Pulmonary Hypertension Clinical Trial
Official title:
Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial
Pulmonary hypertension is a major determinant of postnatal survival in infants with a congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation period in infants born with this rare birth defect might contribute to the development of pulmonary hypertension after birth - in particular umbilical cord clamping before lung aeration. An ovine model of diaphragmatic hernia demonstrated that cord clamping after lung aeration, called physiological-based cord clamping (PBCC), avoided the initial high pressures in the lung vasculature while maintaining adequate blood flow, thereby avoiding vascular remodelling and aggravation of pulmonary hypertension. The investigators aim to investigate if the implementation of PBCC in the perinatal stabilisation period of infants born with a CDH could reduce the incidence of pulmonary hypertension in the first 24 hours after birth. The investigators will perform a multicentre, randomised controlled trial in infants with an isolated CDH. Before birth, infants will be randomised to either PBCC or immediate cord clamping, stratified by treatment centre and severity of pulmonary hypoplasia on antenatal ultrasound. For performing PBCC a purpose-designed resuscitation module (the Concord Birth Trolley) will be used.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01950585 -
Hydroxyurea in Pulmonary Arterial Hypertension
|
Early Phase 1 | |
| Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
| Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
| Recruiting |
NCT04554160 -
Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
|
||
| Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
| Completed |
NCT01894035 -
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
|
||
| Not yet recruiting |
NCT04083729 -
Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
|
N/A | |
| Terminated |
NCT02243111 -
Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound
|
N/A | |
| Completed |
NCT02821156 -
Study on the Use of Inhaled NO (iNO)
|
N/A | |
| Completed |
NCT02216279 -
Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension
|
Phase 2 | |
| Terminated |
NCT02246348 -
Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)
|
N/A | |
| Recruiting |
NCT01913847 -
Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension
|
Phase 3 | |
| Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
| Completed |
NCT06240871 -
Contrast Enhanced PA Pressure Measurements
|
||
| Completed |
NCT02377934 -
Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
|
||
| Recruiting |
NCT01091012 -
Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension
|
Phase 3 | |
| Completed |
NCT00739375 -
The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension.
|
Phase 1 | |
| Completed |
NCT01463514 -
Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension
|
N/A | |
| Completed |
NCT01484899 -
Smoking: a Risk Factor for Pulmonary Arterial Hypertension?
|
N/A | |
| Completed |
NCT02275793 -
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
|