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

What Was Tested

This registered not phased trial tested Vasopressin for low blood pressure and orthostatic hypotension.

Low blood pressure or hypotension is a very important problem that is often seen in premature babies, especially those with low birth weight.

An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent.

It had three arms (groups): Dopamine treatment (active comparator), Vasopressin treatment (active comparator) and Comparison Arm (no intervention).

Infants who did not require vasopressor support for hypotension during the first 24 hours of life.

The registry classes the interventions as drug.

More on the Plan

Hypotension in the low birth weight (LBW) and extremely low birth weight (ELBW) infant is often encountered in the postnatal adaptation phase.

The true definition of hypotension remains to be a question.

Effects on other organ systems can result in renal injury, hepatic injury, and the development of necrotizing enterocolitis among other complications.

Few studies compare dopamine to other agents as a first -line treatment.

Who Took Part

The registry lists 70 actual participants took part.

It was open to people of any sex aged up to 24 Hours.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: infants not meeting eligibility criteria; infants with life-threatening congenital defects; infants with congenital hydrops.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The low blood pressure and orthostatic hypotension participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

The Vasopressin group and the comparison group ran side by side rather than switching.

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-03 with completion listed for 2013-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life (time frame: 24 hours of life).

It also tracked 12 secondary outcomes, for example Heart Rate Change From Baseline, Acid-base Status, Hyponatremia, Urine Output, Evidence of Ischemic Changes and Necrotizing Enterocolitis.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 70 people with low blood pressure and orthostatic hypotension.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Vasopressin compound page, Low blood pressure and orthostatic hypotension research.