Identification of risk factors affecting catch-up growth after infant congenital heart disease surgery: rationale and design of a multicentre prospective cohort study in China

Abstract

IntroductionSuccessful surgical treatment of congenital heart disease improves neonates’ long-term survival and leads to catch-up growth, which however does not occur in part of the patient population for largely undetermined reasons.Methods and analysisA multicentre, prospective cohort study is being conducted in four paediatric medical institutions in China to collect detailed nutritional, anthropometric and clinical data at perioperative phases and during a 1-year period of follow-up after surgery. The study is expected to recruit approximately 5000 patients by the year of 2023 when the cohort is fully established. The primary endpoint of this study is the occurrence of postoperative catch-up growth, which will be determined in both absolute and relative terms (ie, reduced anthropometric deficits from the reference measures and improved z-scores that have passed the −2 SD cut-offs). Multivariable regression analyses will be performed to identify factors that are statistically significantly associated with the absence of postoperative catch-up growth.Ethics and disseminationThe protocol of this study has been approved by the individual ethics committees of the participating centres (Guangzhou Women and Children’s Medical Centre (2008071601), the Children’s Hospital of Zhejiang University School of Medicine (2018-IRB-094), Gansu Provincial Maternity and Child-Care Hospital (2019-IRB-01) and Zhengzhou Cardiovascular Hospital (2019012001)). Written informed consent from parents will be obtained before study entry. Findings of this study will be disseminated through publications in international peer-reviewed journals and will be presented in academic conferences.

Prevalence and predictive factors of malnutrition in Thai children with congenital heart disease and short-term postoperative growth outcomes

“…Furthermore, the number of CHD patients aged older than five years in the present study was small and did not have adequate power to make a strong conclusion. Previously, several studies found that CHD patients could catch-up growth significantly after corrective cardiac surgery in both cyanotic and acyanotic CHD (Carmona et al, 2012;Cheung et al, 2003;Li et al, 2019). Martins et al, demonstrated that early VSD closure resulted in significant acceleration of post-operative growth within 3-6 months in both term and preterm infants (Correia Martins et al, 2016).…”

Early Growth Trajectory of Infants With Simple Congenital Heart Disease and Complex Congenital Heart Disease Undergoing Cardiac Repair: A Prospective Cohort Study in China

“…This is a prospective cohort study carried out at Guangzhou Women and Children's Medical Center in China (registration number: NCT03626480), and the details of this longitudinal cohort study have been previously published 15 . In summary, we included patients admitted to a single academic center (Guangzhou Women and Children's Medical Center) with a diagnosis of CHD according to the International Classification for Diseases, 10th version 16 .…”

Cohort protocol: Guangzhou High-Risk Infant Cohort study

“…The GHRIC study is primarily an epidemiological investigation without any predefined statistical hypothesis to test, making a priori sample size calculation unnecessary. 21 In designing this study, we wished to ensure that we obtained the correct answers in the most efficient way, so that the work that we do will be worthwhile. Therefore, we will enrol enough HRIs to give our results adequate power, but not too many that we waste time gathering more data than we need.…”