neonatal chronic lung disease bronchopulmonary dysplasia MedDRA version: 14.1 Level: PT Classification code 10063349 Term: Endotracheal intubation complication System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1 Level: LLT Classification code 10044107 Term: Total parenteral nutrition System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10018985 Term: Haemorrhage intracranial System Orga
Conditions
Interventions
Trade Name: Curosurf
Product Name: Curosurf
Pharmaceutical Form: Endotracheopulmonary instillation, solution
INN or Proposed INN: PORACTANT ALPHA
CAS Number: 129069-19-8
Concentration unit: mg/ml mill
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All infants born at less than 28 completed weeks gestation will be eligible for recruitment. They will be less than 72 hours old, ventilated on the neonatal intensive care unit and have full informed consent from parent or guardian. Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Infants will be excluded if there are clinical concerns with extreme cardiovascular instability, pulmonary haemorrhage, persistent air leak, an identified severe congenital abnormality. Also the infant will be excluded if it is unlikely to survive the time period of intervention or if there has been failure to obtain consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What are the interactions of the significant risk factors for neonatal Chronic Lung Disease? We hope to piece together the different factors (mechanical, nutritional, microbiological and surfactant-based) and to use novel laboratory techniques to identify significant differences between infants who develop chronic lung disease and those who do not.;Secondary Objective: The secondary and follow up questions from this research project would include: “Is there a detectable difference, either clinically or in the laboratory, in how the surfactant systems of infants who subsequently develop severe chronic lung disease differ from those infants who do not?” and “Will an extra dose of surfactant medication given to infants identified to be at increased risk help to shorten the time they may have spent on the ventilator and in the longer term reduce their risk of developing nCLD?;Primary end point(s): Outcome measure is the development and severity of neonatal Chronic Lung Disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measurement of the rate of synthesis of surfactant in preterm lungs after instillation of extra dose of surfactant. | — |
Countries
United Kingdom
Contacts
Public ContactGoss
Southampton University Hospitals NHS Trust
Outcome results
None listed