Predictors of Sepsis in Ex-Preterm Infants
The aims of this study are to:
- Assess whether ex-preterm infants have a persistently immature immune system, which may decrease their ability to respond to infections, when they reach term-corrected gestational age.
- Examine whether clinical history, nutrition status, and microbiome composition are linked to the immune composition of term and ex-preterm infants and whether these variables can be used to predict the risk of developing sepsis or having an immunologic disease.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Preterm infants have increased numbers of viral infections in childhood. They are also more likely to die from infection during the neonatal and infant periods than infants born at term. While studies have demonstrated that premature infants have decreased adaptive and innate immune responses compared with infants born at term, there has been little investigation into whether this impaired immunity improves and becomes similar to full term infants once the ex-preterm infants reach term-corrected gestational age. There have likewise not been studies to determine whether specific immune markers may predict the risk of developing sepsis. Given the immaturity of the preterm immune system and the many potential infectious and inflammatory insults they are exposed to during the preterm period (infections, poor nutrition, stress, steroid therapy), there is also a possibility that the relative immune deficiency experienced by preterm infants may persist into infancy.
The goal of this study is to determine whether former preterm infants have sustained differences in immunity compared to age-matched controls, which would have significant implications for infection risk and response to vaccination. Additionally, this study hopes to examine whether certain immune system abnormalities make certain babies more likely to have a serious infection. The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02115
- Boston Children's Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria Ex-Preterm Infant Group:
- Infants born less than 37 weeks gestational age
Exclusion Criteria for Ex-Preterm Infant Group:
- Infants born greater than 37 weeks gestational age
Inclusion Criteria for Term Infant Group:
- Infants born greater than 37 weeks gestational age
Exclusion Criteria for Term Infant Group:
- Infants born less than 37 weeks gestational age
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Preterm Infants
Blood samples will be obtained from preterm and former preterm infants at birth and then monthly until hospital discharge.
The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen.
If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.
|
|
Term Infants
Blood samples will be obtained from term control infants admitted to the NICU monthly until hospital discharge.
The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen.
If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term.
Tijdsspanne: Up to 1 year
|
The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants.
Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.
|
Up to 1 year
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Determining whether non-modifiable variables of nutrition status, microbiome composition, or immune repertoire composition predict risk of developing infection during the hospitalization.
Tijdsspanne: Up to 1 year
|
The investigators will measure nutritional status.
Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.
|
Up to 1 year
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Amy O'Connell, MD, Boston Children's Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-P00023454
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Sepsis
-
University of California, San FranciscoNational Cancer Institute (NCI)WervingSepsis | Sepsis, ernstig | Sepsis en septische shock | Sepsis op de Intensive Care | Sepsis, septische shock | Sepsis, ernstige sepsis en septische shock | Sepsis met meervoudige orgaandisfunctie (MOD) | Sepsis met acute orgaandisfunctieVerenigde Staten
-
Assiut UniversityNog niet aan het wervenDoor sepsis geïnduceerde myocarddisfunctie | Sepsis geïnduceerde cardiomyopathieEgypte
-
University of Kansas Medical CenterUniversity of KansasWervingSepsis | Septische shock | Sepsis-syndroom | Sepsis, ernstig | Sepsis Bacterieel | Sepsis-bacteriëmieVerenigde Staten
-
Jip GroenInBiomeWervingMicrobiële kolonisatie | Neonatale infectie | Neonatale sepsis, vroege aanvang | Microbiële ziekte | Klinische sepsis | Kweeknegatieve neonatale sepsis | Neonatale sepsis, late aanvang | Kweek positieve neonatale sepsisNederland
-
The University of QueenslandRoyal Brisbane and Women's HospitalOnbekend
-
Karolinska InstitutetÖrebro University, SwedenVoltooidSepsis | Sepsis-syndroom | Sepsis, ernstigZweden
-
Ohio State UniversityVoltooidSepsis, ernstige sepsis en septische shockVerenigde Staten
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsVoltooidSepsis | Septische shock | Ernstige sepsis | Sepsis-syndroomVerenigd Koninkrijk
-
Indonesia UniversityVoltooidErnstige sepsis met septische shock | Ernstige sepsis zonder septische shockIndonesië
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityAanmelden op uitnodigingErnstige sepsis | Ernstige sepsis zonder septische shockVerenigde Staten