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Completed

NCT Number: NCT01224236

Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants

The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

Up to 8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA).

All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth.

VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • birth weight: < 1500 grams
  • Tolerating iron fortified preterm formula or fortified breast 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

Treatment and study plan

Iron Supplement

Drug

2 mg/kg/day elemental iron as multivitamin with iron solution

Control

Drug

multivitamin solution without iron

Primary outcomes

  1. Hematocrit (Hct)

    Time frame: 36 weeks postmenstrual age (PMA)

    For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.

Secondary outcomes

  1. Transfusions

    Time frame: enrollment to 36 weeks postmenstrual age (PMA)

    # of transfusions infants required after enrollment.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2010
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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