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BMJ Open. 2019 Aug 20;9(8):e030084. doi: 10.1136/bmjopen-2019-030084.

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.

BMJ open

Lijuan Li, Kuanrong Li, Caixia An, Jiajie Fan, Changying Guo, Suixin Liang, Yue Guo, Huimin Xia, Xinxin Chen, Yanna Zhu, Chunmei Hu, Wenyue Si, Huiying Liang, Yanqin Cui

Affiliations

  1. CICU, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
  2. Institute of Paediatrics, Guangzhou Women and Children's Medical Center, Guangzhou, China.
  3. CICU, Gansu Provincial Maternity and Child-Care Hospital, Lanzhou, China.
  4. CICU, The Children's Hospital of Zhejiang University School of Medicine, Hangzhou, China.
  5. CICU, Zhengzhou Cardiovascular Hospital, Zhengzhou, China.
  6. CICU, Shenzhen Children's Hospital, Shenzhen, China.
  7. Guangdong Key Laboratory of Structural Birth Defects, Guangzhou, China.
  8. Department of Maternal and Child Health, Sun Yat-sen University School of Public Health, Guangzhou, China.
  9. CICU, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China [email protected].

PMID: 31434778 PMCID: PMC6707667 DOI: 10.1136/bmjopen-2019-030084

Abstract

INTRODUCTION: Successful 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 ANALYSIS: A 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 DISSEMINATION: The 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.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: catch-up growth; congenital heart disease; prospective cohort

Conflict of interest statement

Competing interests: None declared.

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