Iron Metabolism in Small Pre Term Newborns

NCT01443195 | Unknown

• 1 other identifier: 0035-11-EMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload.

  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.

  One year

Study Arms (1)

Iron suplementation

EXPERIMENTAL

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

Interventions

Iron preparation DRUG

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).

Iron suplementation

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Premature Birth; Iron Overload

Interventions

Iron, Dietary

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Iron Compounds; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Dpt B and Pediatric Hematology Unit

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 29, 2011
• Study Start: October 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

IL (1)