EUCTR2017-000421-13-NL
Active, not recruiting
Phase 1
ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxideversus intravenous Sildenafil:an international randomized controlled trial - CoDiNOS trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Congenital diaphragmatic hernia with pulmonary hypertension
- Sponsor
- Erasmus MC
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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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