Trial Outcomes & Findings for Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants (NCT NCT01125163)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

at 36 weeks adjusted postmenstrual age

Results posted on

2019-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Multivitamin With Iron daily oral multivitamin providing 2mg/kg of iron	Multivitamin Without Iron daily oral multivitamin without iron
Overall Study STARTED	76	74
Overall Study COMPLETED	76	74
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multivitamin With Iron n=76 Participants daily oral multivitamin providing 2mg/kg of iron	Multivitamin Without Iron n=74 Participants daily oral multivitamin without iron	Total n=150 Participants Total of all reporting groups
Age, Continuous	27.3 gestational age (weeks) STANDARD_DEVIATION 2.0 • n=99 Participants	27.3 gestational age (weeks) STANDARD_DEVIATION 2.1 • n=107 Participants	27.3 gestational age (weeks) STANDARD_DEVIATION 2 • n=206 Participants
Sex: Female, Male Female	38 Participants n=99 Participants	35 Participants n=107 Participants	73 Participants n=206 Participants
Sex: Female, Male Male	38 Participants n=99 Participants	39 Participants n=107 Participants	77 Participants n=206 Participants
Region of Enrollment United States	76 participants n=99 Participants	74 participants n=107 Participants	150 participants n=206 Participants

PRIMARY outcome

Timeframe: at 36 weeks adjusted postmenstrual age

Population: Sample size was based on a retrospective observational pilot study from the 2008 calendar year. A sample size of 75 per group was chosen to achieve 80% power to detect a difference in Hct of 2 % between groups, assuming a mean Hct of 25.6% in the control group, a standard deviation 4.4%, with alpha level (0.05) using a two-sided two-sample t-test.

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.

Outcome measures

Outcome measures
Measure	Multivitamin With Iron n=76 Participants daily oral multivitamin providing 2mg/kg/day of iron	Multivitamin Without Iron n=74 Participants daily oral multivitamin without iron
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)	29.2 % Hematocrit Standard Deviation 4.0	28.2 % Hematocrit Standard Deviation 4.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Multivitamin With Iron n=76 Participants daily oral multivitamin providing 2mg/kg/day of iron	Multivitamin Without Iron n=74 Participants daily oral multivitamin without iron
Number of Participants Who Received Red Cell Transfusions During Intervention Period	48 participants	54 participants

Adverse Events

Multivitamin With Iron

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Multivitamin Without Iron

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Multivitamin With Iron n=76 participants at risk daily oral multivitamin providing 2mg/kg of iron	Multivitamin Without Iron n=74 participants at risk daily oral multivitamin without iron
Gastrointestinal disorders Death	7.7% 1/13 • Number of events 1	11.1% 1/9 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kathleen A. Kennedy

UTexas_Houston

Phone: 713-500-6708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place