ewborns with congenital diaphragmatic hernia: inhaled nitric oxide versus intravenous sildenafil: an international randomized controlled trial
Phase 4
Completed
- Conditions
- <p>congenital diaphragmatic hernia pulmonary hypertension newborn congenitale hernia diafragmatica pulmonale hypertensie pasgeborenen</p>CDH10028971
- Registration Number
- NL-OMON28811
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
Diagnosis of CDH and pulmonary hypertension defined as 2 of the following 4 criteria:
I. Systolic PAP> 2/3 systemic systolic pressure estimated by echocardiography
Exclusion Criteria
Severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a decision to stop or not to start life-saving medical treatment Severe cardiac anomaly, expected to need corrective surgery in the first 60 days of life (such as transposition of the great arteries, truncus arteriosus, coarctation aortae or double outlet right ventricle)
Renal anomalies associated with oligohydramnios Severe orthopaedic and skeletal deformities, which are likely to influence thoracic, and / or lung development (such as chest wall deformities and spine anomalies)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The absence of pulmonary hypertension on echocardiography on day 14 without pulmonary vasodilator therapy and without treatment failure in patients and/or death within the first 28 days of life</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Oxygenation index<br /><br>• Overall mortality<br /><br>• Incidence of treatment failure<br /><br>• Time on intervention drug (intervention drug free days on day 14)<br /><br>• Vasoactive-inotropic support score<br /><br>• Need for ECMO<br /><br>• Ventilator free days on day 28<br /><br>• Severity of pulmonary hypertension, using laboratory markers and tracheal aspirates for proteomic, metabolomics and biochemical analysis as a marker<br /><br>• The use of other medication given for pulmonary hypertension during the hospital admission<br /><br>• The use of pulmonary and/or cardiac medication at discharge and its total duration<br /><br>• Long-term pulmonary hypertension on echocardiography at 6 and 12 months<br /><br>• Chronic lung disease<br /><br>• The development of neurological abnormalities evaluated with ultrasound of the brain<br /><br>• External validation of sildenafil PKPD model</p><br>