Markers of Inflammation and Lung Recovery in ECMO Patients for PPHN

NCT02940327 | Completed Results

• 1 other identifier: 0553
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Pulmonary Hypertension of the Newborn

Keywords

ECMO; PPHN; Pulmonary Hypertension of the Newborn; Markers of inflammation; Mi-Ecmo

Outcome Measures

Primary Outcomes (15)

• CD16/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  12 hours after ECMO commencement

• CD16/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  24 hours after ECMO commencement

• CD16/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  48 hours after ECMO commencement

• CD16/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  72 hours after ECMO commencement

• CD16/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  24 hours after decannulation

• CD14/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  12 hours after ECMO commencement

• CD14/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  24 hours after ECMO commencement

• CD14/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  48 hours after ECMO commencement

• CD14/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  72 hours after ECMO commencement

• CD14/41

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  24 hours after ECMO decannulation

• CD64/163

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  12 hours after ECMO commencement

• CD64/163

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  24 hours after ECMO commencement

• CD64/163

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  48 hours after ECMO commencement

• CD64/163

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  72 hours after ECMO commencement

• CD64/163

  Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.

  24 hours after decannulation

Secondary Outcomes (15)

• Change of Serum Haemoglobin Levels

  baseline

• Duration on ECMO

  > 7 days or did not survive to discharge

• Number of Participants With Acute Kidney Injury

  >7 days or did not survive to discharge

• Heart Injury as Determined by Serum Troponin Levels

  12 hours after ECMO commencement

• Allogenic Red Cell Transfusion Volume

  24 hours after ECMO is discontinued

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study will be conducted at a regional ECMO centre in the UK, the University Hospitals of Leicester NHS Trust. This unit performs over 60 neonatal and paediatric ECMO per year, of which at least 40 are expected to be performed for the treatment of PPHN in infants.

You may qualify if:

• 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

You may not qualify if:

• PPHN is caused by a congenital heart pathology
• ECMO is required for a congenital heart disease
• Lack of consent

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator
• Heart Link Children's Charity: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, LE3 9QP, United Kingdom

Location

Related Publications (58)

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  PMID: 31725531 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, Urine samples, Respiratory samples

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Clinical Trials Co-ordinator
• Organization: University of Leicester

ha200@le.ac.uk

0116 250 2427

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 20, 2016
• Study Start: February 19, 2016
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)