Clinical trial NCT01318278: Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
Official title: Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Keywords: Hypotension
Low blood pressure
Neonate
Dopamine
Vasopressin
Extremely Low Birth Weight Infant
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2011-03-18
Enrollment: 70
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Hypotension in the low birth weight (LBW) and extremely low birth weight (ELBW) infant is often encountered in the postnatal adaptation phase. Severe, prolonged hypotension contributes to cellular dysfunction and cell death. Systemic hypotension affects close to half of all ELBW infants and a significant portion of LBW infants. The true definition of hypotension remains to be a question. There is a linear association between birth weight, gestational age, and mean blood pressure but blood pressure can vary significantly in the first day of life. The critical period tends to be the first 24-36 hours of life as blood pressure tends to rise significantly in the first 72 hours of life regardless of gestational age. Preterm infants suffering from hypotension have a higher incidence and increased severity of intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and long-term neurodevelopmental sequelae compared to normotensive preterm infants. Effects on other organ systems can result in renal injury, hepatic injury, and the development of necrotizing enterocolitis among other complications. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Dopamine is commonly used as first-line therapy, but issues with efficacy and its side effect profile have lessened its favorability over the years. Few studies compare dopamine to other agents as a first -line treatment. This study hopes to contribute to the literature information on vasopressin as a potential first-line agent for treatment of neonatal hypotension in low birth weight infants.

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).

Primary outcomes:
measure: Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life
timeFrame: 24 hours of life
Secondary outcomes:
measure: Heart Rate Change From Baseline
timeFrame: 96 hours or until hypotension completely resolved and medications stopped
measure: Acid-base Status
timeFrame: 96 hours or until hypotension resolved and medication completely stopped
measure: Hyponatremia
timeFrame: 96 hours or until medication completely stopped
measure: Urine Output
timeFrame: 96 hours or until hypotension resolved and medication completely stopped
measure: Evidence of Ischemic Changes
timeFrame: 96 hours or until medication completely stopped
measure: Necrotizing Enterocolitis
timeFrame: until hospital discharge, up to 12 weeks
measure: Ventilator Days
timeFrame: Until hospital discharge, up to 15 months
measure: Presence of Patent Ductus Arteriosus (PDA)
timeFrame: until hospital discharge, up to 12 weeks
measure: Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound
timeFrame: Until hospital discharge, up to 15 months
measure: Retinopathy of Prematurity Stage 3 or Higher
timeFrame: Until hospital discharge, up to 15 months
measure: Presence of Bronchopulmonary Dysplasia (BPD)
timeFrame: 36 weeks postmenstrual age
measure: All Cause Mortality
timeFrame: admission to hospital discharge, up to 15 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Danielle R Rios, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rios DR, Kaiser JR. Vasopressin versus dopamine for treatment of hypotension in extremely low birth weight infants: a randomized, blinded pilot study. J Pediatr. 2015 Apr;166(4):850-5. doi: 10.1016/j.jpeds.2014.12.027. Epub 2015 Jan 29.