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Key information

Conditions

Iron Deficiency Anemia in Preterm Neaonates

Age range

2 week–3 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain shams university

Cairo, Egypt

About this study

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 .

  • Administration of the iron thrapy:
  • The bottle should be shaken well for at least 30 secend .
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily oral ferrous ion

Drug

Will receive oral ferrous iron

Daily oral liposomal iron

Drug

Will receive Daily oral liposomal iron

Oral liposomal iron every other day

Drug

Will receive Oral liposomal iron every other day

Primary outcomes

  1. Hemoglobin concentration

    Time frame: 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.

  2. Serum ferritin level

    Time frame: 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

  3. Serum hepcidin level

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

    Serum hepcidin concentration measured in ng/mL.

  4. Serum iron level

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

    Serum iron concentration measured in µg/dL.

  5. Total iron-binding capacity (TIBC)

    Time frame: 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.

  6. Transferrin saturation

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

    Transferrin saturation measured as a percentage (%).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.