Status:
TERMINATED
Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Collaborating Sponsors:
Hospital Universitario La Paz
Brighton and Sussex University Hospitals NHS Trust
Conditions:
Shock
Eligibility:
All Genders
Up to 72 years
Phase:
PHASE1
PHASE2
Brief Summary
Haemodynamic insufficiency after birth is seen commonly in babies born prematurely and is associated with adverse outcomes. In current clinical practice, a combination of blood pressure and clinical s...
Eligibility Criteria
Inclusion
- Inclusion criteria for NeoCirc-001, 001A and 001B -
- Target population for informed consent:
- neonates 24 to 32+6 weeks´ gestation,
- postnatal age \<72 hours;
- Infants eligible for circulatory failure pathway:
- parental informed consent obtained;
- The infants will be assessed, as per routine clinical practice, for clinical signs indicating infants at risk of poor perfusion, and will be recruited if they develop haemodynamic insufficiency defined as: either two or more of: (i) Mean blood pressure (MBP) \< gestational age (GA)-1 mmHg (invasive/non-invasive, two readings 15 min apart); (ii) SVC flow \< 51 ml/kg/min; (iii) capillary refill time (CRT) \> 4 sec; (iv) Lactate \> 4 mmol/l (v) Base excess \<-9 mmol/l or: MBP \< GA -5 mmHg (invasive/non-invasive, two readings 15 min apart)
- Exclusion Criteria: NeoCirc-001, 001A and 001B -
- 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.
Exclusion
Key Trial Info
Start Date :
May 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03311178
Start Date
May 30 2014
End Date
October 10 2017
Last Update
October 17 2017
Active Locations (1)
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1
La Paz University Hospital, Department of Neonatology
Madrid, Spain, 28046