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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00622492 |
Rationale: Persistent pulmonary hypertension of the newborn (PPHN) is a life threatening disease with a high mortality rate. Extracorporeal Membrane Oxygenation (ECMO) with veno-arterial (V-A) or veno-venous (V-V) cannulation can provide a last treatment option. Differences in circulatory changes between V-A and V-V ECMO concerning the course of PPHN and organ perfusion are not known. Independent of the underlying disease, courses of ECMO runs (with both systems) may differ a lot. Impairment of pulmonary and renal function and oedema is frequently seen. Mechanisms that may play a role are not well understood yet. A better understanding of hemodynamic changes in systemic and pulmonary circulation during treatment of PPHN with ECMO as well as consecutive changes in organ perfusion and function will help to develop more rationalistic treatment strategies to accelerate the recovery to a normal neonatal circulation and shorten ECMO treatment. This will reveal positive effects for patients as well as favourable effects on economic aspects for this very intensive treatment.
Primary objective: I.Evaluation of changes in pulmonary and systemic circulation during VV- ECMO treatment and difference between V-V- and V-A ECMO Secondary objectives:II.Evaluation of changes in cerebral, renal and mesenterial organ perfusion during ECMO treatment and difference between V-V- and V-A ECMO III.Evaluation of hemodynamic changes during ECMO treatment in relation to renal function and difference between V-V- and V-A ECMO IV.Evaluation of BNP as diagnostic parameter regarding fluid homeostasis during ECMO treatment and difference between V-V- and V-A ECMO Study design: observational; including two cohorts. The first cohort consists of a group of patients that have been evaluated in a former study, exclusively treated with V-A ECMO. The second cohort of patients will prospectively include patients receiving V-V as well as V-A ECMO. A study period:2 and a half years. All consecutively admitted patients for ECMO treatment at the department of neonatology of the RUNMC will be evaluated for inclusion into the study. Study population: Inclusion: Newborn infants with gestational age older than 34 weeks and reversible causes of PPHN eligible for ECMO treatment. Exclusion:Newborn infants with congenital diaphragmatic hernia, other congenital malformations and post-cardiosurgery.
Intervention: Standard treatment following the ECMO protocol of the department; evaluation at standard intervals starting directly before cannulation for ECMO until 24 hours after decannulation:registration of hemodynamic variables,parameters for organ perfusion using echocardiography and Doppler sonography, blood and urine sampling and registration of physiological and patient data.
Main study parameters/endpoints: Assessment of:Hemodynamic changes in pulmonary and systemic circulation Secondary and other parameters/endpoints:
Assessment of:Changes in cerebral, renal and mesenterial blood flow, renal function in relation hemodynamic changes,BNP in relation to fluid homeostasis
Condition | Intervention |
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Pulmonary Hypertension of the Newborn (PPHN) |
Other: echocardiography Doppler sonography, blood and urine sampling |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | ECMO in Newborn Infants: Circulatory Changes in Relation to Venovenous and Venoarterial Bypass. Implications for Peripheral Organ Circulation |
whole blood, urine
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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VV-ECMO
newborn infants with reversible causes of PPHN eligible for ECMO treatment
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Other: echocardiography Doppler sonography, blood and urine sampling
data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO
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VA-ECMO
newborn infants with reversible causes of PPHN eligible for ECMO treatment
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Other: echocardiography Doppler sonography, blood and urine sampling
data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
newborn infants with PPHN admitted to the NICU Radboud University Medical Centre for ECMO treatment consecutive patient sampling
Inclusion Criteria:
Exclusion Criteria:
Contact: V Christmann, MD | 0031243613936 | v.christmann@cukz.umcn.nl |
Netherlands | |
Radboud University Nijmegen Medical Centre | Recruiting |
Nijmegen, Netherlands, 6500 HB | |
Contact: V Christmann, MD 0031243613936 v.christmann@cukz.umcn.nl | |
Principal Investigator: R. de Groot, prof. dr. |
Responsible Party: | Radboud University Nijmegen Medical Centre ( V. Christmann ) |
Study ID Numbers: | 2007/219 |
Study First Received: | January 30, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622492 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
VV-ECMO VA-ECMO PPHN organ circulation |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Vascular Diseases Hypertension |
Cardiovascular Diseases |