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Iron Metabolism in Small Pre Term Newborns

NCT01443195 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-11-01

No results posted yet for this study

Summary

Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may persist into adulthood and may not be corrected by restoration of normal iron levels.

Iron overload remains a significant concern in preterm infants because they have low levels of iron-binding proteins and immature antioxidant systems.

The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the iron supplementation practice for VLBW preterm infants as implemented in the Neonatal Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.

Conditions

  • Preterm
  • Iron Metabolism
  • Iron Overload

Interventions

DRUG

Iron preparation

Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal. Serum samples will be obtained at 3 different times: 1. Before starting iron supplementation (maximum one week before). 2. At the beginning of iron supplementation in order to assess early signs of erythropoiesis, iron overload or free iron (day 4 - 7 days of supplementation). 3. Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation).

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443195 on ClinicalTrials.gov