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Clinical Trials/NL-OMON28811
NL-OMON28811
Completed
Phase 4

ewborns with congenital diaphragmatic hernia: inhaled nitric oxide versus intravenous sildenafil: an international randomized controlled trial

Erasmus MC0 sites330 target enrollmentTBD
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Conditions<p>congenital diaphragmatic hernia pulmonary hypertension newborn congenitale hernia diafragmatica pulmonale hypertensie pasgeborenen</p>CDH10028971

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
<p>congenital diaphragmatic hernia pulmonary hypertension newborn congenitale hernia diafragmatica pulmonale hypertensie pasgeborenen</p>
Sponsor
Erasmus MC
Enrollment
330
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Erasmus MC

Eligibility Criteria

Inclusion Criteria

  • •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

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)

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 3
ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: ;an international randomized controlled trial
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ewborns with Congenital diaphragmatic hernia; iNO versus sildenafil
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