Trial · NCT01318278

Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants

NCT01318278, Not applicable, Completed, Baylor College of Medicine; results first posted 2015-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants. Trials, record NCT01318278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01318278

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Trial

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

Title: Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
NCT number: NCT01318278
Status: Completed
Phases: Not applicable
Enrollment: 70 participants, actual
Lead sponsor: Baylor College of Medicine
Conditions: Hypotension
Interventions: Dopamine, Arginine Vasopressin
First posted: 2011-03-18
Last updated: 2019-02-20
Results first posted: 2015-03-10

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life	24 hours of life	Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP
Secondary	Heart Rate Change From Baseline	96 hours or until hypotension completely resolved and medications stopped	Heart rate change from baseline during study drug administration
Secondary	Acid-base Status	96 hours or until hypotension resolved and medication completely stopped
Secondary	Hyponatremia	96 hours or until medication completely stopped
Secondary	Urine Output	96 hours or until hypotension resolved and medication completely stopped
Secondary	Evidence of Ischemic Changes	96 hours or until medication completely stopped	Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.
Secondary	Necrotizing Enterocolitis	until hospital discharge, up to 12 weeks
Secondary	Ventilator Days	Until hospital discharge, up to 15 months
Secondary	Presence of Patent Ductus Arteriosus (PDA)	until hospital discharge, up to 12 weeks
Secondary	Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound	Until hospital discharge, up to 15 months

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life	24 hours of life	This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.	participants	NUMBER
SECONDARY	Heart Rate Change From Baseline	96 hours or until hypotension completely resolved and medications stopped	This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.	beats per minute	MEAN
SECONDARY	Acid-base Status	96 hours or until hypotension resolved and medication completely stopped	Treatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gases	pH	MEAN
SECONDARY	Hyponatremia	96 hours or until medication completely stopped		participants	NUMBER
SECONDARY	Urine Output	96 hours or until hypotension resolved and medication completely stopped		ml/kg/hr	MEAN
SECONDARY	Evidence of Ischemic Changes	96 hours or until medication completely stopped		participants	NUMBER
SECONDARY	Necrotizing Enterocolitis	until hospital discharge, up to 12 weeks		participants	NUMBER
SECONDARY	Ventilator Days	Until hospital discharge, up to 15 months		days	MEDIAN
SECONDARY	Presence of Patent Ductus Arteriosus (PDA)	until hospital discharge, up to 12 weeks		participants	NUMBER
SECONDARY	Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound	Until hospital discharge, up to 15 months		participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group37

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

Outcome	Group	Value	Spread	Units
Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life	Dopamine Treatment	9		participants
Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life	Vasopressin Treatment	9		participants
Heart Rate Change From Baseline	Dopamine Treatment	31	Standard Deviation 19	beats per minute
Heart Rate Change From Baseline	Vasopressin Treatment	0	Standard Deviation 10	beats per minute
Acid-base Status	Dopamine Treatment	7.18	Standard Deviation .07	pH
Acid-base Status	Vasopressin Treatment	7.2	Standard Deviation .07	pH
Acid-base Status	Comparison Group	7.25	Standard Deviation .09	pH
Hyponatremia	Dopamine Treatment	3		participants
Hyponatremia	Vasopressin Treatment	3		participants
Hyponatremia	Comparison Arm	11		participants

1 to 10 of 37Source ClinicalTrials.gov

See all 37 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dopamine Treatment	10
Overall Study	STARTED	Vasopressin Treatment	10
Overall Study	STARTED	Comparison Arm	50
Overall Study	COMPLETED	Dopamine Treatment	10
Overall Study	COMPLETED	Vasopressin Treatment	10
Overall Study	COMPLETED	Comparison Arm	50
Overall Study	NOT COMPLETED	Dopamine Treatment	0
Overall Study	NOT COMPLETED	Vasopressin Treatment	0
Overall Study	NOT COMPLETED	Comparison Arm	0

Source ClinicalTrials.gov

Adverse events12

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
other	Hyponatremia	Renal and urinary disorders	Dopamine Treatment	3	10
other	Hyponatremia	Renal and urinary disorders	Vasopressin Treatment	4	10
other	Hyponatremia	Renal and urinary disorders	Comparison Arm	11	50
serious	Necrotizing Enterocolitis	Gastrointestinal disorders	Dopamine Treatment	1	10
serious	Necrotizing Enterocolitis	Gastrointestinal disorders	Vasopressin Treatment	0	10
serious	Necrotizing Enterocolitis	Gastrointestinal disorders	Comparison Arm	7	50
serious	Bowel Perforation	Gastrointestinal disorders	Dopamine Treatment	3	10
serious	Bowel Perforation	Gastrointestinal disorders	Vasopressin Treatment	2	10
serious	Bowel Perforation	Gastrointestinal disorders	Comparison Arm	4	50
serious	Sepsis	Infections and infestations	Dopamine Treatment	4	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dopamine Treatment	2	10
Total, all-cause mortality	Vasopressin Treatment	4	10
Total, all-cause mortality	Comparison Arm	10	50
Total, other adverse events	Dopamine Treatment	3	10
Total, other adverse events	Vasopressin Treatment	4	10
Total, other adverse events	Comparison Arm	11	50
Total, serious adverse events	Dopamine Treatment	8	10
Total, serious adverse events	Vasopressin Treatment	7	10
Total, serious adverse events	Comparison Arm	22	50

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25641242	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Dopamine Treatment vs Vasopressin Treatment: Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life

Source Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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