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N/A N=24

Markers of Inflammation and Lung Recovery in ECMO Patients for PPHN

Persistent Pulmonary Hypertension of the Newborn

Enrolled (actual)
24
Serious AEs
12.5%
Results posted
Mar 2020
Primary outcome: Primary: CD16/41 — 1.90; 1.13 percent change

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Pediatric
Sex
All
Sponsor
University of Leicester
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
CD16/41
1.56; 0.6
PRIMARY
CD16/41
1.56; 0.6
PRIMARY
CD16/41
1.56; 0.6
PRIMARY
CD16/41
1.56; 0.6
PRIMARY
CD16/41
1.56; 0.6
PRIMARY
CD14/41
1.01; 0.40
PRIMARY
CD14/41
1.01; 0.40
PRIMARY
CD14/41
1.01; 0.40
PRIMARY
CD14/41
1.01; 0.40
PRIMARY
CD14/41
1.01; 0.40
PRIMARY
CD64/163
3.2; 2.27
PRIMARY
CD64/163
3.2; 2.27
PRIMARY
CD64/163
3.2; 2.27
PRIMARY
CD64/163
3.2; 2.27
PRIMARY
CD64/163
3.2; 2.27
SECONDARY
Change of Serum Haemoglobin Levels
109.25; 110.23
SECONDARY
Duration on ECMO
292; 80
SECONDARY
Number of Participants With Acute Kidney Injury
3; 0
SECONDARY
Heart Injury as Determined by Serum Troponin Levels
9.54; 7.44
SECONDARY
Allogenic Red Cell Transfusion Volume
289.6; 479.2
SECONDARY
Number of Participants Requiring Non Red Cell Transfusion
10; 10
SECONDARY
Heart Injury as Determined by Serum Troponin Levels
9.54; 7.44
SECONDARY
Heart Injury as Determined by Serum Troponin Levels
9.54; 7.44
SECONDARY
Heart Injury as Determined by Serum Troponin Levels
9.54; 7.44
SECONDARY
Heart Injury as Determined by Serum Troponin Levels
9.54; 7.44
SECONDARY
Change of Serum Haemoglobin Levels
109.25; 110.23
SECONDARY
Change of Serum Haemoglobin Levels
109.25; 110.23
SECONDARY
Change of Serum Haemoglobin Levels
109.25; 110.23
SECONDARY
Change of Serum Haemoglobin Levels
109.25; 110.23
SECONDARY
Change of Serum Haemoglobin Levels
109.25; 110.23

Summary

Respiratory failure in newborns is common and has high rates of death. Where conventional intensive care strategies have failed, newborn children are referred to treatment with Extra- Corporeal Membrane Oxygenation (ECMO). This involves connecting children via large bore cannulas placed in their heart and major blood vessels to an artificial lung that adds oxygen to their blood and removes waste gases (carbon dioxide). Although this treatment saves lives, it still has some limitations. In particular, severe complications like bleeding, or damage to the kidneys can occur. These complications can lead to death in some cases and long-term disability in others. Based on ongoing research in adults and children undergoing cardiac surgery the investigators have identified a new process that may underlie some of the complications observed in ECMO. The investigators have noted that when transfused blood is infused in an ECMO circuit, this results in the accelerated release of substances from the donor cells that cause organ damage; at least in adults. There are treatments that can reverse this process. Before the investigators explore whether these treatments should be used in newborn children on ECMO, the investigators must first demonstrate that they can measure the complex inflammatory processes that occur in these critically ill children. The investigators therefore propose to conduct a feasibility study to identify the practical issues and challenges that would need to be overcome in order to perform a successful trial in this high-risk population.

Eligibility Criteria

Inclusion Criteria

  • Patients with a diagnosis of PPHN
  • Patients that require ECMO support as determined by the ECMO team
  • Patients aged less than 30 days
  • Emergency consent obtained within 12 hours from cannulation, and ultimately full consent

Exclusion Criteria

  • PPHN is caused by a congenital heart pathology
  • ECMO is required for a congenital heart disease
  • Lack of consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02940327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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