N/A
N=70
Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT01318278 ↗Enrolled (actual)
70
Serious AEs
52.9%
Results posted
Mar 2015
Primary outcome: Primary: Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life — 9; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dopamine (Drug); Arginine Vasopressin (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life |
9; 9 | — |
| SECONDARY Heart Rate Change From Baseline |
31; 0 | — |
| SECONDARY Acid-base Status |
7.18; 7.2; 7.25 | — |
| SECONDARY Hyponatremia |
3; 3; 11 | — |
| SECONDARY Urine Output |
4.4; 3.5; 3.9 | — |
| SECONDARY Evidence of Ischemic Changes |
0; 0; 0 | — |
| SECONDARY Necrotizing Enterocolitis |
0; 1; 2 | — |
| SECONDARY Ventilator Days |
52; 45.5; 17.5 | — |
| SECONDARY Presence of Patent Ductus Arteriosus (PDA) |
5; 6; 34 | — |
| SECONDARY Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound |
3; 3; 6 | — |
| SECONDARY Retinopathy of Prematurity Stage 3 or Higher |
3; 2; 4 | — |
| SECONDARY Presence of Bronchopulmonary Dysplasia (BPD) |
8; 4; 31 | — |
| SECONDARY All Cause Mortality |
2; 4; 10 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01318278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.