Neonates and Preterm InfantsPhase 2NCT04525495
Dopamine in Neonate
A Phase 2 study testing Dopamine in people with Neonates and Preterm Infants, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Neonates and Preterm Infants
- What is being tested?
- Dopamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2020to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital
- Infants who were diagnosed with hypotension
Who cannot join
- Congenital heart disease
- Chromosomal anomaly
- Treated with ECMO or CRRT
- Arrhythmia
- Hypovolemic state
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-744
About this study
Official title: 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.
- Conditions
- Neonates and Preterm Infants
- Being tested
- Dopamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopamineDrug
Dopamine treatment
| Study group | Role | What they receive |
|---|---|---|
| Dopamine treatment | Experimental | Not described Receives: Drug: Dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state concentration of dopamine (Css) at 2mcg/kg/min
dopamine drug level in blood
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Secondary outcomes (29)
Blood pressure in mmHg at 2mcg/kg/min
Systolic, diastolic and mean blood pressure in mmHg
Measured: 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
Measured: 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
Measured: 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
Measured: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Heart rate
Measured: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Heart rate
Measured: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Heart rate
Measured: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Heart rate
Measured: After continuous infusion for more than 30 minutes at 15mcg/kg/min
Heart rate
Measured: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Ejection fraction from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Ejection fraction from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Ejection fraction from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Ejection fraction from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 15mcg/kg/min
Ejection fraction from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Fractional shortening from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Fractional shortening from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Fractional shortening from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Fractional shortening from Echocardiography
Measured: After continuous infusion for more than 30 minutes at 15mcg/kg/min
Fractional shortening from Echocardiography
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates and Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Han-Suk Kim, MD, PhD, Principal investigator, Seoul National University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525495
- Sponsor's protocol ID
- DPMSNUH
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants
- ClinicalTrials.gov ID
- NCT04525495
- Acronym / sponsor ID
- DPMSNUH
- Conditions
- Neonates and Preterm Infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dopamine treatment | Experimental | Drug: Dopamine |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital
- Infants who were diagnosed with hypotension
Key exclusion criteria (5 listed)
- Congenital heart disease
- Chromosomal anomaly
- Treated with ECMO or CRRT
- Arrhythmia
- Hypovolemic state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DopamineDopamine treatment | Drug | Dopamine treatment |
Primary outcome
Steady state concentration of dopamine (Css) at 2mcg/kg/min
Time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 5mcg/kg/min
Time frame: 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
Time frame: 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
Time frame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 20mcg/kg/min
Time frame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
dopamine drug level in blood
29 secondary outcomes
Blood pressure in mmHg at 2mcg/kg/min
Time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Blood pressure in mmHg at 5mcg/kg/min
Time frame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Blood pressure in mmHg at 10mcg/kg/min
Time frame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Blood pressure in mmHg at 10mcg/kg/min
Time frame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Heart rate
Time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Heart rate
Time frame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Heart rate
Time frame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Heart rate
Time frame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
Heart rate
Time frame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Ejection fraction from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Ejection fraction from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Ejection fraction from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Ejection fraction from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
Ejection fraction from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Fractional shortening from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Fractional shortening from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Fractional shortening from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Fractional shortening from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
Fractional shortening from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Tei index from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
Tei index from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
Tei index from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
Tei index from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
Tei index from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
VTI (velocity time integral) from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min
VTI (velocity time integral) from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 5mcg/kg/min
VTI (velocity time integral) from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 10mcg/kg/min
VTI (velocity time integral) from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 15mcg/kg/min
VTI (velocity time integral) from Echocardiography
Time frame: After continuous infusion for more than 30 minutes at 20mcg/kg/min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Suk Kim, MD, PhD principal investigator
Seoul National University Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dopamine in people with Neonates and Preterm Infants, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady state concentration of dopamine (Css) at 2mcg/kg/min (time frame: After continuous infusion for more than 30 minutes at 2mcg/kg/min). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.