294. 先天性横隔膜ヘルニア Congenital diaphragmatic hernia Clinical trials / Disease details


臨床試験数 : 16 薬物数 : 26 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 14

  
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1NCT05213676
(ClinicalTrials.gov)
January 1, 202327/1/2022Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The NoNO Trial - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established CollaborativeInhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The NoNO Trial - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established CollaborativeCongenital Diaphragmatic HerniaDrug: Inhaled Nitric Oxide (iNO) use;Other: De-implementation of Inhaled Nitric Oxide (iNO) useThe University of Texas Health Science Center, HoustonNULLNot yet recruitingN/A1 MonthAll600Phase 4United States
2NCT05201144
(ClinicalTrials.gov)
September 15, 20227/1/2022A 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 HypertensionDrug: Sildenafil Oral Suspension;Other: PlaceboUniversity of UtahNULLRecruitingN/AN/AAll40Phase 2United States
3ChiCTR2000037331
2020-09-012020-08-28AI-assisted diagnosis and treatment engine based on a fully structured congenital diaphragmatic hernia disease databaseAI-assisted diagnosis and treatment engine based on a fully structured congenital diaphragmatic hernia disease database Congenital diaphragmatic herniaintervention group:sildenafil + conventional therapy;control group:conventional therapy;Xinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineNULLRecruiting05Bothintervention group:100;control group:100;China
4EUCTR2017-000421-13-IT
(EUCTR)
20/03/202006/10/2020Newborns with Congenital diaphragmatic hernia; iNO versus sildenafilNewborns 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 CENTERNULLNot RecruitingFemale: yes
Male: yes
330Phase 3Spain;Belgium;Austria;Norway;Netherlands;Germany;Italy;Sweden
5NCT04031508
(ClinicalTrials.gov)
August 12, 20198/7/2019Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDHEffect 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 HerniaPulmonary Hypertension of Newborn;Diaphragm DefectCombination Product: lipid injectable emulsion with Fish oilCoordinación de Investigación en Salud, MexicoUniversity of Southampton;Universidad Nacional Autonoma de MexicoRecruiting1 Hour15 DaysAll70Phase 2Mexico
6EUCTR2017-000421-13-BE
(EUCTR)
07/02/201919/02/2019Treatment 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 MCNULLAuthorised-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): noBelgium;Austria;Netherlands
7NCT03526588
(ClinicalTrials.gov)
August 1, 201827/4/2018Umbilical 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 HerniaBiological: Autologous umbilical cord bloodThe University of Texas Health Science Center, HoustonTexas Medical Center Regenerative Medicine ConsortiumRecruitingN/A7 DaysAll20Phase 1United States
8EUCTR2017-000421-13-AT
(EUCTR)
13/07/201808/05/2018Treatment 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
330Phase 4Austria;Netherlands
9NCT02951130
(ClinicalTrials.gov)
August 22, 201714/10/2016Milrinone in Congenital Diaphragmatic HerniaMilrinone in Congenital Diaphragmatic HerniaCongenital Diaphragmatic Hernia;Persistent Pulmonary Hypertension of the Newborn;Hypoxemic Respiratory Failure;Pulmonary HypoplasiaDrug: Milrinone;Drug: Placebo (5% Dextrose)NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)RecruitingN/A168 HoursAll66Phase 2United States
10EUCTR2017-000421-13-NL
(EUCTR)
27/07/201707/06/2017Treatment 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belgium;Austria;Norway;Netherlands;Sweden
11NCT02175264
(ClinicalTrials.gov)
June 201425/6/2014Genetic Basis of Non Syndromic Congenital Diaphragmatic HerniaGenetic Basis of Non Syndromic Congenital Diaphragmatic HerniaIsolated Non Syndromic Left CDH With Postero Lateral Diaphragmatic Defect With Good Perinatal OutcomeGenetic: Blood sampleAssistance Publique - Hôpitaux de ParisNULLCompleted3 MonthsN/ABoth73N/AFrance
12EUCTR2013-002026-22-NL
(EUCTR)
24/10/201327/06/2013Adminstration 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
ErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
13NCT02453750
(ClinicalTrials.gov)
February 201221/5/2015Airway Inflammation in Congenital Diaphragmatic Hernia PatientsInvestigation of Airway Inflammation in Congenital Diaphragmatic Hernia PatientsCongenital Diaphragmatic HerniaDrug: Hypersaline;Drug: Bronchodilator ResponseThe Hospital for Sick ChildrenNULLCompleted6 Years18 YearsAll21N/ACanada
14NCT00226044
(ClinicalTrials.gov)
September 200522/9/2005Rectal 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, DiaphragmaticDrug: Omeprazole rectally 1mg/kgRijnstate HospitalErasmus Medical CenterCompleted6 Weeks3 MonthsAll17Phase 3Netherlands
15EUCTR2017-000421-13-NO
(EUCTR)
11/01/2018Treatment 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 MCNULLNAFemale: yes
Male: yes
330Phase 3Belgium;Austria;Netherlands;Norway
16EUCTR2017-000421-13-SE
(EUCTR)
11/09/2018Treatment 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 MCNULLNAFemale: yes
Male: yes
330Phase 3Belgium;Austria;Norway;Netherlands;Sweden