Iron Status and Myelination in Premature Infants

Neurodevelopmental Outcome Clinical Trial

— Piron  

Official title:

Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684697
• Other study ID #: Piron Trial
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

Inclusion Criteria:

• Babies less than or equal to 33 weeks gestational age

Exclusion Criteria:

• Infants with cranio-facial malformations

• Torch infections

• Infants with hearing disorders

• Infants receiving erythropoietin

• Infants with subnormal vitamin E levels

• Infants with severe anemia

• Infants who are not on full feeds

• Infant with in-utero exposure to cocaine

Related Conditions & MeSH terms

• Neurodevelopmental Outcome
• Premature Birth

Intervention

Dietary Supplement:
• iron
High, intermediate and low iron dosage orally for 2 months

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean interpeak latency Auditory Neural Myelination	This will be measured using auditory brain stem response.	43-45 weeks PMA
Primary	mean visual neural myelination	Visual myelination will be evaluated by visual evoked response.	43-45 weeks PMA
Secondary	number of participants with executed function	Using a standardize test.	3-5 years