Portal de investigación
The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia
Fecha de publicación:
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Cochius-den Otter, S
- Schaible, T
- Greenough, A
- van Heijst, A
- Patel, N
- Allegaert, K
- van Rosmalen, J
- Tibboel, D
- Kipfmueller, F
- Elorza, MD
- Sanchez, A
- Martinez, L
- Labrandero, C
- Arreo, V
- Cortada, P
- Caba, JC
- Capolupo, I
- Bagolan, P
- Ciralli, F
- Raffaeli, G
- Cavallaro, G
- Condo, V
- Losty, PD
- Horan, M
- Subhedar, NV
- Singh, Y
- Williams, EE
- Dassios, T
- Bhat, R
- Brandt, JB
- Kreissl, A
- Berger, A
- Urlesberger, B
- Burgos, CM
- Frenckner, B
- Larrson, B
- Pinto, C
- Saldaha, J
- Debeer, A
- Smits, A
- Emblem, R
- Keijzer, R
- Elsayed, Y
- Tingay, D
- Kraemer, U
- CDH EURO Consortium
Grupos
Abstract
Introduction Congenital diaphragmatic hernia (CDH) is a developmental defect of the diaphragm that impairs normal lung development, causing pulmonary hypertension (PH). PH in CDH newborns is the main determinant for morbidity and mortality. Different therapies are still mainly based on 'trial and error'. Inhaled nitric oxide (iNO) is often the drug of first choice. However, iNO does not seem to improve mortality. Intravenous sildenafil has reduced mortality in newborns with PH without CDH, but prospective data in CDH patients are lacking. Methods and analysis In an open label, multicentre, international randomised controlled trial in Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018-2022). Patients are randomised for intravenous sildenafil or iNO. Sildenafil is given in a loading dose of 0.4 mg/kg in 3 hours; followed by continuous infusion of 1.6mg/kg/day, iNO is dosed at 20 ppm. Primary outcome is absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life. Secondary outcome measures include clinical and echocardiographic markers of PH in the first year of life. We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed. An intention-to-treat analysis will be performed. A p-value (two-sided) <0.05 is considered significant in all analyses.
Datos de la publicación
- ISSN/ISSNe:
- 2044-6055, 2044-6055
- Tipo:
- Article
- Páginas:
- -
- PubMed:
- 31694851
- Factor de Impacto:
- 1,247 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
BMJ Open BMJ PUBLISHING GROUP
Citas Recibidas en Web of Science: 39
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