Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.

Phase 1

• Conditions: Congenital diaphragmatic hernia with pulmonary hypertension; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2017-000421-13-AT
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-08
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

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
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified