Examining how the timing of surgery affects brain development in newborns with complex heart defects
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
NA · Assistance Publique Hopitaux De Marseille · NCT04733378
This study is trying to see if doing heart surgery earlier on newborns with complex heart defects can help their brain development and reduce complications after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Months to 2 Months |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille) |
| Trial ID | NCT04733378 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between the age at which newborns with complex congenital heart disease (CCHD) undergo surgery and their neurodevelopmental outcomes. It will assess whether earlier surgical intervention can reduce the incidence of white matter injuries observed through MRI and decrease postoperative complications. The study will also evaluate the length of hospital stays for these patients. By understanding these associations, the research seeks to identify potential neuroprotective strategies for infants with CCHD.
Who should consider this trial
Good fit: Ideal candidates are newborns aged 2 months or less with complex congenital heart disease requiring surgery within their first 2 months of life.
Not a fit: Patients with a birth weight less than 2 kilograms or those with chromosomal abnormalities associated with CCHD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neurodevelopmental outcomes for infants with complex congenital heart disease.
How similar studies have performed: While the approach of examining surgical timing in relation to neurodevelopmental outcomes is being explored, the specific focus on CCHD and its neuroprotective strategies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Patients aged 2 months or less with complex congenital heart disease (CCHD) requiring surgery with cardiac circulation during their first 2 months of life * Eligible heart diseases: Transposition of the Large Vessels (TGV), hypoplasia of the left ventricle, right ventricle with double outlet type Fallot or TGV, obstruction of the aortic arch, truncus arteriosus, atrioventricular duct, pulmonary atresia with or without communication inter ventricular. * Informed consent signed by both parents * Patient affiliated to health social security Non-inclusion criteria: * patients with a birth weight less than 2 kilograms and / or a gestational age less than 37 weeks * patients with a CCHD not requiring cardiac surgery with extra-corporeal circulation in the first 2 months of life * patients with a chromosomal abnormality or genetic syndrome proven associated with CCHD
Where this trial is running
Marseille
- Assistance Publique Des Hopitaux de Marseille — Marseille, France (RECRUITING)
Study contacts
- Principal investigator: Béatrice DESNOUS, MD — Assistance Publique-Hôpitaux de Marseille
- Study coordinator: Emilie GARRIDO-PRADALIE, Reasearch Director
- Email: drci@ap-hm.fr
- Phone: 0491382747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Complex Congenital Heart Disease