Trial Outcomes & Findings for Transfusions and Nitric Oxide Level in Preterm Infants (NCT NCT00787124)

Results Overview

levels were never run by the laboratory

Recruitment status

COMPLETED

Target enrollment

8 participants

Primary outcome timeframe

beginning and end of study

Results posted on

2018-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	<30 Days \< 28 weeks gestation, \< 30 days of age, \< 3 previous transfusions	>=30 \< 28 weeks gestation, \>=30 days of age, \>= 3 previous transfusions
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transfusions and Nitric Oxide Level in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	<30 Days n=4 Participants \< 28 weeks gestation, \< 30 days of age, \< 3 previous transfusions	>=30 n=4 Participants \< 28 weeks gestation, \>=30 days of age, \>= 3 previous transfusions	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	20 days STANDARD_DEVIATION 45 • n=5 Participants	60 days STANDARD_DEVIATION 37 • n=7 Participants	40 days STANDARD_DEVIATION 40 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: beginning and end of study

levels were never run by the laboratory

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: prior to, during, after transfusion

data not appropriately collected for the analysis due to machine malfunctions.

Outcome measures

Outcome data not reported

Adverse Events

<30 Days

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

>=30

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Smith

Duke University Medical Center

Phone: 9196688951

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place