294. Congenital diaphragmatic hernia Clinical trials / Disease details
Clinical trials : 16 / Drugs : 26 - (DrugBank : 5) / Drug target genes : 5 - Drug target pathways : 14
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05213676 (ClinicalTrials.gov) | January 1, 2023 | 27/1/2022 | Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The NoNO Trial - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative | Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The NoNO Trial - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative | Congenital Diaphragmatic Hernia | Drug: Inhaled Nitric Oxide (iNO) use;Other: De-implementation of Inhaled Nitric Oxide (iNO) use | The University of Texas Health Science Center, Houston | NULL | Not yet recruiting | N/A | 1 Month | All | 600 | Phase 4 | United States |
| 2 | NCT05201144 (ClinicalTrials.gov) | September 15, 2022 | 7/1/2022 | A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH) | A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH) | Congenital Diaphragmatic Hernia;Pulmonary Hypertension | Drug: Sildenafil Oral Suspension;Other: Placebo | University of Utah | NULL | Recruiting | N/A | N/A | All | 40 | Phase 2 | United States |
| 3 | ChiCTR2000037331 | 2020-09-01 | 2020-08-28 | AI-assisted diagnosis and treatment engine based on a fully structured congenital diaphragmatic hernia disease database | AI-assisted diagnosis and treatment engine based on a fully structured congenital diaphragmatic hernia disease database | Congenital diaphragmatic hernia | intervention group:sildenafil + conventional therapy;control group:conventional therapy; | Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Recruiting | 0 | 5 | Both | intervention group:100;control group:100; | China | |
| 4 | EUCTR2017-000421-13-IT (EUCTR) | 20/03/2020 | 06/10/2020 | Newborns with Congenital diaphragmatic hernia; iNO versus sildenafil | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS Trial | Congenital diaphragmatic hernia with pulmonary hypertension MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: REVATIO - 0.8 MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 1 FLACONCINO DA 20 ML Product Name: Sildenafil Product Code: [na] INN or Proposed INN: Sildenafil Trade Name: INALOSSIN - 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO BOMBOLA IN ALLUMINIO CON VALVOLA VI DA 20 LITRI Product Name: INALOSSIN 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO Product Code: [na] INN or Proposed INN: OSSIDO DI AZOTO Other descriptive name: Nitric oxide | ERASMUS MEDICAL CENTER | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Spain;Belgium;Austria;Norway;Netherlands;Germany;Italy;Sweden | ||
| 5 | NCT04031508 (ClinicalTrials.gov) | August 12, 2019 | 8/7/2019 | Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH | Effect of a Parenteral Emulsion With LC-PUFA Omega 3 on Clinical Outcomes, Inflammatory and Oxidative Stress Markers in Neonates With Persistent Pulmonary Hypertension Associated With Congenital Diaphragmatic Hernia | Pulmonary Hypertension of Newborn;Diaphragm Defect | Combination Product: lipid injectable emulsion with Fish oil | Coordinación de Investigación en Salud, Mexico | University of Southampton;Universidad Nacional Autonoma de Mexico | Recruiting | 1 Hour | 15 Days | All | 70 | Phase 2 | Mexico |
| 6 | EUCTR2017-000421-13-BE (EUCTR) | 07/02/2019 | 19/02/2019 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE Trade Name: Neophyr 1000ppm mol/mol | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Austria;Netherlands | ||
| 7 | NCT03526588 (ClinicalTrials.gov) | August 1, 2018 | 27/4/2018 | Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH) | Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH) | Congenital Diaphragmatic Hernia | Biological: Autologous umbilical cord blood | The University of Texas Health Science Center, Houston | Texas Medical Center Regenerative Medicine Consortium | Recruiting | N/A | 7 Days | All | 20 | Phase 1 | United States |
| 8 | EUCTR2017-000421-13-AT (EUCTR) | 13/07/2018 | 08/05/2018 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection INN or Proposed INN: Sildenafil Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 4 | Austria;Netherlands | ||
| 9 | NCT02951130 (ClinicalTrials.gov) | August 22, 2017 | 14/10/2016 | Milrinone in Congenital Diaphragmatic Hernia | Milrinone in Congenital Diaphragmatic Hernia | Congenital Diaphragmatic Hernia;Persistent Pulmonary Hypertension of the Newborn;Hypoxemic Respiratory Failure;Pulmonary Hypoplasia | Drug: Milrinone;Drug: Placebo (5% Dextrose) | NICHD Neonatal Research Network | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Recruiting | N/A | 168 Hours | All | 66 | Phase 2 | United States |
| 10 | EUCTR2017-000421-13-NL (EUCTR) | 27/07/2017 | 07/06/2017 | Treatment of high blood pressure in the lungs in newborns with a defect inthe diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxideversus intravenous Sildenafil:an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belgium;Austria;Norway;Netherlands;Sweden | ||
| 11 | NCT02175264 (ClinicalTrials.gov) | June 2014 | 25/6/2014 | Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia | Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia | Isolated Non Syndromic Left CDH With Postero Lateral Diaphragmatic Defect With Good Perinatal Outcome | Genetic: Blood sample | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 3 Months | N/A | Both | 73 | N/A | France |
| 12 | EUCTR2013-002026-22-NL (EUCTR) | 24/10/2013 | 27/06/2013 | Adminstration of omeprazole by rectiole or oral tablet for the treatment of reflux disease in neonates and infants with a closure of the esophagus or a congenital opening in the diaphragm. | Rectal and oral omeprazole treatment of gastroesophageal reflux in infants with esophageal atresia or congenital diaphragmatic hernia.A pharmacodynamic and pharmacokinetic study - NEOPREMEC | GORD,;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Losec Product Name: Omeprazol Product Code: NA Trade Name: Losec Product Name: Omeprazol Product Code: NA | ErasmusMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 13 | NCT02453750 (ClinicalTrials.gov) | February 2012 | 21/5/2015 | Airway Inflammation in Congenital Diaphragmatic Hernia Patients | Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients | Congenital Diaphragmatic Hernia | Drug: Hypersaline;Drug: Bronchodilator Response | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | All | 21 | N/A | Canada |
| 14 | NCT00226044 (ClinicalTrials.gov) | September 2005 | 22/9/2005 | Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants. | Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study. | Gastroesophageal Reflux;Esophageal Atresia;Hernia, Diaphragmatic | Drug: Omeprazole rectally 1mg/kg | Rijnstate Hospital | Erasmus Medical Center | Completed | 6 Weeks | 3 Months | All | 17 | Phase 3 | Netherlands |
| 15 | EUCTR2017-000421-13-NO (EUCTR) | 11/01/2018 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE Trade Name: Neophyr 1000ppm mol/mol | Erasmus MC | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | Belgium;Austria;Netherlands;Norway | |||
| 16 | EUCTR2017-000421-13-SE (EUCTR) | 11/09/2018 | Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. | Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial | Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: revatio 0.8mg/ml solution for injection Trade Name: INOmax 800ppm mol/mol inhalatiegas INN or Proposed INN: NITRIC OXIDE | Erasmus MC | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | Belgium;Austria;Norway;Netherlands;Sweden |