NCT00684697

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

6.7 years

First QC Date

May 22, 2008

Last Update Submit

March 1, 2021

Conditions

Neurodevelopmental Outcome

Keywords

premature infants iron neurodevelopment

Outcome Measures

Primary Outcomes (2)

  • mean interpeak latency Auditory Neural Myelination

    This will be measured using auditory brain stem response.

    43-45 weeks PMA

  • mean visual neural myelination

    Visual myelination will be evaluated by visual evoked response.

    43-45 weeks PMA

Secondary Outcomes (1)

  • number of participants with executed function

    3-5 years

Study Arms (3)

1

PLACEBO COMPARATOR

low iron dose

Dietary Supplement: iron

2

ACTIVE COMPARATOR

intermediate iron dose

Dietary Supplement: iron

3

EXPERIMENTAL

High Iron dose

Dietary Supplement: iron

Interventions

ironDIETARY_SUPPLEMENT

High, intermediate and low iron dosage orally for 2 months

123

Eligibility Criteria

AgeUp to 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Babies less than or equal to 33 weeks gestational age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Iron

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Sanjiv B Amin, MD MS

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 28, 2008

Study Start

May 1, 2009

Primary Completion

December 31, 2015

Study Completion

December 31, 2020

Last Updated

March 2, 2021

Record last verified: 2021-03

Locations

US(1)