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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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
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
  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6500 HB

    V Christmann, MD, 0031243613936, v.christmann@cukz.umcn.nl

    R. de Groot, prof. dr.

    Recruiting

Other trials in Netherlands

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 groups in NCT00622492
Study groupRoleWhat they receive
VV-ECMOnewborn infants with reversible causes of PPHN eligible for ECMO treatment
Receives: Other: echocardiography Doppler sonography, blood and urine sampling
VA-ECMOnewborn 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.

  1. First posted25 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2010 (estimated)
  4. Study completionOct 2010 (estimated)

Resources

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)
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

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