NCT00458068

Brief Summary

Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency. Hypothesis: Preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended. Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron supplementation may reduce the incidence of iron deficiency and the need for late blood transfusions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 1996

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1999

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
Last Updated

April 9, 2007

Status Verified

April 1, 2007

First QC Date

April 6, 2007

Last Update Submit

April 6, 2007

Conditions

Iron DeficiencyAnemia of Prematurity

Keywords

preterm infantiron supplementationiron deficiencyblood transfusion

Outcome Measures

Primary Outcomes (2)

  • Ferritin at 61 days of life

  • The number of infants who fulfilled the criteria of ID at any time throughout the study.

Secondary Outcomes (7)

  • Transferrin-Saturation

  • Hematocrit at day 61

  • Reticulocyte count at day 61

  • Mean corpuscular volume at day 61

  • Mean corpuscular hemoglobin at day 61

  • +2 more secondary outcomes

Interventions

Oral administration of ferrous sulphateDRUG

Eligibility Criteria

Age3 Days - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn infant
  • Birth weight of \<1301 g
  • Admitted between June 1996 and June 1999

You may not qualify if:

  • Major anomalies
  • Hemolytic disease
  • Twin-to-twin transfusion syndrome
  • Missing parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Ulm, 89070, Germany

Location

Related Publications (1)

  • Franz AR, Mihatsch WA, Sander S, Kron M, Pohlandt F. Prospective randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams. Pediatrics. 2000 Oct;106(4):700-6. doi: 10.1542/peds.106.4.700.

    PMID: 11015511RESULT

MeSH Terms

Conditions

Iron DeficienciesAnemiaPremature Birth

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Axel R Franz, MD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2007

First Posted

April 9, 2007

Study Start

June 1, 1996

Study Completion

September 1, 1999

Last Updated

April 9, 2007

Record last verified: 2007-04

Locations

DE(1)