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OpenTrials
Completed

NCT Number: NCT00684697

Iron Status and Myelination 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.

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Key information

Conditions

Neurodevelopmental Outcome

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron

Dietary Supplement

High, intermediate and low iron dosage orally for 2 months

Primary outcomes

  1. mean interpeak latency Auditory Neural Myelination

    Time frame: 43-45 weeks PMA

    This will be measured using auditory brain stem response.

  2. mean visual neural myelination

    Time frame: 43-45 weeks PMA

    Visual myelination will be evaluated by visual evoked response.

Secondary outcomes

  1. number of participants with executed function

    Time frame: 3-5 years

    Using a standardize test.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: Piron

Important dates

Study start
2009
Primary completion
2015
Study completion
2020
First posted
May 28, 2008
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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