ewborns with Congenital diaphragmatic hernia; iNO versus sildenafil

Phase 1

• Conditions: Congenital diaphragmatic hernia with pulmonary hypertension; MedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2017-000421-13-IT
• Lead Sponsor: ERASMUS MEDICAL CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-06
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

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
Number of subjects for this age range:
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
-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.

Study & Design

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