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

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

Erasmus MC0 sites330 target enrollmentSeptember 11, 2018
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ConditionsCongenital diaphragmatic hernia with pulmonary hypertensionTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Drugsrevatio 0.8mg/ml solution for injectionINOmax 800ppm mol/mol inhalatiegas

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Congenital diaphragmatic hernia with pulmonary hypertension
Sponsor
Erasmus MC
Enrollment
330
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 11, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Erasmus MC

Eligibility Criteria

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
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 330

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

Outcomes

Primary Outcomes

Not specified

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