A study to investigate and stratify risk factors in the development of neonatal chronic lung disease in premature babies.

• Conditions: neonatal chronic lung disease bronchopulmonary dysplasia; MedDRA version: 14.1Level: PTClassification code 10063349Term: Endotracheal intubation complicationSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.1Level: LLTClassification code 10044107Term: Total parenteral nutritionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10018985Term: Haemorrhage intracranialSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10069719Term: Bacterial colonisationSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10021097Term: HypotensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: PTClassification code 10006093Term: BradycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10002974Term: ApnoeaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: LLTClassification code 10037395Term: Pulmonary haemorrhage of fetus or newbornSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-000811-23-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-28
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

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

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

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.

Study & Design

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