Pulmonary surfactant (S) biology in ventilated children on a paediatric intensive care unit with acute (A) hypoxic respiratory (R) failure- a pilot (P) study (S): (SARPS) - SARPS

• Conditions: MedDRA version: 12.1Level: PTClassification code 10040047Term: Sepsis; MedDRA version: 12.1Level: PTClassification code 10011705Term: Cyanosis neonatal; MedDRA version: 12.1Level: PTClassification code 10021097Term: Hypotension; MedDRA version: 12.1Level: PTClassification code 10033318Term: Oxygen saturation decreased; acute hypoxic respiratory failure in children ventilated on paediatric intensive care; MedDRA version: 12.1Level: PTClassification code 10018985Term: Haemorrhage intracranial; MedDRA version: 12.1Level: PTClassification code 10002974Term: Apnoea; MedDRA version: 12.1Level: PTClassification code 10063349Term: Endotracheal intubation complication; MedDRA version: 12.1Level: PTClassification code 10037394Term: Pulmonary haemorrhage; MedDRA version: 12.1Level: PTClassification code 10014408Term: Electroencephalogram abnormal

• Registration Number: EUCTR2010-023668-42-GB
• Lead Sponsor: Southampton University Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 300 mmHg (Calculated by dividing the arterial partial pressure of oxygen (PaO2 = P) by the fractional concentration of oxygen in the inspired gas mixture delivered by the ventilator (FiO2 = F)
CONTROLS: Ventilated children who do not meet the criteria for AHRF as defined above
Informed consent from the child's parents

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?<br>b) Is diminished production a major cause of AHRF in children? <br><br>c) Is there significant hydrolysis and oxidative damage of surfactant phospholipid in children with AHRF? <br>;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.