Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

NCT01605279

Hemodynamic Instability

COMPLETED PHASE2

Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period

NCT03311178

Shock

TERMINATED PHASE1/PHASE2

Early Blood Pressure Management in Extremely Premature Infants

NCT00874393

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +3 more

COMPLETED PHASE1

Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)

NCT07322133

Hypotension and Shock Pulmonary Hypertension of the Newborn (PPHN) Hypoxemic Respiratory Failure

RECRUITING PHASE4

Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns

NCT06280872

Premature Birth Respiratory Distress Syndrome in Premature Infant Sepsis +3 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant, Premature, Diseases Circulatory and Respiratory Physiological Phenomena

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dobutamine dose A

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.

Group Type EXPERIMENTAL

Intravenous dobutamine 5 mcg/kg/min

Intervention Type DRUG

Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.

Dobutamine dose B

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.

Group Type EXPERIMENTAL

Intravenous dobutamine 7.5 mcg/kg/min

Intervention Type DRUG

Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.

Dobutamine dose C

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.

Group Type EXPERIMENTAL

Intravenous dobutamine 10 mcg/kg/min

Intervention Type DRUG

Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.

Dobutamine dose D

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.

Group Type EXPERIMENTAL

Intravenous dobutamine 12.5 mcg/kg/min

Intervention Type DRUG

Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.

Dobutamine dose E

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.

Group Type EXPERIMENTAL

Intravenous dobutamine 15 mcg/kg/min

Intervention Type DRUG

Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous dobutamine 5 mcg/kg/min

Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.

Intervention Type DRUG

Intravenous dobutamine 7.5 mcg/kg/min

Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.

Intervention Type DRUG

Intravenous dobutamine 10 mcg/kg/min

Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.

Intervention Type DRUG

Intravenous dobutamine 12.5 mcg/kg/min

Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.

Intervention Type DRUG

Intravenous dobutamine 15 mcg/kg/min

Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No