Iron Status and Myelination in Premature Infants (Piron)

University of Rochester

Status: Completed

Conditions: Neurodevelopmental Outcome

Treatments: Dietary Supplement: iron

Study type: Interventional

Funder types: Other

Identifiers

NCT00684697

Piron Trial

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

low iron dose

Treatment:

Dietary Supplement: iron

2

Active Comparator group

Description:

intermediate iron dose

Treatment:

Dietary Supplement: iron

3

Experimental group

Description:

High Iron dose

Treatment:

Dietary Supplement: iron