Dopamine in Neonate

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants

Conditions
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Neonates and Preterm Infants

Intervention / Treatment
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* Drug: Dopamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dopamine treatment<br> | Drug: Dopamine<br>* Dopamine treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state concentration of dopamine (Css) at 2mcg/kg/min | dopamine drug level in blood | After continuous infusion for more than 30 minutes at 2mcg/kg/min | 
| Steady state concentration of dopamine (Css) at 5mcg/kg/min | dopamine drug level in blood | After continuous infusion for more than 30 minutes at 5mcg/kg/min | 
| Steady state concentration of dopamine (Css) at 10mcg/kg/min | dopamine drug level in blood | After continuous infusion for more than 30 minutes at 10mcg/kg/min | 
| Steady state concentration of dopamine (Css) at 15mcg/kg/min | dopamine drug level in blood | After continuous infusion for more than 30 minutes at 15mcg/kg/min | 
| Steady state concentration of dopamine (Css) at 20mcg/kg/min | dopamine drug level in blood | After continuous infusion for more than 30 minutes at 20mcg/kg/min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure in mmHg at 2mcg/kg/min | Systolic, diastolic and mean blood pressure in mmHg | After continuous infusion for more than 30 minutes at 2mcg/kg/min | 
| Blood pressure in mmHg at 5mcg/kg/min | Systolic, diastolic and mean blood pressure in mmHg | After continuous infusion for more than 30 minutes at 5mcg/kg/min | 
| Blood pressure in mmHg at 10mcg/kg/min | Systolic, diastolic and mean blood pressure in mmHg | After continuous infusion for more than 30 minutes at 10mcg/kg/min | 
| Blood pressure in mmHg at 10mcg/kg/min | Systolic, diastolic and mean blood pressure in mmHg | After continuous infusion for more than 30 minutes at 20mcg/kg/min | 
| Heart rate |  | After continuous infusion for more than 30 minutes at 2mcg/kg/min | 
| Heart rate |  | After continuous infusion for more than 30 minutes at 5mcg/kg/min | 
| Heart rate |  | After continuous infusion for more than 30 minutes at 10mcg/kg/min | 
| Heart rate |  | After continuous infusion for more than 30 minutes at 15mcg/kg/min | 
| Heart rate |  | After continuous infusion for more than 30 minutes at 20mcg/kg/min | 
| Ejection fraction from Echocardiography |  | After continuous infusion for more than 30 minutes at 2mcg/kg/min | 
| Ejection fraction from Echocardiography |  | After continuous infusion for more than 30 minutes at 5mcg/kg/min | 
| Ejection fraction from Echocardiography |  | After continuous infusion for more than 30 minutes at 10mcg/kg/min | 
| Ejection fraction from Echocardiography |  | After continuous infusion for more than 30 minutes at 15mcg/kg/min | 
| Ejection fraction from Echocardiography |  | After continuous infusion for more than 30 minutes at 20mcg/kg/min | 
| Fractional shortening from Echocardiography |  | After continuous infusion for more than 30 minutes at 2mcg/kg/min | 
| Fractional shortening from Echocardiography |  | After continuous infusion for more than 30 minutes at 5mcg/kg/min | 
| Fractional shortening from Echocardiography |  | After continuous infusion for more than 30 minutes at 10mcg/kg/min | 
| Fractional shortening from Echocardiography |  | After continuous infusion for more than 30 minutes at 15mcg/kg/min | 
| Fractional shortening from Echocardiography |  | After continuous infusion for more than 30 minutes at 20mcg/kg/min | 
| Tei index from Echocardiography | (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms) | After continuous infusion for more than 30 minutes at 2mcg/kg/min | 
| Tei index from Echocardiography | (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms) | After continuous infusion for more than 30 minutes at 5mcg/kg/min | 
| Tei index from Echocardiography | (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms) | After continuous infusion for more than 30 minutes at 10mcg/kg/min | 
| Tei index from Echocardiography | (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms) | After continuous infusion for more than 30 minutes at 15mcg/kg/min | 
| Tei index from Echocardiography | (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms) | After continuous infusion for more than 30 minutes at 20mcg/kg/min | 
| VTI (velocity time integral) from Echocardiography | the area within the spectral curve and indicates how far blood travels during the flow period | After continuous infusion for more than 30 minutes at 2mcg/kg/min | 
| VTI (velocity time integral) from Echocardiography | the area within the spectral curve and indicates how far blood travels during the flow period | After continuous infusion for more than 30 minutes at 5mcg/kg/min | 
| VTI (velocity time integral) from Echocardiography | the area within the spectral curve and indicates how far blood travels during the flow period | After continuous infusion for more than 30 minutes at 10mcg/kg/min | 
| VTI (velocity time integral) from Echocardiography | the area within the spectral curve and indicates how far blood travels during the flow period | After continuous infusion for more than 30 minutes at 15mcg/kg/min | 
| VTI (velocity time integral) from Echocardiography | the area within the spectral curve and indicates how far blood travels during the flow period | After continuous infusion for more than 30 minutes at 20mcg/kg/min |