Dopamine in Neonate
Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 25, 2020
July 1, 2020
2.8 years
July 26, 2020
August 20, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (29)
Blood pressure in mmHg at 2mcg/kg/min
After continuous infusion for more than 30 minutes at 2mcg/kg/min
Blood pressure in mmHg at 5mcg/kg/min
After continuous infusion for more than 30 minutes at 5mcg/kg/min
Blood pressure in mmHg at 10mcg/kg/min
After continuous infusion for more than 30 minutes at 10mcg/kg/min
Blood pressure in mmHg at 10mcg/kg/min
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
- +24 more secondary outcomes
Study Arms (1)
Dopamine treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital
- Infants who were diagnosed with hypotension
You may not qualify if:
- Congenital heart disease
- Chromosomal anomaly
- Treated with ECMO or CRRT
- Arrhythmia
- Hypovolemic state
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Asan Medical Centercollaborator
- Severance Hospitalcollaborator
Study Sites (1)
Seoul National University Children's Hospital
Seoul, 110-744, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han-Suk Kim, MD, PhD
Seoul National University Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2020
First Posted
August 25, 2020
Study Start
April 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
August 25, 2020
Record last verified: 2020-07