Clinical trial NCT04525495: Dopamine in Neonate
Official title: Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neonates and Preterm Infants
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Severance Hospital
First posted: 2020-08-25
Enrollment: 30
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of dopamine which is used as treatment of hypotension in neonate and preterm infant.


Eligibility criteria: Inclusion Criteria:

* Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital
* Infants who were diagnosed with hypotension

Exclusion Criteria:

* Congenital heart disease
* Chromosomal anomaly
* Treated with ECMO or CRRT
* Arrhythmia
* Hypovolemic state

Primary outcomes:
measure: Steady state concentration of dopamine (Css) at 2mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
measure: Steady state concentration of dopamine (Css) at 5mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
measure: Steady state concentration of dopamine (Css) at 10mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
measure: Steady state concentration of dopamine (Css) at 15mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
measure: Steady state concentration of dopamine (Css) at 20mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Secondary outcomes:
measure: Blood pressure in mmHg at 2mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
measure: Blood pressure in mmHg at 5mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
measure: Blood pressure in mmHg at 10mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
measure: Blood pressure in mmHg at 10mcg/kg/min
timeFrame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
measure: Heart rate
timeFrame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
measure: Heart rate
timeFrame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
measure: Heart rate
timeFrame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
measure: Heart rate
timeFrame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
measure: Heart rate
timeFrame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
measure: Ejection fraction from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
measure: Ejection fraction from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
measure: Ejection fraction from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
measure: Ejection fraction from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
measure: Ejection fraction from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
measure: Fractional shortening from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
measure: Fractional shortening from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
measure: Fractional shortening from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
measure: Fractional shortening from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
measure: Fractional shortening from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
measure: Tei index from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
measure: Tei index from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
measure: Tei index from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
measure: Tei index from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
measure: Tei index from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
measure: VTI (velocity time integral) from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
measure: VTI (velocity time integral) from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
measure: VTI (velocity time integral) from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
measure: VTI (velocity time integral) from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
measure: VTI (velocity time integral) from Echocardiography
timeFrame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Children's Hospital
name: Han-Suk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: