Iron Metabolism in Small Pre Term Newborns - Full Text View

Purpose

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.

Condition	Intervention
Preterm Iron Metabolism Iron Overload	Drug: Iron preparation

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Iron Metabolism in Small Pre Term Newborns

Resource links provided by NLM:

MedlinePlus related topics: Iron Premature Babies

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Assessment of the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)and identify which preterm infants are at risk for iron deficiency or iron overload.

Estimated Enrollment:	50
Study Start Date:	October 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Iron suplementation 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	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: Before starting iron supplementation (maximum one week before). 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). Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation).

Arms

Assigned Interventions

Experimental: Iron suplementation

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

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:

Before starting iron supplementation (maximum one week before).
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).
Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation).

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Very Low Birth Weight and / or borne at 30 weeks or less of gestational age that are scheduled to receive enteral iron supplementation as part of the standard protocol currently used by the Neonatal Intensive Care Unit.
Birth weight will be not an inclusion or exclusion criteria for preterms born at 30 weeks or less.

Exclusion Criteria:

Major physical anomalies,
renal or cardiac diseases,
newborns that underwent major surgery during the study period,
acute or chronic fetal blood loss,
hemolytic anemia,
refusal to receive parental consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443195

Contacts

Contact: Ariel Koren, MD

972-4-6495576 ext 5576

koren_a@clalit.org.il

Locations

Israel
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center	Recruiting
Afula, Israel, 18101
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il
Sub-Investigator: Ariel Koren, MD
Principal Investigator: Carina Levin, MD

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information

No publications provided

Responsible Party:	Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT01443195 History of Changes
Other Study ID Numbers:	0035-11-EMC
Study First Received:	September 27, 2011
Last Updated:	February 18, 2013
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013