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

Phase 2

Completed

• Conditions: Anemia
• Interventions: Drug: Iron Supplement; Drug: control

• Registration Number: NCT01224236
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2013-07-03
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-17
• Last Update Submitted: 2015-06-17
• Results First Posted: 2015-06-19
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iron supplementation	Iron Supplement	2 mg/kg/day of elemental iron as a multivitamin with iron solution
control	control	multivitamin solution without iron

Primary Outcome Measures

Name	Time	Method
Hematocrit (Hct)	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 Outcome Measures

Name	Time	Method
Transfusions	enrollment to 36 weeks postmenstrual age (PMA)	# of transfusions infants required after enrollment.

Trial Locations

Locations (1)

Children's Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States