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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125163
• Other study ID #: HSC-MS-10-0031
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: February 2012

Study information

• Verified date: July 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)?

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Birth Weight
• Iron Deficiency Anemia

Intervention

Dietary Supplement:
• Iron 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.
• multivitamin
daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age

Locations

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

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Who Received Red Cell Transfusions During Intervention Period	The numbers below represent the number of participants in each arm that received a transfusion during intervention period.	from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner