Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease (CHD Brain)
Role of Inflammatory Response in Brain Injury Following Neonatal Cardiac Surgery
Infants with congenital heart disease (CHD) requiring surgery frequently have brain injury seen on magnetic resonance imaging (MRI). This occurs in approximately 40% of these newborns, and even though these are full-term infants, the injury seen closely resembles the same form of brain injury that can be seen in premature babies. Much like premature newborns, infants with CHD also have long-term neurodevelopmental problems (in over 50%).
The investigators do not know why infants with CHD get this specific form of brain injury. One risk factor is felt to be the inflammation that occurs in response to heart-lung bypass (cardiopulmonary bypass, or CPB), a necessary feature of open-heart surgery. Newborns have a stronger inflammatory reaction to CPB than older children or adults. The investigators do know from animal experiments and other human data that inflammation can be harmful to the developing brain.
The investigators hypothesize that children with CHD requiring surgery as a newborn have brain injury due to toxicity from the inflammatory response. The investigators will test this by enrolling newborns undergoing heart surgery to measure markers of inflammation, measure brain injury by MRI, and then test their developmental outcome at 1 and 2 years of age.
An association between inflammation and injury might impact what medicines are chosen to protect the brain in future studies, even in other populations such as preterm infants.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Children's Healthcare of Atlanta
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Term or near-term (> 35 week gestation) neonates with CHD presenting for cardiac surgery
- Less than 30 days old
- No patient will be excluded because of race or ethnicity
- Parental or legal guardian consent will be obtained for all patients prior to enrollment
Exclusion Criteria:
- Newborns with multiple organ abnormalities in addition to their heart defect such as diaphragmatic hernia, tracheo-esophageal fistula, and congenital syndromes will be excluded from participation
- Newborns with either genetic syndromes or congenital infections that are associated with developmental delay will also be excluded
- Newborns with perinatal depression as defined by a cord blood gas pH < 7.0 or a 5 minute Apgar score < 5, will be excluded
- Patients with multiple organ failure, syndromes, and perinatal depression have other causes for neurodevelopmental abnormalities
- Those patients unable to return for postoperative follow-up and neurodevelopmental testing will also be excluded from participation
- Parent or legal guardian unable or unwilling to consent
- Non-English speaking families
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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The primary outcome will be a measure of the association of pro-inflammatory cytokines with WMI score
Zeitfenster: 5 years
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5 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Association between inflammatory response and neurodevelopmental testing
Zeitfenster: 5 years
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5 years
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Association of neuroimaging abnormalities with neurodevelopmental testing
Zeitfenster: 5 years
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5 years
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: William T Mahle, MD, Emory University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB00017965
- 17965 (Andere Kennung: Other)
Plan für individuelle Teilnehmerdaten (IPD)
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