Neurodevelopmental Outcome Clinical Trial
— PironOfficial title:
Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants
NCT number | NCT00684697 |
Other study ID # | Piron Trial |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2009 |
Est. completion date | December 31, 2020 |
Verified date | March 2021 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
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 |
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