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van CCT (UK)

van CCT (UK)

Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide or intravenous Sildenafil for pulmonary hypertension

- candidate number28510
- NTR NumberNTR6982
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2018
- Secondary IDsNL60229.078.17 
- Public TitleNewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide or intravenous Sildenafil for pulmonary hypertension
- Scientific TitleNewborns with Congenital Diaphragmatic hernia:
inhaled Nitric Oxide versus intravenous
an international randomized controlled trial
- hypothesisIV sildenafil is superior to iNO for the treatment of pulmonary hypertension in CDH newborns and should be considered as the drug of first choice in the future
- Healt Condition(s) or Problem(s) studiedCongenital diaphragmatic hernia, Pulmonary arterial hypertension (PAH), Infant-newborn
- Inclusion criteriaDiagnosis 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.
Parental informed consent
Children born at or after a gestational age of 34 weeks
Newborns who received a fetal intervention may be included
- Exclusion criteriaSevere 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate1-feb-2022
- Target number of participants330
- InterventionsSildenafil with be given intravenously, using a loading dose of 0.4mg/kg in 3 hours, followed by continuous infusion of 1.6mg/kg/day Inhaled NO will be given with a starting dose of 20 ppm, which is the maximum dose
- Primary outcomeThe absence of pulmonary hypertension on echocardiography on day 14 without pulmonary vasodilator therapy and without treatment failure in patients and/or death within the first 28 days of life
- Secondary outcome Oxygenation index
Overall mortality
Incidence of treatment failure
Time on intervention drug (intervention drug free days on day 14)
Vasoactive-inotropic support score
Need for ECMO
Ventilator free days on day 28
Severity of pulmonary hypertension, using laboratory markers and tracheal aspirates for proteomic, metabolomics and biochemical analysis as a marker
The use of other medication given for pulmonary hypertension during the hospital admission
The use of pulmonary and/or cardiac medication at discharge and its total duration
Long-term pulmonary hypertension on echocardiography at 6 and 12 months
Chronic lung disease
The development of neurological abnormalities evaluated with ultrasound of the brain
External validation of sildenafil PKPD model
- TimepointsRandomization period, within the first 7 days of life
Treatment period, from randomization until day 14
Observation period, from day 14 until 12 months after birth
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD candidate S.C.M. Cochius - den Otter
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Stichting Sophia Kinderziekenhuis Fonds, CDH UK the congenital diaphragmatic hernia charity
- Publications
- Brief summaryInfants with CDH will be randomized to receive either iNO or intravenous sildenafil if clinical significant PH is present. The patient can participate in the trial within the first seven days of life. Inhaled NO will be given with a starting dose of 20 ppm. Inhaled nitric oxide will be provided by a tank connected to a neonatal ventilator. Therefore, the study will be open label. Sildenafil with be given intravenously, using a loading dose of 0.4mg/kg in 3 hours, followed by continuous infusion of 1.6mg/kg/day.
The patients will be treated according to the standard protocol for patients with CDH, which is implemented in all participating centers according to the revised CDH consortium guidelines. Strict guidelines for cardiovascular support will be used.
Echocardiography will be performed to determine eligibility of entry into the study at day 1,and subsequently before study drug administration, on day 14, day 28 (or discharge whichever is sooner) and at follow up at 6 and 12 months. The echocardiographic images will be collected for centralized, blinded analysis of pulmonary artery pressure and cardiac function by 2 investigators. Demographic and neonatal characteristics as well as data on the clinical course and treatment of all patients will be collected in a central database in Rotterdam.
Because all patients will be analyzed on the basis of intention-to-treat, data after treatment failure will be collected in a similar way for all included patients.
- Main changes (audit trail)
- RECORD29-jan-2018 - 2-feb-2018

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