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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224236
• Other study ID #: RCT of Iron Supplementation
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 14, 2010
• Last updated: June 17, 2015
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

Inclusion Criteria:

1. birth weight: < 1500 grams

2. Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age

3. =32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

1. cyanotic heart disease

2. bowel resection prior to enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Birth Weight

Intervention

Drug:
• Iron Supplement
2 mg/kg/day elemental iron as multivitamin with iron solution
• control
multivitamin solution without iron

Locations

Country	Name	City	State
United States	Children's Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit (Hct)	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.	36 weeks postmenstrual age (PMA)	Yes
Secondary	Transfusions	# of transfusions infants required after enrollment.	enrollment to 36 weeks postmenstrual age (PMA)	Yes