NCT00371241

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

First QC Date

August 30, 2006

Last Update Submit

November 3, 2020

Conditions

Keywords

ECMOextracorporeal membrane oxygenationcytokineschemokines

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants requiring ECMO

You may qualify if:

  • \) 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

You may not qualify if:

  • \) Infant \> 30 days old 2) Infant NOT on ECMO 3) Withdrawal of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • 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.

    PMID: 8496761BACKGROUND
  • Stoll 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.

    PMID: 8486942BACKGROUND
  • Baqar 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.

    PMID: 9144380BACKGROUND
  • Kuster 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.

    PMID: 9788457BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and whole blood

MeSH Terms

Conditions

Persistent Fetal Circulation SyndromeHernia, DiaphragmaticMeconium Aspiration SyndromeSepsis

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsLung InjuryRespiration DisordersFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Officials

  • James M Murpy, PhD

    University of Texas Health Science Center at Houston- Division of Infectious Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 4, 2006

Study Start

September 1, 2006

Study Completion

November 1, 2007

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations