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Clinical Trials/EUCTR2017-000421-13-IT
EUCTR2017-000421-13-IT
Active, not recruiting
Phase 1

ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS Trial

ERASMUS MEDICAL CENTER0 sites330 target enrollmentOctober 6, 2020
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DrugsREVATIO - 0.8 MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 1 FLACONCINO DA 20 MLINALOSSIN - 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO BOMBOLA IN ALLUMINIO CON VALVOLA VI DA 20 LITRI

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ERASMUS MEDICAL CENTER
Enrollment
330
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 6, 2020
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •In order to be eligible to participate in this study, a subject must meet all of the following criteria in the first week of life:
  • •1\) 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
  • •II. RV dilatation/septal displacement, RV dysfunction \+/\- LV dysfunction
  • •III. Pre\-post ductal SpO2 difference \> 10%
  • •IV. OI\>20\.
  • •2\) Parental informed consent
  • •3\) Children born at or after a gestational age of 34 weeks
  • •4\) Newborns who received a foetal intervention may be included
  • •Are the trial subjects under 18? yes

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
  • •\-Patients born in another centre, transported with iNO
  • •\-Exclusion criteria as defined in paragraph 4\.3 of the SPC of sildenafil and paragraph 4\.3 of iNO. For infants the relevant exclusion criteria are severe hepatic failure, allergy for components of the elements used in sildenafil, the use of strong CYP3A4\-inhibitors such as intraconazol and the presence of a severe intracardiac shunt.

Outcomes

Primary Outcomes

Not specified

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