Trial Outcomes & Findings for Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants (NCT NCT01224236)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

150 participants

Primary outcome timeframe

36 weeks postmenstrual age (PMA)

Results posted on

2015-06-19

Participant Flow

Infants were screened by birth weight on admission to the neonatal intensive care unit (NICU). If birth weight criteria were met, infants were followed to see if they met eligibility criteria. If they approached eligibility, parents were approached for consent by the investigator. IRB approved to recruit 4/6/2010. Enrollment completed by 10/2012.

All groups started the study intervention once they had reached goal feedings of 120 cc/kg/day

Participant milestones

Participant milestones
Measure	Iron Supplementation 2 mg/kg/day of elemental iron as a multivitamin with iron solution	Control multivitamin solution without iron
Overall Study STARTED	76	74
Overall Study COMPLETED	75	73
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iron Supplementation n=76 Participants 2 mg/kg/day of elemental iron as a multivitamin with iron solution	Control n=74 Participants multivitamin solution without iron	Total n=150 Participants Total of all reporting groups
Age, Continuous	29.7 weeks STANDARD_DEVIATION 1.5 • n=5 Participants	29.7 weeks STANDARD_DEVIATION 1.4 • n=7 Participants	29.7 weeks STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants	74 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Iron Supplementation n=75 Participants 2 mg/kg/day of elemental iron as a multivitamin with iron solution	Control n=73 Participants multivitamin solution without iron
Hematocrit (Hct)	29.2 percentage of red blood cells in blood Standard Deviation 4	28.3 percentage of red blood cells in blood Standard Deviation 4.5

SECONDARY outcome

Timeframe: enrollment to 36 weeks postmenstrual age (PMA)

\# of transfusions infants required after enrollment.

Outcome measures

Outcome measures
Measure	Iron Supplementation n=76 Participants 2 mg/kg/day of elemental iron as a multivitamin with iron solution	Control n=74 Participants multivitamin solution without iron
Transfusions	1 transfusions Interval 0.0 to 2.0	1 transfusions Interval 0.0 to 2.0

Adverse Events

Iron Supplementation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Iron Supplementation n=76 participants at risk 2 mg/kg/day of elemental iron as a multivitamin with iron solution	Control n=74 participants at risk multivitamin solution without iron
Pregnancy, puerperium and perinatal conditions death	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Kennedy

University of Texas Health Science Center - Houston

Phone: +1 (713) 500-5651

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place