Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants

July 10, 2018 updated by: The University of Texas Health Science Center, Houston

Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants

In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Children's Memorial Hermann Hospital, Texas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Birth weight <1500 grams
  • Tolerating iron fortified preterm formula or fortified human milk at 120cc/kg/day by 8 weeks of age
  • </= 32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

  • Cyanotic heart disease
  • Bowel resection prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: multivitamin with iron
daily oral multivitamin providing 2mg/kg of iron
Dietary supplement: Iron Supplement
multivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120 ml/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted postmenstrual age.
Other Names:
  • iron supplementation
Placebo Comparator: multivitamin without iron
daily oral multivitamin without iron
Dietary supplement: multivitamin
daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age
Other Names:
  • Multivitamin without iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
Time Frame: at 36 weeks adjusted postmenstrual age
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome.
at 36 weeks adjusted postmenstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Received Red Cell Transfusions During Intervention Period
Time Frame: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner
The numbers below represent the number of participants in each arm that received a transfusion during intervention period.
from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Tiffany Taylor, M.D., The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 18, 2010

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-10-0031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe