Infant, Premature, DiseasesPhase 1/2NeoCirc-002NCT06878742
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
A Phase 1/2 study testing Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min and Intravenous dobutamine 10 mcg/kg/min in people with Infant, Premature, Diseases and Circulatory and Respiratory Physiological Phenomena, run by Instituto de Investigación Hospital Universitario La Paz at 3 sites in Spain.
Trial summary
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth). Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena
- What is being tested?
- Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min and Intravenous dobutamine 10 mcg/kg/min
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSpain
- Study dates
- 24 Jun 2024to Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born with up to 32(+6) weeks gestation
- Presence of hemodynamic insufficiency, defined as SVC flow <51 ml/kg/min.
- Provision of signed and dated informed consent form by father/mother or legally designated representative, which can be given antenatally.
Who cannot join
- Neonates considered non-viable, with a clinical decision not to provide life support
- Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
- Infants already on dobutamine treatment
- Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects)
- Infants with chromosomal anomalies
- Lack of parental signed informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Quironsalud
Madrid, 28002
Fernando Cabañas, MD, Fernando.cabanas@quironsalud.es
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
María López, MD, maríamaestro@gmail.com
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Adelina Pellicer, MD, 917277416, adelina.pellicer@salud.madrid.org
About this study
Official title: Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).
- Being tested
- Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min, Intravenous dobutamine 10 mcg/kg/min, Intravenous dobutamine 12.5 mcg/kg/min, Intravenous dobutamine 15 mcg/kg/min
- Keywords
- Hemodynamic insuffiency, Low superior vena cava flow
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous dobutamine 5 mcg/kg/minDrug
Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.
Intravenous dobutamine 7.5 mcg/kg/minDrug
Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.
Intravenous dobutamine 10 mcg/kg/minDrug
Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.
Intravenous dobutamine 12.5 mcg/kg/minDrug
Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.
Intravenous dobutamine 15 mcg/kg/minDrug
Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine dose A | Experimental | Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. Receives: Drug: Intravenous dobutamine 5 mcg/kg/min |
| Dobutamine dose B | Experimental | Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. Receives: Drug: Intravenous dobutamine 7.5 mcg/kg/min |
| Dobutamine dose C | Experimental | Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. Receives: Drug: Intravenous dobutamine 10 mcg/kg/min |
| Dobutamine dose D | Experimental | Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. Receives: Drug: Intravenous dobutamine 12.5 mcg/kg/min |
| Dobutamine dose E | Experimental | Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. Receives: Drug: Intravenous dobutamine 15 mcg/kg/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min
Short-term pharmacodynamics (PD) endpoint: Minimum dobutamine dose to reach and maintain a superior vena cava (SVC) flow above 55 ml/kg/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose.
The effective start of the infusion (t0) will be calculated as the time at which the infusion pump is switched on plus the empirical value for the interval arising from the dead space. We summarize t0 as "the time at which dobutamine is expected to reach the circulation"
Measured: 1 and 3 hours
Secondary outcomes (2)
Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status
Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status with the dobutamine infusion alone in the first 72 hours from birth.
Acceptable hemodynamic status is defined as the achievement and maintenance of dose success during the first 72 h from birth. The loss of such acceptable haemodynamic status occurs whenever there is a change in therapeutic strategy that involves cardiovascular treatment other than dobutamine alone due to exceeded safety parameters, treatment failure of the investigational infusion or the need for rescue treatment or death; any additional fluid bolus is considered as cardiovascular treatment.
Measured: 72 hours
Absolute and relative frequencies of adverse events and severe adverse events
Absolute and relative frequencies of adverse events (AEs) and severe adverse events (SAEs), to be recorded and compared between groups.
AEs are defined as any untoward medical occurrence in a patient or clinical investigation patients administered a medicinal product, which does not necessarily have a causal relationship with this treatment (the study medication).
SAEs are defined as any untoward medical occurrence that at any dose:
- Results in death,
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity, or
- Is a congenital anomaly/birth defect.
- Other important medical events.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start24 Jun 2024
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- NeoCirc-002 is a single center, dose finding trial to define the minimum effective dose of dobutamine to treat early hemodynamic insufficiency in the preterm infant (less than 33 completed weeks' gestation), defined as presence of low SVC flow (\<51 ml/k/min) within the first 72 hours from birth. The trial is a low-intervention clinical trial since dobutamine is the standard treatment for circulatory failure in preterm infants during transitional circulation, the dosages studied are within the standard therapeutic range, and the diagnostic supplementary procedures are in routine clinical practice.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878742
- Sponsor's protocol ID
- HULP 6422
- Acronym
- NeoCirc-002
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant
- ClinicalTrials.gov ID
- NCT06878742
- Acronym / sponsor ID
- NeoCirc-002 / HULP 6422
- Keywords
- Hemodynamic insuffiency, Low superior vena cava flow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 Mar 2025 (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.
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- NeoCirc-002 is a single center, dose finding trial to define the minimum effective dose of dobutamine to treat early hemodynamic insufficiency in the preterm infant (less than 33 completed weeks' gestation), defined as presence of low SVC flow (<51 ml/k/min) within the first 72 hours from birth. The trial is a low-intervention clinical trial since dobutamine is the standard treatment for circulatory failure in preterm infants during transitional circulation, the dosages studied are within the standard therapeutic range, and the diagnostic supplementary procedures are in routine clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Dobutamine dose A | Experimental | Drug: Intravenous dobutamine 5 mcg/kg/minIntravenous dobutamine will be administered at a dose of 5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. |
| Dobutamine dose B | Experimental | Drug: Intravenous dobutamine 7.5 mcg/kg/minIntravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. |
| Dobutamine dose C | Experimental | Drug: Intravenous dobutamine 10 mcg/kg/minIntravenous dobutamine will be administered at a dose of 10 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. |
| Dobutamine dose D | Experimental | Drug: Intravenous dobutamine 12.5 mcg/kg/minIntravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. |
| Dobutamine dose E | Experimental | Drug: Intravenous dobutamine 15 mcg/kg/minIntravenous dobutamine will be administered at a dose of 15 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies. |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born with up to 32(+6) weeks gestation
- Presence of hemodynamic insufficiency, defined as SVC flow <51 ml/kg/min.
- Provision of signed and dated informed consent form by father/mother or legally designated representative, which can be given antenatally.
Key exclusion criteria (6 listed)
- Neonates considered non-viable, with a clinical decision not to provide life support
- Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
- Infants already on dobutamine treatment
- Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects)
- Infants with chromosomal anomalies
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 |
|---|---|---|
| Intravenous dobutamine 5 mcg/kg/minIntravenous dobutamine will be administered at a dose of 5 mcg/kg/min. | Drug | Dobutamine dose A |
| Intravenous dobutamine 7.5 mcg/kg/minIntravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. | Drug | Dobutamine dose B |
| Intravenous dobutamine 10 mcg/kg/minIntravenous dobutamine will be administered at a dose of 10 mcg/kg/min. | Drug | Dobutamine dose C |
| Intravenous dobutamine 12.5 mcg/kg/minIntravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. | Drug | Dobutamine dose D |
| Intravenous dobutamine 15 mcg/kg/minIntravenous dobutamine will be administered at a dose of 15 mcg/kg/min. | Drug | Dobutamine dose E |
Primary outcome
Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min
Time frame: 1 and 3 hours
Short-term pharmacodynamics (PD) endpoint: Minimum dobutamine dose to reach and maintain a superior vena cava (SVC) flow above 55 ml/kg/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose. The effective start of the infusion (t0) will be calculated as the time at which the infusion pump is switched on plus the empirical value for the interval arising from the dead space. We summarize t0 as "the time at which dobutamine is expected to reach the circulation"
2 secondary outcomes
Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status
Time frame: 72 hours
Absolute and relative frequencies of adverse events and severe adverse events
Time frame: Through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min and Intravenous dobutamine 10 mcg/kg/min in people with Infant, Premature, Diseases and Circulatory and Respiratory Physiological Phenomena, run by Instituto de Investigación Hospital Universitario La Paz at 3 sites in Spain.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adelina Pellicer, MD (917277416, adelina.pellicer@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min (time frame: 1 and 3 hours). 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 17 Mar 2025.