Dopamine in Neonate

Neonates and Preterm Infants Clinical Trial

Official title:

Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04525495
• Other study ID #: DPMSNUH
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Neonates and Preterm Infants
• Premature Birth

Intervention

Drug:
• Dopamine
Dopamine treatment

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart rate		After continuous infusion for more than 30 minutes at 2mcg/kg/min
Secondary	Heart rate		After continuous infusion for more than 30 minutes at 5mcg/kg/min
Secondary	Heart rate		After continuous infusion for more than 30 minutes at 10mcg/kg/min
Secondary	Heart rate		After continuous infusion for more than 30 minutes at 15mcg/kg/min
Secondary	Heart rate		After continuous infusion for more than 30 minutes at 20mcg/kg/min
Secondary	Ejection fraction from Echocardiography		After continuous infusion for more than 30 minutes at 2mcg/kg/min
Secondary	Ejection fraction from Echocardiography		After continuous infusion for more than 30 minutes at 5mcg/kg/min
Secondary	Ejection fraction from Echocardiography		After continuous infusion for more than 30 minutes at 10mcg/kg/min
Secondary	Ejection fraction from Echocardiography		After continuous infusion for more than 30 minutes at 15mcg/kg/min
Secondary	Ejection fraction from Echocardiography		After continuous infusion for more than 30 minutes at 20mcg/kg/min
Secondary	Fractional shortening from Echocardiography		After continuous infusion for more than 30 minutes at 2mcg/kg/min
Secondary	Fractional shortening from Echocardiography		After continuous infusion for more than 30 minutes at 5mcg/kg/min
Secondary	Fractional shortening from Echocardiography		After continuous infusion for more than 30 minutes at 10mcg/kg/min
Secondary	Fractional shortening from Echocardiography		After continuous infusion for more than 30 minutes at 15mcg/kg/min
Secondary	Fractional shortening from Echocardiography		After continuous infusion for more than 30 minutes at 20mcg/kg/min
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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