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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Thrasher Research Fund
• Treatments: Arginine Vasopressin; Dopamine; Dopamine Agents; Vasopressins

Criteria

Inclusion Criteria:

• Infants less than 24 hours of age

• Infants with birth weight of <1001 grams and/or gestational age of <29 weeks

• Not initiated on any continuous pressor therapy prior to enrollment

• Intravenous line in place

• Outborn infants meeting eligibility criteria

Exclusion Criteria:

• Infants not meeting eligibility criteria

• Infants with life-threatening congenital defects

• Infants with congenital hydrops

• Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)

• Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).