CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Dopamine +1 moredrug
Likely dose
Dopamine 20 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01318278
NCT01318278N/ACompleted

Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study

Baylor College of Medicine·interventional·Posted Mar 18, 2011·Updated Feb 20, 2019

In Brief

A clinical study evaluating Dopamine and Arginine Vasopressin for Hypotension. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Low blood pressure or hypotension is a very important problem that is often seen in premature babies, especially those with low birth weight. Severe hypotension leads to significant problems including brain bleeds, developmental delays, kidney and liver problems, and other issues that can affect babies for the rest of their lives. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Research is being conducted to try to find the best medication to use in these situations. Dopamine is often used first, but it does not always prove to be effective, and it has several concerning side effects. This study will look at vasopressin, which has fewer side effects, as a first-line medication for low blood pressure in extremely low birth weight infants. Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in preterm, extremely low birth weight infants who have hypotension within the first 24 hours of life. We will specifically look at its ability to raise blood pressure values, improve clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypotension
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2011
Enrollment StartMar 1, 2011
Primary CompletionJan 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.3 years ago

Interventions

Dopaminedrug

dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressindrug

vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy