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

Обзор

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 .

Подробное описание

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.

Вмешательства

• Препарат Daily oral ferrous ion
  Will receive oral ferrous iron
• Препарат Daily oral liposomal iron
  Will receive Daily oral liposomal iron
• Препарат Oral liposomal iron every other day
  Will receive Oral liposomal iron every other day

Первичные конечные точки

• Hemoglobin concentration [Срок оценки: Baseline before start of oral iron therapy,after that monthly for three months .]
• Serum ferritin level [Срок оценки: Baseline before starting of oral iron therapy, after that at the end of study after three months.]
• Serum hepcidin level [Срок оценки: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.]
• Serum iron level [Срок оценки: Baseline before starting of oral iron therapy, after that at the end of study after three months.]
• Total iron-binding capacity (TIBC) [Срок оценки: Baseline before starting of oral iron therapy, after that at the end of study after three months.]
• Transferrin saturation [Срок оценки: Baseline before starting of oral iron therapy, after that at the end of study after three months.]

Критерии участия

Критерии включения

• Preterm neonates Gestational age ≤ 34 weeks who can tolerate oral feeding.
• Brith weight <2500gm.

Критерии исключения

• Major Surgical procedures.
• Major Chromosomal anomaly.
• Inborn error of metabolism.
• GIT anomalies.
• Neonatal sepsis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Ain shams university — Cairo

Идентификаторы

NCT: NCT07667205 · FMASU MD 144/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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