NL-OMON50767
Recruiting
Phase 3
ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: ;an international randomized controlled trial - CoDiNOS trial
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites45 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 45
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 11 (—)
Inclusion Criteria
- •Diagnosis of CDH and pulmonary hypertension defined as 2 of the following 4
- •criteria: , I. PAP\> 2/3 systemic pressure estimated by echocardiography ,
- •II. RV dilatation/septal displacement, RV dysfunction \+/\- LV dysfunction , III.
- •Pre\-post ductal SpO2 difference \> 10% , IV. OI\>20\. , • Parental informed
- •consent, • Children born at or after a gestational age of 34 weeks , • Newborns
- •who received a fetal intervention may be included
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), • Severe anomalies of the central
- •nervous system, • iNO already started for postnatal transport
Investigators
Similar Trials
Active, not recruiting
Phase 1
ewborns with Congenital diaphragmatic hernia; iNO versus sildenafilEUCTR2017-000421-13-ITERASMUS MEDICAL CENTER330
Active, not recruiting
Phase 1
Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.Congenital diaphragmatic hernia with pulmonary hypertensionTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2017-000421-13-SEErasmus MC330
Active, not recruiting
Phase 1
Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.Congenital diaphragmatic hernia with pulmonary hypertensionTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2017-000421-13-ATErasmus MC330
Active, not recruiting
Phase 1
Treatment of high blood pressure in the lungs in newborns with a defect inthe diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.Congenital diaphragmatic hernia with pulmonary hypertensionTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2017-000421-13-NLErasmus MC90
Active, not recruiting
Phase 1
Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.EUCTR2017-000421-13-NOErasmus MC330