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Completed

NCT Number: NCT01125163

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)?

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Memorial Hermann Hospital, Texas Medical Center

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Iron Supplement

Dietary 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

Multivitamin

Dietary Supplement

daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age

Other names: Multivitamin without iron

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

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 Infants

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 18, 2010
Registry last updated
Jan 4, 2019

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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