Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease

NCT04733378 | Unknown

• 2 other identifiers: 2019-442020-A00369-30
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.

Conditions

Complex Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Measurement of the association between age at surgery (days of life) and scores (mean = 100, standard deviation = 15) obtained on the Bayley II test

  Measurement of the association between age at surgery (days of life) and scores (mean = 100, standard deviation = 15) obtained on the Bayley II test for each subtest: motor, cognitive and language. This association will be evaluated by a correlation coefficient

  12 months

Study Arms (1)

Peri-operative neurological monitoring

EXPERIMENTAL

Procedure: Peri-operative neurological monitoring

Interventions

Peri-operative neurological monitoring PROCEDURE

Pre- and post-operative cerebral MRI, standardized neurological examinations at 4, 12, 24 months and neuropsychological evaluation with a Bayley III test (Bayley Scale of Infant and Toddler Development, Third Edition) at 24 months.

Peri-operative neurological monitoring

Eligibility Criteria

• Age: 0 Months - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

Study Officials

• Béatrice DESNOUS, MD

  Assistance Publique-Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie GARRIDO-PRADALIE, Reasearch Director

CONTACT

0491382747; drci@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: December 24, 2021
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)