Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
3
Neonates with haemodynamic insufficiency
To determine the minimum effective dose of dobutamine required to treat low SVC flow (<51 ml/k/min) in very preterm infants (short- term pharmacodynamic (PD) objective).
Key facts
- Sponsor
- Hospital Universitario La Paz
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 20 Jun 2024 → ongoing
- Decision date (initial)
- 2023-06-29
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
To determine the minimum effective dose of dobutamine required to treat low SVC flow (<51 ml/k/min) in very preterm infants (short- term pharmacodynamic (PD) objective).
Secondary objectives 3
- To assess the proportion of infants who maintain an acceptable haemodynamic status with the dobutamine infusion alone in the first 72h from birth (efficacy)
- To evaluate the safety of dobutamine for the whole study population as well as for the seven treatment groups separately
- To determine the individual variables that explain the interindividual pharmacokinetic (PK)/PD variability.
Conditions and MedDRA coding
Neonates with haemodynamic insufficiency
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase I-II, Single centre, dose finding trial to establish the minimum effective dose of dobutamine Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat haemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks’ gestation during transitional circulation (first 72 hours from birth).
It is a low-intervention clinical trial.
|
Randomised Controlled | None | ARM A: 5 mcg/kg/min dobutamine intravenous. ARM B: 7,5 mcg/kg/min cobutamine intravenous. ARM C: 10 mcg/kg/min cobutamine intravenous. ARM D: 12,5 mcg/kg/min cobutamine intravenous. ARM E: 15 mcg/kg/min cobutamine intravenous. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Born up to 32(+6) weeks gestation
- Presence of haemodynamic 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 as described in section 5.4.
Exclusion criteria 6
- 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 carrying chromosomal anomalies
- Lack of parental signed informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Short-term PD endpoint: Minimum dobutamine dose to reach and maintain an SVC flow above 55 ml/k/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose [A].
Secondary endpoints 3
- Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status [B] with the dobutamine infusion alone in the first 72 hours from birth.
- Absolute and relative frequencies of adverse events (AEs) and severe adverse events (SAEs), to be recorded and compared between groups
- To determine the correlation between PK and PD.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dobutamine Generis 12.5 mg/mL Solution for Infusion
PRD10257713 · Product
- Active substance
- Dobutamine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS PERFUSION USE
- Authorisation status
- Authorised
- ATC code
- C01CA07 — DOBUTAMINE
- Marketing authorisation
- AA1500/00301
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario La Paz
- Sponsor organisation
- Hospital Universitario La Paz
- Address
- Paseo Castellana 261
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Adelina Pellicer
Public contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Adelina Pellicer
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 30 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario La Paz
Neonatología, Paseo Castellana 261, 28046, Madrid
Hospital Universitario 12 De Octubre
Neonatología, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Quironsalud Madrid
Neonatología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-06-20 | 2024-11-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 190124_AP_D1_Protocol_Neocirc_002_v2_0_includes MNR1 FINAL_redacted | 2.0 NSM-1 |
| Protocol (for publication) | 190124_AP_D1_Protocol_Neocirc_002_v3_0_FINAL_redacted | 3.0. |
| Protocol (for publication) | AP_D1_Protocol_Neocirc_002_redacted | 2.0. |
| Protocol (for publication) | D1_Protocol_Neocirc_002_2023_504915_34_00_redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arragement_NEOCIRC 002 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_NEOCIRC_002_ICF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_NEOCIRC_002_ICF_Deferred | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_NEOCIRC_002_ICF_Opt_out | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | FT_61952 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Neocirc_002_2023_504915_34_00 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-18 | Spain | Acceptable 2023-06-29
|
2023-06-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-22 | Spain | Acceptable 2024-02-19
|
2024-02-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-06 | Spain | Acceptable 2024-02-19
|
2024-06-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-05 | Spain | Acceptable | 2025-08-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-23 | Spain | Acceptable 2026-02-19
|
2026-02-20 |