Trial · NCT02527798

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)

NCT02527798, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2021-12-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD). Trials, record NCT02527798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02527798

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
NCT number: NCT02527798
Status: Completed
Phases: Phase 2
Enrollment: 82 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Bronchopulmonary Dysplasia
Interventions: Furosemide Cohort 1, Furosemide Cohort 2, Furosemide Cohort 3, Placebo
First posted: 2015-08-19
Last updated: 2021-12-28
Results first posted: 2021-12-28

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety as Determined by Adverse Events	35 days for each participant	Safety was assessed following the initial study-specific procedure (e.g., screening blood draws, dosing) through 7 days post last study dose by frequency and incidence of adverse events and serious adverse events.
Secondary	Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Risk measured weekly through Week 4	Moderate-severe BPD or death risk was defined by the NICHD Neonatal Research Network (NRN) BPD outcome estimator which provides an estimate of the risk of BPD (none, mild, moderate, severe) or death by postnatal day and is presented as a percentage. For this protocol, the categories were dichotomized to none-mild vs. moderate-severe-death. The risk of BPD or death was defined by the NICHD NRN BPD estimator on days 7, 14, 21 and 28 of study drug using the closest day available from the BPD estimator. The BPD estimator includes infants up to 28 postnatal days; for infants in this protocol older than that, 28-day estimates are used.
Secondary	Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined	36 weeks postmenstrual age	Moderate-severe BPD or death risk was defined using the NICHD Neonatal Research Network BPD outcome estimator.
Secondary	Clearance	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.
Secondary	Volume of Distribution	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.
Secondary	Half-life	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.
Secondary	Area Under the Plasma Concentration Versus Time Curve	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Population PK data were collected from the two Furosemide cohorts and includes all 39 active drug recipients.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety as Determined by Adverse Events	35 days for each participant	Based on Cohort 2 safety data analysis, enrollment was stopped prior to Cohort 3. Data are reported for the safety population.	Events	NUMBER
SECONDARY	Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Risk measured weekly through Week 4	Data are reported for the safety population. Overall 82 participants were randomized, but 2 were not dosed. 80 participants were analyzed for BPD status.~Based on Cohort 2 safety data analysis, enrollment was stopped prior to Cohort 3.	percent probability of BPD or death risk	MEAN
SECONDARY	Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined	36 weeks postmenstrual age	Data are reported for the safety population. Based on Cohort 2 safety data analysis, enrollment was stopped prior to Cohort 3.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clearance	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Data was collected from the Furosemide cohort 1 and 2, and combined. In total 39 active drug recipients participated in the population PK.	(mL/h/kg)	MEDIAN
SECONDARY	Volume of Distribution	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Data was collected from the Furosemide Cohort 1 and Cohort 2 and combined. In total, 39 active drug recipients participated in the population PK.	mL	MEDIAN
SECONDARY	Half-life	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Data were collected from the two Furosemide cohorts and the combined analysis includes all 39 active drug recipients who participated in the population PK .	hours	MEDIAN
SECONDARY	Area Under the Plasma Concentration Versus Time Curve	After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.	Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.	mg*h/L	MEDIAN

Source ClinicalTrials.gov

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Safety as Determined by Adverse Events	Furosemide Cohort 1		123		Events
Safety as Determined by Adverse Events	Placebo Cohort 1		29		Events
Safety as Determined by Adverse Events	Furosemide Cohort 2		100		Events
Safety as Determined by Adverse Events	Placebo Cohort 2		49		Events
Safety as Determined by Adverse Events	Total		293		Events
Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Furosemide Cohort 1	Week 0	57.9	Standard Deviation 20.5	percent probability of BPD or death risk
Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Placebo Cohort 1	Week 0	52.8	Standard Deviation 23.0	percent probability of BPD or death risk
Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Furosemide Cohort 2	Week 0	66.7	Standard Deviation 16.8	percent probability of BPD or death risk
Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Placebo Cohort 2	Week 0	70.9	Standard Deviation 22.2	percent probability of BPD or death risk
Moderate-Severe BPD or Death Risk Throughout Weekly Treatment	Weekly Total	Week 0	62.3	Standard Deviation 20.2	percent probability of BPD or death risk

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Furosemide Cohort 1	32
Overall Study	STARTED	Placebo Cohort 1	10
Overall Study	STARTED	Furosemide Cohort 2	30
Overall Study	STARTED	Placebo Cohort 2	10
Overall Study	STARTED	Furosemide Cohort 3	0
Overall Study	STARTED	Placebo Cohort 3	0
Overall Study	Randomized, Not Dosed	Furosemide Cohort 1	31
Overall Study	Randomized, Not Dosed	Placebo Cohort 1	9
Overall Study	Randomized, Not Dosed	Furosemide Cohort 2	30
Overall Study	Randomized, Not Dosed	Placebo Cohort 2	10

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events462

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Petechiae	Skin and subcutaneous tissue disorders	Furosemide Cohort 1	0	31	0
other	Petechiae	Skin and subcutaneous tissue disorders	Placebo Cohort 1	0	9	0
other	Petechiae	Skin and subcutaneous tissue disorders	Furosemide Cohort 2	0	30	0
other	Petechiae	Skin and subcutaneous tissue disorders	Placebo Cohort 2	1	10	1
other	Petechiae	Skin and subcutaneous tissue disorders	Furosemide Cohort 3	0	0
other	Petechiae	Skin and subcutaneous tissue disorders	Placebo Cohort 3	0	0
other	Chronic Respiratory Disease	Respiratory, thoracic and mediastinal disorders	Furosemide Cohort 1	5	31	5
other	Chronic Respiratory Disease	Respiratory, thoracic and mediastinal disorders	Placebo Cohort 1	0	9	0
other	Chronic Respiratory Disease	Respiratory, thoracic and mediastinal disorders	Furosemide Cohort 2	0	30	0
other	Chronic Respiratory Disease	Respiratory, thoracic and mediastinal disorders	Placebo Cohort 2	0	10	0

1 to 10 of 462Source ClinicalTrials.gov

See all 462 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Furosemide Cohort 1	0	31
Total, all-cause mortality	Placebo Cohort 1	0	9
Total, all-cause mortality	Furosemide Cohort 2	1	30
Total, all-cause mortality	Placebo Cohort 2	0	10
Total, all-cause mortality	Furosemide Cohort 3	0	0
Total, all-cause mortality	Placebo Cohort 3	0	0
Total, other adverse events	Furosemide Cohort 1	28	31
Total, other adverse events	Placebo Cohort 1	9	9
Total, other adverse events	Furosemide Cohort 2	28	30
Total, other adverse events	Placebo Cohort 2	9	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40306549	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01FD005101	Safety of furosemide in premature infants at risk of bronchopulmonary dysplasia	LAUGHON, MATTHEW	UNIV OF NORTH CAROLINA CHAPEL HILL	FOOD AND DRUG ADMINISTRATION	2016 to 2018

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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