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
- Are there results?
- None posted in the registry
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.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECMO in Newborn Infants: Circulatory Changes in Relation to Venovenous and Venoarterial Bypass. Implications for Peripheral Organ Circulation
- ClinicalTrials.gov ID
- NCT00622492
- Acronym / sponsor ID
- ECMO / 2007/219
- Keywords
- VV-ECMO, VA-ECMO, PPHN, organ circulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VV-ECMO | – | Other: echocardiography Doppler sonography, blood and urine samplingnewborn infants with reversible causes of PPHN eligible for ECMO treatment |
| VA-ECMO | – | Other: echocardiography Doppler sonography, blood and urine samplingnewborn infants with reversible causes of PPHN eligible for ECMO treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- newborn infants with PPHN admitted to the NICU Radboud University Medical Centre for ECMO treatment consecutive patient sampling
Key inclusion criteria (3 listed)
- Reversible cause of PPHN
- Newborn infant
- Older 34 weeks gestational age
Key exclusion criteria (3 listed)
- Congenital diaphragmatic hernia
- Congenital malformation
- Post-cardiosurgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiography Doppler sonography, blood and urine samplingdata registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO | Other | VA-ECMO, VV-ECMO |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
- Background: PubMed 10817297Tanke 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.
Related trials for Pulmonary Hypertension of the Newborn (PPHN)
Not yet recruitingObservational study
Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension
Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
Not yet recruitingObservational study
Predictors of Outcomes in Pulmonary Hypertension of the Newborn
Hypertension, Pulmonary, Infant, Newborn, Diseases
RecruitingPhase 4
Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
Hypotension and Shock, Pulmonary Hypertension of the Newborn (PPHN)
Recruiting
Close Loop Smart Weaning for INO With PPHN
Persistent Pulmonary Hypertension of the Newborn, Inhaled Nitric Oxide
Active, not recruiting
Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension
Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension of the Newborn (PPHN), run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact V Christmann, MD (0031243613936, v.christmann@cukz.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2008.