Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/22/2019 |
| Start Date: | March 2011 |
| End Date: | September 2013 |
Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study
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.
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.
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.
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.
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).
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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