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Dopamine in Neonate

Primary Purpose

Neonates and Preterm Infants

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dopamine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonates and Preterm Infants

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dopamine treatment

Arm Description

Outcomes

Primary Outcome Measures

Steady state concentration of dopamine (Css) at 2mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 5mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 10mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 15mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 20mcg/kg/min
dopamine drug level in blood

Secondary Outcome Measures

Blood pressure in mmHg at 2mcg/kg/min
Systolic, diastolic and mean blood pressure in mmHg
Blood pressure in mmHg at 5mcg/kg/min
Systolic, diastolic and mean blood pressure in mmHg
Blood pressure in mmHg at 10mcg/kg/min
Systolic, diastolic and mean blood pressure in mmHg
Blood pressure in mmHg at 10mcg/kg/min
Systolic, diastolic and mean blood pressure in mmHg
Heart rate
Heart rate
Heart rate
Heart rate
Heart rate
Ejection fraction from Echocardiography
Ejection fraction from Echocardiography
Ejection fraction from Echocardiography
Ejection fraction from Echocardiography
Ejection fraction from Echocardiography
Fractional shortening from Echocardiography
Fractional shortening from Echocardiography
Fractional shortening from Echocardiography
Fractional shortening from Echocardiography
Fractional shortening from Echocardiography
Tei index from Echocardiography
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Tei index from Echocardiography
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Tei index from Echocardiography
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Tei index from Echocardiography
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Tei index from Echocardiography
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
VTI (velocity time integral) from Echocardiography
the area within the spectral curve and indicates how far blood travels during the flow period
VTI (velocity time integral) from Echocardiography
the area within the spectral curve and indicates how far blood travels during the flow period
VTI (velocity time integral) from Echocardiography
the area within the spectral curve and indicates how far blood travels during the flow period
VTI (velocity time integral) from Echocardiography
the area within the spectral curve and indicates how far blood travels during the flow period
VTI (velocity time integral) from Echocardiography
the area within the spectral curve and indicates how far blood travels during the flow period

Full Information

First Posted
July 26, 2020
Last Updated
August 20, 2020
Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04525495
Brief Title
Dopamine in Neonate
Official Title
Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonates and Preterm Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dopamine treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dopamine
Intervention Description
Dopamine treatment
Primary Outcome Measure Information:
Title
Steady state concentration of dopamine (Css) at 2mcg/kg/min
Description
dopamine drug level in blood
Time Frame
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Title
Steady state concentration of dopamine (Css) at 5mcg/kg/min
Description
dopamine drug level in blood
Time Frame
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Title
Steady state concentration of dopamine (Css) at 10mcg/kg/min
Description
dopamine drug level in blood
Time Frame
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Title
Steady state concentration of dopamine (Css) at 15mcg/kg/min
Description
dopamine drug level in blood
Time Frame
After continuous infusion for more than 30 minutes at 15mcg/kg/min
Title
Steady state concentration of dopamine (Css) at 20mcg/kg/min
Description
dopamine drug level in blood
Time Frame
After continuous infusion for more than 30 minutes at 20mcg/kg/min
Secondary Outcome Measure Information:
Title
Blood pressure in mmHg at 2mcg/kg/min
Description
Systolic, diastolic and mean blood pressure in mmHg
Time Frame
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Title
Blood pressure in mmHg at 5mcg/kg/min
Description
Systolic, diastolic and mean blood pressure in mmHg
Time Frame
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Title
Blood pressure in mmHg at 10mcg/kg/min
Description
Systolic, diastolic and mean blood pressure in mmHg
Time Frame
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Title
Blood pressure in mmHg at 10mcg/kg/min
Description
Systolic, diastolic and mean blood pressure in mmHg
Time Frame
After continuous infusion for more than 30 minutes at 20mcg/kg/min
Title
Heart rate
Time Frame
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Title
Heart rate
Time Frame
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Title
Heart rate
Time Frame
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Title
Heart rate
Time Frame
After continuous infusion for more than 30 minutes at 15mcg/kg/min
Title
Heart rate
Time Frame
After continuous infusion for more than 30 minutes at 20mcg/kg/min
Title
Ejection fraction from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Title
Ejection fraction from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Title
Ejection fraction from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Title
Ejection fraction from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 15mcg/kg/min
Title
Ejection fraction from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 20mcg/kg/min
Title
Fractional shortening from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Title
Fractional shortening from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Title
Fractional shortening from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Title
Fractional shortening from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 15mcg/kg/min
Title
Fractional shortening from Echocardiography
Time Frame
After continuous infusion for more than 30 minutes at 20mcg/kg/min
Title
Tei index from Echocardiography
Description
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Time Frame
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Title
Tei index from Echocardiography
Description
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Time Frame
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Title
Tei index from Echocardiography
Description
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Time Frame
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Title
Tei index from Echocardiography
Description
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Time Frame
After continuous infusion for more than 30 minutes at 15mcg/kg/min
Title
Tei index from Echocardiography
Description
(Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)
Time Frame
After continuous infusion for more than 30 minutes at 20mcg/kg/min
Title
VTI (velocity time integral) from Echocardiography
Description
the area within the spectral curve and indicates how far blood travels during the flow period
Time Frame
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Title
VTI (velocity time integral) from Echocardiography
Description
the area within the spectral curve and indicates how far blood travels during the flow period
Time Frame
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Title
VTI (velocity time integral) from Echocardiography
Description
the area within the spectral curve and indicates how far blood travels during the flow period
Time Frame
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Title
VTI (velocity time integral) from Echocardiography
Description
the area within the spectral curve and indicates how far blood travels during the flow period
Time Frame
After continuous infusion for more than 30 minutes at 15mcg/kg/min
Title
VTI (velocity time integral) from Echocardiography
Description
the area within the spectral curve and indicates how far blood travels during the flow period
Time Frame
After continuous infusion for more than 30 minutes at 20mcg/kg/min

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Suk Kim, MD, PhD
Organizational Affiliation
Seoul National University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Dopamine in Neonate

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