Dopamine in Neonate

Phase 2

• Conditions: Neonates and Preterm Infants
• Interventions: Drug: Dopamine

• Registration Number: NCT04525495
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dopamine treatment	Dopamine	-

Primary Outcome Measures

Name	Time	Method
Steady state concentration of dopamine (Css) at 2mcg/kg/min	After continuous infusion for more than 30 minutes at 2mcg/kg/min	dopamine drug level in blood
Steady state concentration of dopamine (Css) at 20mcg/kg/min	After continuous infusion for more than 30 minutes at 20mcg/kg/min	dopamine drug level in blood
Steady state concentration of dopamine (Css) at 5mcg/kg/min	After continuous infusion for more than 30 minutes at 5mcg/kg/min	dopamine drug level in blood
Steady state concentration of dopamine (Css) at 10mcg/kg/min	After continuous infusion for more than 30 minutes at 10mcg/kg/min	dopamine drug level in blood
Steady state concentration of dopamine (Css) at 15mcg/kg/min	After continuous infusion for more than 30 minutes at 15mcg/kg/min	dopamine drug level in blood

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of