NCT02996630

Brief Summary

Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns per year. Children with CHD are a known risk population for brain injury, with neurodevelopmental alterations shown over time in up to 50% of cases. No adequate description exists of the type of neurocognitive anomalies or risk factors associated with CHD, and consequently no prognostic markers that may allow identification of high-risk cases are available.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

December 19, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

October 31, 2016

Last Update Submit

December 14, 2016

Conditions

Congenital Heart Disease

Keywords

LVOTOFallotGreat Arteries Transposition

Outcome Measures

Primary Outcomes (1)

  • Bailey-III test punctuation

    Results in pediatric Bailey-III test scale

    45 minutes

Secondary Outcomes (11)

  • Biparietal diameter (mm)

    one day

  • Lateral sulcus depth

    one day

  • Cerebral insula

    one day

  • Brain biometries

    one day

  • Cerebral cingulata sulcus

    one day

  • +6 more secondary outcomes

Study Arms (2)

Healthy fetuses

OTHER

Pregnant patients carrying a healthy fetus. Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging and bailey test.

Procedure: SonographyDevice: Magnetic Resonance ImagingOther: Bailey TestProcedure: cord blood sample

Congenital Hearth Disease

OTHER

Pregnant patients carrying a fetus with a moderate-severe congenital heart disease Interventions in this group will be: cord blood sample, sonography, Magnetic Resonance Imaging, Surgical intervention, brain monitoring and bailey test.

Procedure: SonographyDevice: Magnetic Resonance ImagingOther: Bailey TestProcedure: Surgical interventionProcedure: Brain monitoringProcedure: cord blood sample

Interventions

SonographyPROCEDURE

Fetal Ultrasound exploration

Congenital Hearth DiseaseHealthy fetuses
Magnetic Resonance ImagingDEVICE

Fetal MRI for brain study

Congenital Hearth DiseaseHealthy fetuses
Bailey TestOTHER

Neurodevelopment paediatric assessment test performed at 2 years of age.

Congenital Hearth DiseaseHealthy fetuses
Surgical interventionPROCEDURE

Congenital Heart Disease repair

Congenital Hearth Disease
Brain monitoringPROCEDURE

EEG and continuous brain oximetry before surgery.

Congenital Hearth Disease
cord blood samplePROCEDURE

Cord blood samples will be taken after birth in both groups.

Congenital Hearth DiseaseHealthy fetuses

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Single pregnancies
  • Major Congenital Heart Disease
  • Informed Consent Signed

You may not qualify if:

  • Major extra-cardiac malformations
  • Parental Refusal to participate
  • Maternal Chronic Disease
  • Multiple Pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebrón

Barcelona, Barcelona, 08035, Spain

RECRUITING

Related Publications (6)

  • Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.

    PMID: 12084585RESULT

  • Bellinger DC, Jonas RA, Rappaport LA, Wypij D, Wernovsky G, Kuban KC, Barnes PD, Holmes GL, Hickey PR, Strand RD, et al. Developmental and neurologic status of children after heart surgery with hypothermic circulatory arrest or low-flow cardiopulmonary bypass. N Engl J Med. 1995 Mar 2;332(9):549-55. doi: 10.1056/NEJM199503023320901.

    PMID: 7838188RESULT

  • Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.

    PMID: 11060529RESULT

  • Masoller N, Martinez JM, Gomez O, Bennasar M, Crispi F, Sanz-Cortes M, Egana-Ugrinovic G, Bartrons J, Puerto B, Gratacos E. Evidence of second-trimester changes in head biometry and brain perfusion in fetuses with congenital heart disease. Ultrasound Obstet Gynecol. 2014 Aug;44(2):182-7. doi: 10.1002/uog.13373. Epub 2014 Jul 8.

    PMID: 24687311RESULT

  • Ruiz A, Cruz-Lemini M, Masoller N, Sanz-Cortes M, Ferrer Q, Ribera I, Martinez JM, Crispi F, Arevalo S, Gomez O, Perez-Hoyos S, Carreras E, Gratacos E, Llurba E. Longitudinal changes in fetal biometry and cerebroplacental hemodynamics in fetuses with congenital heart disease. Ultrasound Obstet Gynecol. 2017 Mar;49(3):379-386. doi: 10.1002/uog.15970.

    PMID: 27214694RESULT

  • Ribera I, Ruiz A, Sanchez O, Eixarch E, Antolin E, Gomez-Montes E, Perez-Cruz M, Cruz-Lemini M, Sanz-Cortes M, Arevalo S, Ferrer Q, Vazquez E, Vega L, Dolader P, Montoliu A, Boix H, Simoes RV, Masoller N, Sanchez-de-Toledo J, Comas M, Bartha JM, Galindo A, Martinez JM, Gomez-Roig L, Crispi F, Gomez O, Carreras E, Cabero L, Gratacos E, Llurba E. Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol. BMC Pediatr. 2019 Sep 10;19(1):326. doi: 10.1186/s12887-019-1689-y.

    PMID: 31506079DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalTransposition of Great Vessels

Interventions

High-Energy Shock WavesMagnetic Resonance ImagingSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Elisa Llurba, MD, PhD

    Hospital Universitari Vall d'Hebrón

    STUDY DIRECTOR

Central Study Contacts

Irene Ribera, MD

CONTACT

934893000irene.ribera@vhir.org

Aina Ruiz, MD

CONTACT

934893000aruizrom@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

December 19, 2016

Study Start

May 1, 2013

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

December 19, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)