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

NCT01125163 | Completed Results

• 1 other identifier: HSC-MS-10-0031
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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)?

Conditions

Iron Deficiency Anemia

Keywords

very low birth weight infants; anemia; iron supplementation

Outcome Measures

Primary Outcomes (1)

• Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)

  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 Outcomes (1)

• Number of Participants Who Received Red Cell Transfusions During Intervention Period

  from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner

Study Arms (2)

multivitamin with iron

ACTIVE COMPARATOR

daily oral multivitamin providing 2mg/kg of iron

Dietary Supplement: Iron Supplement

multivitamin without iron

PLACEBO COMPARATOR

daily oral multivitamin without iron

Dietary Supplement: multivitamin

Interventions

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.

Also known as: iron supplementation

multivitamin with iron

multivitamin DIETARY_SUPPLEMENT

daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age

Also known as: Multivitamin without iron

multivitamin without iron

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Cyanotic heart disease
• Bowel resection prior to enrollment

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Children's Memorial Hermann Hospital, Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Taylor TA, Kennedy KA. Randomized trial of iron supplementation versus routine iron intake in VLBW infants. Pediatrics. 2013 Feb;131(2):e433-8. doi: 10.1542/peds.2012-1822. Epub 2013 Jan 21.

  PMID: 23339225 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

Iron-Dextran Complex; Geritol; Iron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Limitations and Caveats

This trial was done in a setting where relatively liberal transfusion guidelines (based on PINT study) are used so difficult to generalize to settings where restrictive transfusion guidelines are used.

Results Point of Contact

• Title: Dr. Kathleen A. Kennedy
• Organization: UTexas_Houston

Kathleen.A.Kennedy@uth.tmc.edu

713-500-6708

Study Officials

• Tiffany Taylor, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 18, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-07

Locations

US (1)