Iron Status and Myelination in Premature Infants

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00684697

Acronym

Piron

Enrollment

100

Registered

2008-05-28

Start date

2009-05-31

Completion date

2020-12-31

Last updated

2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental Outcome

Keywords

premature infants iron neurodevelopment

Brief summary

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

Interventions

DIETARY_SUPPLEMENTiron

High, intermediate and low iron dosage orally for 2 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 32 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
mean interpeak latency Auditory Neural Myelination	43-45 weeks PMA	This will be measured using auditory brain stem response.
mean visual neural myelination	43-45 weeks PMA	Visual myelination will be evaluated by visual evoked response.

Secondary

Measure	Time frame	Description
number of participants with executed function	3-5 years	Using a standardize test.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026