Persistent Fetal Circulation SyndromeNCT00371241
Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO
An observational study of Persistent Fetal Circulation Syndrome and Diaphragmatic Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Infants are placed on ECMO for correction of reversible respiratory failure. Often, because a few of the reasons for respiratory failure show us similar things in the baby, it is difficult to determine exactly which is causing the biggest problem. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Persistent Fetal Circulation Syndrome, Diaphragmatic Hernia, Meconium Aspiration
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2007
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants requiring ECMO
Who may be able to join
- 1) term newborn infants >24 hours and ≤ 30 days old 2) Placed on ECMO in the NICU at MHCH 3) Parental consent obtained within 48 hours of being placed on ECMO
Who cannot join
- 1) Infant > 30 days old 2) Infant NOT on ECMO 3) Withdrawal of parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibody Secreting Cell (ASC) and Immunoactive Protein Profiles in Neonates on Extracorporeal Membrane Oxygenation (ECMO)
Infants are placed on ECMO for correction of reversible respiratory failure. Often, because a few of the reasons for respiratory failure show us similar things in the baby, it is difficult to determine exactly which is causing the biggest problem. We are now capable of measuring certain cells and proteins in these infants that may help us more accurately diagnose the exact problem. We hypothesize that infants placed on ECMO will show unique antibody-secreting cells responses and patterns of cytokine and chemokine (protein) response to illness and to the ECMO circuit. If we find unique patterns to these cells or proteins, they may be able to predict outcomes or guide treatment of these infants.
Read the detailed description
Specific Aims Primary Objective
- Determine the rise, peak, and fall of immunoglobulin isotype-specific ASC's, and immunoactive proteins (cytokines and chemokines) from sequential samples of peripheral blood from infants on ECMO.
Secondary Objectives:
- Determine the most appropriate time to sample blood from infants with suspected sepsis for ASC diagnostic assay.
- Characterize the incidence of culture-negative sepsis that leads to ECMO.
- Determine immunoglobulin isotype-specific levels of ASC in infants with and without infection.
- Establish an archive of mononuclear cells and plasma to use in development of pathogen specific ASC assays.
Hypothesis Infants on ECMO will have a high ASC response and unique cytokine/chemokine patterns due to possible underlying infection and exposure to many foreign antigens (blood products, ECMO circuit). A significant portion of these will have ASC's with specificity for common causes of neonatal sepsis that is not detected by routine blood culture.
Procedures:
Residual samples will be collected from those used in routine procedures for infants on ECMO. The approximate volume/sample will be 0.5-0.8ml. Specimens will be processed using methods well established in our laboratory. Briefly, PBMC's will be isolated via Ficoll gradient and archived in liquid nitrogen at -80C. Batch analysis of ASC levels and lymphocyte proliferation activity will be performed when sufficient number of specimens are accumulated. A detailed profile and quantification of immune cells will be determined by Fluorescent Activated Cell Sorter (FACS) staining for CD3, CD4, CD8, CD27, CD38, CD45, and HLA-DR. A bead micro-array will be used to detect levels of immunoactive molecules, also done on the FACS. The proteins detected will include, but may not be limited to, the following: IL1β, IL2, IL4, IL5, IL6, IL7, IL8, IL10, IL12p70, IL13, IL17, GCSF, GMCSF, IFN-γ, MCP-1, MIP-1β, TNFα. The ASC procedure be that established by Van de Verg modified to use membrane surface microculture plates in place of agar with outcomes read by CTL analyzer in place of manual count. LPA assays will use long established techniques.
- Keywords
- ECMO, extracorporeal membrane oxygenation, cytokines, chemokines
- Medical subject headings
- Persistent Fetal Circulation Syndrome, Hernia, Diaphragmatic, Meconium Aspiration Syndrome, Sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startSep 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Persistent Fetal Circulation SyndromeStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Investigators
- James M Murpy, PhD, Principal investigator, University of Texas Health Science Center at Houston- Division of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371241
- Sponsor's protocol ID
- HSC-MS-06-0122
- Status last verified
- Nov 2020
- First submitted
- 30 Aug 2006
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoll BJ, Lee FK, Hale E, Schwartz D, Holmes R, Ashby R, Czerkinsky C, Nahmias AJ. Immunoglobulin secretion by the normal and the infected newborn infant. J Pediatr. 1993 May;122(5 Pt 1):780-6. doi: 10.1016/s0022-3476(06)80026-0.
PubMed 8496761Stoll BJ, Lee FK, Larsen S, Hale E, Schwartz D, Rice RJ, Ashby R, Holmes R, Nahmias AJ. Clinical and serologic evaluation of neonates for congenital syphilis: a continuing diagnostic dilemma. J Infect Dis. 1993 May;167(5):1093-9. doi: 10.1093/infdis/167.5.1093.
PubMed 8486942Baqar S, Nour El Din AA, Scott DA, Bourgeois AL, Mourad AS, Kleinosky MT, Oplinger MJ, Murphy JR. Standardization of measurement of immunoglobulin-secreting cells in human peripheral circulation. Clin Diagn Lab Immunol. 1997 May;4(3):375-9. doi: 10.1128/cdli.4.3.375-379.1997.
PubMed 9144380Kuster H, Weiss M, Willeitner AE, Detlefsen S, Jeremias I, Zbojan J, Geiger R, Lipowsky G, Simbruner G. Interleukin-1 receptor antagonist and interleukin-6 for early diagnosis of neonatal sepsis 2 days before clinical manifestation. Lancet. 1998 Oct 17;352(9136):1271-7. doi: 10.1016/S0140-6736(98)08148-3.
PubMed 9788457
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Secreting Cell (ASC) and Immunoactive Protein Profiles in Neonates on Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT00371241
- Acronym / sponsor ID
- HSC-MS-06-0122
- Keywords
- ECMO, extracorporeal membrane oxygenation, cytokines, chemokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Study start
- Sep 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 4 Sep 2006 (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.
Infants are placed on ECMO for correction of reversible respiratory failure. Often, because a few of the reasons for respiratory failure show us similar things in the baby, it is difficult to determine exactly which is causing the biggest problem. We are now capable of measuring certain cells and proteins in these infants that may help us more accurately diagnose the exact problem. We hypothesize that infants placed on ECMO will show unique antibody-secreting cells responses and patterns of cytokine and chemokine (protein) response to illness and to the ECMO circuit. If we find unique patterns to these cells or proteins, they may be able to predict outcomes or guide treatment of these infants.
Detailed description
Specific Aims Primary Objective
- Determine the rise, peak, and fall of immunoglobulin isotype-specific ASC's, and immunoactive proteins (cytokines and chemokines) from sequential samples of peripheral blood from infants on ECMO.
Secondary Objectives:
- Determine the most appropriate time to sample blood from infants with suspected sepsis for ASC diagnostic assay.
- Characterize the incidence of culture-negative sepsis that leads to ECMO.
- Determine immunoglobulin isotype-specific levels of ASC in infants with and without infection.
- Establish an archive of mononuclear cells and plasma to use in development of pathogen specific ASC assays.
Hypothesis Infants on ECMO will have a high ASC response and unique cytokine/chemokine patterns due to possible underlying infection and exposure to many foreign antigens (blood products, ECMO circuit). A significant portion of these will have ASC's with specificity for common causes of neonatal sepsis that is not detected by routine blood culture.
Procedures:
Residual samples will be collected from those used in routine procedures for infants on ECMO. The approximate volume/sample will be 0.5-0.8ml. Specimens will be processed using methods well established in our laboratory. Briefly, PBMC's will be isolated via Ficoll gradient and archived in liquid nitrogen at -80C. Batch analysis of ASC levels and lymphocyte proliferation activity will be performed when sufficient number of specimens are accumulated. A detailed profile and quantification of immune cells will be determined by Fluorescent Activated Cell Sorter (FACS) staining for CD3, CD4, CD8, CD27, CD38, CD45, and HLA-DR. A bead micro-array will be used to detect levels of immunoactive molecules, also done on the FACS. The proteins detected will include, but may not be limited to, the following: IL1β, IL2, IL4, IL5, IL6, IL7, IL8, IL10, IL12p70, IL13, IL17, GCSF, GMCSF, IFN-γ, MCP-1, MIP-1β, TNFα. The ASC procedure be that established by Van de Verg modified to use membrane surface microculture plates in place of agar with outcomes read by CTL analyzer in place of manual count. LPA assays will use long established techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants requiring ECMO
Key inclusion criteria (1 listed)
- 1) term newborn infants >24 hours and ≤ 30 days old 2) Placed on ECMO in the NICU at MHCH 3) Parental consent obtained within 48 hours of being placed on ECMO
Key exclusion criteria (1 listed)
- 1) Infant > 30 days old 2) Infant NOT on ECMO 3) Withdrawal of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 8496761Stoll BJ, Lee FK, Hale E, Schwartz D, Holmes R, Ashby R, Czerkinsky C, Nahmias AJ. Immunoglobulin secretion by the normal and the infected newborn infant. J Pediatr. 1993 May;122(5 Pt 1):780-6. doi: 10.1016/s0022-3476(06)80026-0.
- Background: PubMed 8486942Stoll BJ, Lee FK, Larsen S, Hale E, Schwartz D, Rice RJ, Ashby R, Holmes R, Nahmias AJ. Clinical and serologic evaluation of neonates for congenital syphilis: a continuing diagnostic dilemma. J Infect Dis. 1993 May;167(5):1093-9. doi: 10.1093/infdis/167.5.1093.
- Background: PubMed 9144380Baqar S, Nour El Din AA, Scott DA, Bourgeois AL, Mourad AS, Kleinosky MT, Oplinger MJ, Murphy JR. Standardization of measurement of immunoglobulin-secreting cells in human peripheral circulation. Clin Diagn Lab Immunol. 1997 May;4(3):375-9. doi: 10.1128/cdli.4.3.375-379.1997.
- Background: PubMed 9788457Kuster H, Weiss M, Willeitner AE, Detlefsen S, Jeremias I, Zbojan J, Geiger R, Lipowsky G, Simbruner G. Interleukin-1 receptor antagonist and interleukin-6 for early diagnosis of neonatal sepsis 2 days before clinical manifestation. Lancet. 1998 Oct 17;352(9136):1271-7. doi: 10.1016/S0140-6736(98)08148-3.
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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.
James M Murpy, PhD principal investigator
University of Texas Health Science Center at Houston- Division of Infectious Diseases
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 Persistent Fetal Circulation Syndrome and Diaphragmatic Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Nov 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371241, which also lists 4 linked publications.
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 5 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.