Pulmonary Hypertension of the Newborn (PPHN)ECMONCT00622492
Circulatory Changes During Venovenous (VV)- and Venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO)
An observational study of Pulmonary Hypertension of the Newborn (PPHN), run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension of the Newborn (PPHN)
- What is being tested?
- echocardiography Doppler sonography, blood and urine sampling
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to Oct 2010
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: newborn infants with PPHN admitted to the NICU Radboud University Medical Centre for ECMO treatment consecutive patient sampling
Who may be able to join
- Reversible cause of PPHN
- Newborn infant
- Older 34 weeks gestational age
Who cannot join
- Congenital diaphragmatic hernia
- Congenital malformation
- Post-cardiosurgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
V Christmann, MD, 0031243613936, v.christmann@cukz.umcn.nl
R. de Groot, prof. dr.
About this study
Official title: ECMO in Newborn Infants: Circulatory Changes in Relation to Venovenous and Venoarterial Bypass. Implications for Peripheral Organ Circulation
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.
Read more
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
- Being tested
- echocardiography Doppler sonography, blood and urine sampling
- Keywords
- VV-ECMO, VA-ECMO, PPHN, organ circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography Doppler sonography, blood and urine samplingOther
data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO
| Study group | Role | What they receive |
|---|---|---|
| VV-ECMO | newborn infants with reversible causes of PPHN eligible for ECMO treatment Receives: Other: echocardiography Doppler sonography, blood and urine sampling | |
| VA-ECMO | newborn infants with reversible causes of PPHN eligible for ECMO treatment Receives: Other: echocardiography Doppler sonography, blood and urine sampling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Hypertension of the Newborn (PPHN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622492
- Sponsor's protocol ID
- 2007/219
- Acronym
- ECMO
- Status last verified
- Feb 2008
- First submitted
- 30 Jan 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
Publications
Tanke RB, Daniels O, van Lier HJ, van Heyst AF, Festen C. Neonatal pulmonary hypertension during extracorporeal membrane oxygenation. Cardiol Young. 2000 Mar;10(2):130-9. doi: 10.1017/s1047951100006594.
PubMed 10817297