Neonatal Congenital Heart Disease Clinical Trial
— CHD BrainOfficial title:
Role of Inflammatory Response in Brain Injury Following Neonatal Cardiac Surgery
| Verified date | February 2016 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 92 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 30 Days |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University | Children's Healthcare of Atlanta |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary outcome will be a measure of the association of pro-inflammatory cytokines with WMI score | 5 years | No | |
| Secondary | Association between inflammatory response and neurodevelopmental testing | 5 years | No | |
| Secondary | Association of neuroimaging abnormalities with neurodevelopmental testing | 5 years | No |