acute hypoxic respiratory failure in children ventilated on paediatric intensive care MedDRA version: 12.1 Level: PT Classification code 10040047 Term: Sepsis MedDRA version: 12.1 Level: PT Classification code 10018985 Term: Haemorrhage intracranial MedDRA version: 12.1 Level: PT Classification code 10006093 Term: Bradycardia MedDRA version: 12.1 Level: PT Classification code 10021097 Term: Hypotension MedDRA version: 12.1 Level: PT Classification code 10006475 Term: Bronchopulmonary dyspla
Conditions
Interventions
Trade Name: Curosurf
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
Sponsors
Southampton University Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Age less than 16 years Ventilated on PICU (controls and cases) CASES: Acute hypoxic respiratory failure (AHRF) (controls) as defined by degree of observed hypoxia assessed using the P/F ratio P/F ratio of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Failure to obtain informed consent from the child's parents Extreme cardiovascular instability Intractable intra cranial hypertension Pulmonary haemorrhages Persistent pulmonary air leak Advanced malignancy Cardiopulmonary resuscitation Children not likely to survive the time period of the intervention Patients who are pregnant Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted. Participation in a investigational clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does a single dose of exogenous surfactant (100mg/kg CUROSURF® (poractant alfa) administered via the endotracheal tube substantially alter surfactant metabolism in children with AHRF;Secondary Objective: a) Can choline chloride (trimethyl-D9) be use effectively to study surfactant metabolism in children with AHRF? b) Is diminished production a major cause of AHRF in children? c) Is there significant hydrolysis and oxidative damage of surfactant phospholipid in children with AHRF? ;Primary end point(s): The primary end point is the measurement of the rate of synthesis of surfactant in healthy lungs compared with the rate in lungs of children with acute hypoxic respiratory failure before and after the installation of curosurf. | — |
Countries
United Kingdom
Outcome results
None listed