Dopamine in Neonate

Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Neonates and Preterm Infants
• Intervention / Treatment: Drug: Dopamine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dopamine treatment	Drug: Dopamine; Dopamine treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; Severance Hospital
• Investigators: Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Sympathomimetics; Dopamine
• Other Study ID Numbers: DPMSNUH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No