Dataset Information

Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol.

ABSTRACT:

Background

Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns. While advances in early diagnosis and postnatal management have increased survival in CHD children, worrying long-term outcomes, particularly neurodevelopmental disability, have emerged as a key prognostic factor in the counseling of these pregnancies.

Methods

Eligible participants are women presenting at 20 to < 37 weeks of gestation carrying a fetus with CHD. Maternal/neonatal recordings are performed at regular intervals, from the fetal period to 24 months of age, and include: placental and fetal hemodynamics, fetal brain magnetic resonance imaging (MRI), functional echocardiography, cerebral oxymetry, electroencephalography and serum neurological and cardiac biomarkers. Neurodevelopmental assessment is planned at 12 months of age using the ages and stages questionnaire (ASQ) and at 24 months of age with the Bayley-III test. Target recruitment is at least 150 cases classified in three groups according to three main severe CHD groups: transposition of great arteries (TGA), Tetralogy of Fallot (TOF) and Left Ventricular Outflow Tract Obstruction (LVOTO).

Discussion

The results of NEURO-HEART study will provide the most comprehensive knowledge until date of children's neurologic prognosis in CHD and will have the potential for developing future clinical decisive tools and improving preventive strategies in CHD.

Trial registration

NCT02996630 , on 4th December 2016 (retrospectively registered).

SUBMITTER: Ribera I

PROVIDER: S-EPMC6737686 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol.

Ribera I I Ruiz A A Sánchez O O Eixarch E E Antolín E E Gómez-Montes E E Pérez-Cruz M M Cruz-Lemini M M Sanz-Cortés M M Arévalo S S Ferrer Q Q Vázquez E E Vega L L Dolader P P Montoliu A A Boix H H Simões R V RV Masoller N N Sánchez-de-Toledo J J Comas M M Bartha J M JM Galindo A A Martínez J M JM Gómez-Roig L L Crispi F F Gómez O O Carreras E E Cabero L L Gratacós E E Llurba E E

BMC pediatrics 20190910 1

<h4>Background</h4>Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns. While advances in early diagnosis and postnatal management have increased survival in CHD children, worrying long-term outcomes, particularly neurodevelopmental disability, have emerged as a key prognostic factor in the counseling of these pregnancies.<h4>Methods</h4>Eligible participants are women presenting at 20 to < 37 weeks of gestation carrying a fetus with CHD. Mate ...[more]

PMID: 31506079

Similar Datasets

Project description:Congenital structural heart disease (CHD) is the leading cause of infant death from birth defects. Postnatal survival primarily depends on the type and severity of the defect. In addition, worse cardiac prognosis is observed when extra-cardiac anomalies (ECA) are associated. This retrospective chart review was aimed at finding markers for short-term outcome prediction of prenatally-diagnosed complex CHD, focusing in particular on the impact of CHD category, of CHD severity score and of prenatal or postnatal diagnosis of ECA or chromosomal anomalies on 4 primary outcomes: termination of pregnancy (TOP), intrauterine fetal demise, neonatal mortality and 1-year-survival rate. We reviewed medical files from 381 fetuses, presenting at our center between 2018 and 2021 with CHD for which prenatal advice by a pediatric cardiologist was sought. 341 fetuses met the inclusion criteria for the study. Twin pregnancies (7.62%; OR 4.76 (p < 0.001)) and pregnancies resulting from assisted reproductive technology (7.33%; OR 2.44 (p < 0.001)) were more prevalent compared to the general population. CHD categories and CHD severity scores, ranging from A (extremely high risk based on CHD or ECA type) to D (low risk), were assigned to each fetus. Prenatal or postnatal chromosomal microarray results were available for 232 fetuses (68%) and were abnormal in 30 (12.9%). Logistic regression analysis was used to determine significant predictors for the primary outcomes 'TOP', 'postnatal demise before the age of 1 month' and 'survival at the age of 1 year'. TOP was carried out significantly more with: prenatal genetic diagnosis, severity score A and severity score B. Interestingly, a prenatal genetic diagnosis was negatively correlated with pregnancy continuation, but it was not a significant predictor for postnatal mortality, while a postnatal diagnosis of a genetic disorder impacted early but not late postnatal mortality. In addition, postnatal mortality both before the age of 1 month or before the age of 1 year was significantly associated with lower postmenstrual age at birth, CHD severity score B and major ECA at birth. These results underscore the importance of genotyping and of accurate cardiac and extracardiac phenotyping for prognostication in fetuses with CHD.

Project description:ImportanceA recent advisory from the American Heart Association delineated the potential benefits of developmental care for hospitalized children with congenital heart disease (CHD) and a critical gap in research evaluating the association of such inpatient programs with neurodevelopmental outcomes.ObjectiveTo investigate associations between the Cardiac Inpatient Neurodevelopmental Care Optimization (CINCO) program interventions, delirium, and neurodevelopment in young children (newborn through age 2 years) hospitalized with CHD.Design, setting, and participantsThis cohort study used quality improvement data from inpatient cardiac units at a tertiary care children's hospital in the US. Participants were children aged 0 to 2 years who were admitted for at least 7 days from September 1, 2018, to September 1, 2023. The CINCO program was implemented on September 1, 2020, in 6-month plan-do-study-act phases.ExposuresThe 5 CINCO interventions were medical and/or nursing order panels, developmental kits, bedside developmental plans, caregiver mental health support handouts, and developmental care rounds.Main outcomes and measuresNumber of days with delirium per patient, which was measured using the Cornell Assessment of Pediatric Delirium (a score higher than 9 indicated delirium). Neurodevelopment was measured using the Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-4).ResultsThe full sample included 1331 qualifying admissions for 1019 unique pediatric patients (median [range] age at admission, 3.65 [0-34.62] months; 771 males [57.9%]), with a subcohort of 121 unique patients (median [range] age at admission, 0.00 [0-9.85] months; 77 males [63.6%]) whose initial hospitalization occurred before age 10 months and who underwent BSID-4 evaluation at age 12 months or older. The mean (SD) number of days with delirium per patient was stable for 2 years prior to CINCO implementation, decreased by 54.0% between phases 1 and 2 of the CINCO program (from 3.05 [0.60] to 1.38 [0.21]), and then remained stable over time. Each of the 5 CINCO interventions was associated with lower delirium after false discovery rate (FDR) correction (eg, medical and/or nursing order panel: B = -1.376 [95% CI, -1.767 to -0.986]; F2,1273 = 47.767; partial η2 = 0.036; P < .001). Mean (SD) BSID-4 cognitive index scores were stable for 2 years prior to implementation, higher between phases 1 and 2 of the program (from 81.67 [14.14] to 93.92 [19.43]), and then remained stable over time. Four of the 5 interventions were associated with higher BSID-4 cognitive scores after FDR correction (eg, bedside developmental plans: B = 8.585 [95% CI, 2.247-14.923]; F5, 101 = 7.221; partial η2 = 0.067; P = .008). Delirium was associated with lower BSID-4 cognitive scores. There were no associations between delirium and BSID-4 language or motor scores.Conclusions and relevanceThis cohort study found that among hospitalized children with CHD, the implementation of an inpatient developmental care program was associated with reduced incidence of delirium and higher cognitive scores. Pediatric cardiac centers may consider adopting these low-cost, low-risk, generalizable program interventions.

Dataset Information

Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol.

Background

Methods

Discussion

Trial registration

Publications

Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets