An international multicentre study of a new formulation of Dobutamine to look into how babies are handling the drug in their body and to observe the way different hospitals use this and other drugs for treating circulatory failure with the aim of designing a larger randomized trial.

An international multicentre open-label comparative therapeutic exploratory trial to investigate the role of a new neonatal formulation of dobutamine in the treatment of haemodynamic insufficiency in the immediate postnatal period

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002845-12-ES

Enrollment

338

Registered

2013-11-12

Start date

2013-12-03

Completion date

Unknown

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

babies with evidence of haemodynamic insufficiency within 72 hours after birth

Interventions

Product Name: Dobutamine Neonatal Formulation Pharmaceutical Form: Solution for infusion INN or Proposed INN: DOBUTAMINE CAS Number: 34368-04-2 Concentration unit: mg/ml milligram(s)/millilitre Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -neonates 24 to 32+6 weeks´ gestation, -postnatal age 4 sec; (iv) Lactate > 4 mmol/l (v) Base excess =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: NeoCirc-001 - -non-viability; -congenital hydrops or malformations likely to affect cardiovascular adaptation; -surgery planned within 72 hours of birth; -chromosomal anomalies; -informed consent form (ICF) not signed.

Design outcomes

Primary

Measure	Time frame
Main Objective: NeoCirc-001 - The primary objective is to answer some important questions required for the design of a forthcoming placebo-controlled trial, which will evaluate the effectiveness of a new neonatal formulation of dobutamine to treat haemodynamic insufficiency in the first 72 hours after birth in babies born at less than 33 weeks gestation (see issues requiring consideration below).This population will be observed with a view to determining which diagnostic measures lead to treatment decisions. The primary outcome is death or worst cranial ultrasound (CUS) appearances at or before 36 weeks gestation and will be observed in all cases.;Secondary Objective: NA;Primary end point(s): A composite endpoint is defined as follows: a neonate is called a failure as soon as one of the following is true at or before gestational age 36 (+/-2 weeks), where all surviving patients will have a cranial ultrasound (CUS)- 1. Neonate dies, or 2. Intraventricular haemorrhage (IVH) grades 3 or 4, or 3. cystic and non-cystic periventricular leukomalacia (PVL), or 4. porencephalic cysts, ventriculomegaly, or cerebellar haemorrhage.;Timepoint(s) of evaluation of this end point: A first CUS scan will be done as soon as possible at enrolment, preferably within the first 6 hours, but always before treatment is started. Subsequent scans will be done between 48 to 72 hours of treatment, at postnatal day 7 (±1), day 14 (±1), day 35 (±1) and at 36 (± 2) week?s gestation.	—

Measure

Time frame

Main Objective: NeoCirc-001 - The primary objective is to answer some important questions required for the design of a forthcoming placebo-controlled trial, which will evaluate the effectiveness of a new neonatal formulation of dobutamine to treat haemodynamic insufficiency in the first 72 hours after birth in babies born at less than 33 weeks gestation (see issues requiring consideration below).This population will be observed with a view to determining which diagnostic measures lead to treatment decisions. The primary outcome is death or worst cranial ultrasound (CUS) appearances at or before 36 weeks gestation and will be observed in all cases.;Secondary Objective: NA;Primary end point(s): A composite endpoint is defined as follows: a neonate is called a failure as soon as one of the following is true at or before gestational age 36 (+/-2 weeks), where all surviving patients will have a cranial ultrasound (CUS)- 1. Neonate dies, or 2. Intraventricular haemorrhage (IVH) grades 3 or 4, or 3. cystic and non-cystic periventricular leukomalacia (PVL), or 4. porencephalic cysts, ventriculomegaly, or cerebellar haemorrhage.;Timepoint(s) of evaluation of this end point: A first CUS scan will be done as soon as possible at enrolment, preferably within the first 6 hours, but always before treatment is started. Subsequent scans will be done between 48 to 72 hours of treatment, at postnatal day 7 (±1), day 14 (±1), day 35 (±1) and at 36 (± 2) week?s gestation.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Clinical and research parameters will be measured while the infants are receiving cardiovascular support;Secondary end point(s): -Clinical parameters The clinical condition of all the participants will be monitored using regular assessments (at 5 to 7 -hourly intervals) of: Haemodynamic parameters (blood pressure, heart rate, pulse oximetry) CRT Urine output Plasma lactate concentration and base excess -Lactate, base excess and urine output will be assessed at the next clinically indicated opportunity to avoid unjustified burdens on the babies to mandate non-clinically indicated procedures. Assessments at clinically indicated times override the 6 hourly intervals described above. -Optional research parameters available in a selection of centres These parameters will be measured in selected centres at enrolment and at regular intervals while the infant is on cardiovascular support: Echo-D derived SVC flow and RVO (every 6-to-12 h). NIRS (continuous monitoring). aEEG (continuous monitoring).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Clinical and research parameters will be measured while the infants are receiving cardiovascular support;Secondary end point(s): -Clinical parameters The clinical condition of all the participants will be monitored using regular assessments (at 5 to 7 -hourly intervals) of: Haemodynamic parameters (blood pressure, heart rate, pulse oximetry) CRT Urine output Plasma lactate concentration and base excess -Lactate, base excess and urine output will be assessed at the next clinically indicated opportunity to avoid unjustified burdens on the babies to mandate non-clinically indicated procedures. Assessments at clinically indicated times override the 6 hourly intervals described above. -Optional research parameters available in a selection of centres These parameters will be measured in selected centres at enrolment and at regular intervals while the infant is on cardiovascular support: Echo-D derived SVC flow and RVO (every 6-to-12 h). NIRS (continuous monitoring). aEEG (continuous monitoring).

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Countries

Hungary, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactPellicer

Adelina

apellicer.hulp@salud.madrid.org+34 917277416

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026