Neurodevelopmental OutcomePironNCT00684697
Iron Status and Myelination in Premature Infants
A study testing iron in people with Neurodevelopmental Outcome, run by University of Rochester at 1 site in United States.
Trial summary
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Neurodevelopmental Outcome
- What is being tested?
- iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies less than or equal to 33 weeks gestational age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.
- Conditions
- Neurodevelopmental Outcome
- Being tested
- iron
- Keywords
- premature infants iron neurodevelopment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ironDietary supplement
High, intermediate and low iron dosage orally for 2 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | low iron dose Receives: Dietary Supplement: iron |
| 2 | Active comparator | intermediate iron dose Receives: Dietary Supplement: iron |
| 3 | Experimental | High Iron dose Receives: Dietary Supplement: iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean interpeak latency Auditory Neural Myelination
This will be measured using auditory brain stem response.
Measured: 43-45 weeks PMA
mean visual neural myelination
Visual myelination will be evaluated by visual evoked response.
Measured: 43-45 weeks PMA
Secondary outcomes (1)
number of participants with executed function
Using a standardize test.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startMay 2009
- Primary completion31 Dec 2015
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental OutcomeStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjiv B Amin, MD MS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684697
- Sponsor's protocol ID
- Piron Trial
- Acronym
- Piron
- Status last verified
- Mar 2021
- First submitted
- 22 May 2008
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants
- ClinicalTrials.gov ID
- NCT00684697
- Acronym / sponsor ID
- Piron / Piron Trial
- Conditions
- Neurodevelopmental Outcome
- Keywords
- premature infants iron neurodevelopment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: ironlow iron dose |
| 2 | Active comparator | Dietary Supplement: ironintermediate iron dose |
| 3 | Experimental | Dietary Supplement: ironHigh Iron dose |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Babies less than or equal to 33 weeks gestational age
Key exclusion criteria (8 listed)
- Infants with cranio-facial malformations
- Torch infections
- Infants with hearing disorders
- Infants receiving erythropoietin
- Infants with subnormal vitamin E levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ironHigh, intermediate and low iron dosage orally for 2 months | Dietary supplement | 1, 2, 3 |
Primary outcome
mean interpeak latency Auditory Neural Myelination
Time frame: 43-45 weeks PMA
This will be measured using auditory brain stem response.
mean visual neural myelination
Time frame: 43-45 weeks PMA
Visual myelination will be evaluated by visual evoked response.
1 secondary outcome
number of participants with executed function
Time frame: 3-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjiv B Amin, MD MS principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iron in people with Neurodevelopmental Outcome, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean interpeak latency Auditory Neural Myelination (time frame: 43-45 weeks PMA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.