HYPOTENSION IN EXTREMELY PRETERM INFANTS MedDRA version: 9.1 Level: LLT Classification code 10049223 MedDRA version: 9.1 Level: LLT Classification code 10049223 MedDRA version: 9.1 Level: LLT Classification code 10049223 MedDRA version: 9.1 Level: LLT Classification code 10049223
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dopamine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical Form: Solution for in
Sponsors
AZIENDA UNITA` SANITARIA LOCALE N 12 DI VIAREGGIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: premature neonates 23-30 weeks gestation that present hypotension (BP =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Congenital heart diseases (except patent ductus arteriosus) identified by echocardiography; Severe /lethal congenital anomalies; Massive hemorrhage; neonates only offered supportive/palliative care; hypotension occurring > 3 days of life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome will be comparing, in terms of clinically relevant outcomes ( the combined end point of mortality or a severe neurological damage (severe IVH at day 7 or cystic PVL at day 28 or discharge, the policy of immediately treating extremely preterm neonates with hypotension starting with dopamine, with the policy of treating only those who also present clinical or ultrasound signs of low perfusion, starting with dobutamine.;Secondary Objective: Secondary outcomes will be the estimation, in the 2 groups, of the frequency of: Necrotizing enterocolitis Retinopathy of prematurity Bronchopulmonary displasia Renal impairment and hyperkalemia Other adverse events that could be caused by treatments (eg, arrhythmia, hypertension, seizures, thyroid hormonal effects) On a non-randomized subsample: measures of organ perfusion (eg, superior vena cava flow, pulmonary artery flow at ultrasound (US); right ventricular output; cardiovascular score), and relationship between BP and perfusion indices, and between US and clinical indices of perfusion.;Primary end point(s): The primary outcome will be the combined end point of mortality or a severe neurological outcome [severe intraventricular hemorrhage or cystic periventricular leucomalacia]. | — |
Countries
Italy
Outcome results
None listed