The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Location status: Recruiting
Location contact
Jiajie Fan, PhD
CONTACT
Xiujing Wu
CONTACT
Xiujing Wu
PRINCIPAL_INVESTIGATOR
NCT Number: NCT03626480
The purpose of our multi-center cohort study is to build a large platform to follow up the peri-operative nutrition of children with congenital heart disease. And data will be collected pre and 1, 3, 6, 12 months post surgery including physical, laboratory, imaging examination and questionnaire. The primary outcome is nutrition status (measured as WAZ, WHZ and HAZ) and secondary outcomes were the biochemical index and quality of life.
Interested in participating?
Request Info1 day–12 month
All sexes
Observational
Hangzhou, Zhejiang, China
Location status: Recruiting
Jiajie Fan, PhD
CONTACT
Xiujing Wu
CONTACT
Xiujing Wu
PRINCIPAL_INVESTIGATOR
Children with congenital heart disease need surgery. However, extracorporeal circulation surgery can lead to systemic inflammatory reaction and ischemia, while reperfusion injury leads to metabolic disorders, with increased metabolism, hyperbolism and reduced anabolism. The redistribution of systemic blood and the ischemic and microcirculatory disorder state of gastrointestinal tract cause damage to the gastrointestinal mucosa and indigestion. Excessive fluid limitation after surgery and positive application of positive inotropic drugs were positively correlated with energy metabolism rate. Additionally, the lack of scientific feeding knowledge and poor eating habits of parents can increase the risk of malnutrition in children. Surgery is the most effective way of treating congenital heart disease. Although the cardiac malformation has been corrected and the heart function has been returned to normal, there are still some children cannot quickly get rid of malnutrition. To our knowledge, postoperative malnutrition affects wound healing in the short term. Long-term malnutrition and lack of calories and protein intake lead to the lack of trace elements, low immune function, easy secondary infection, and affect children's heart, organ function and intellectual development. In conclusion, this group of children with congenital heart disease should draw more extensive attention. And the scientific and reasonable feeding knowledge of infants should be widely carried out, which has far-reaching significance. Therefore, this multi-center cohort study is proposed.
We purposed to carry out a multi-center cohort study, and all infants under 1 year old with congenital heart disease undergone surgery in these hospitals were included. We aimed to follow up a long-term, tracking the nutrition status and motor development. The eligible patients in Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Gansu Provincial Maternity and Child-care Hospital, Zhengzhou Cardiovascular hospital, The Children's Hospital Zhejiang University school of medicine will be included. The baseline data will be collected before surgery, and physical, laboratory and imaging examination will be follow at pre and 1, 3, 6, 12 months post surgery to tracking the change of nutrition status (measured as WAZ, WHZ and HAZ). Questionnaires including emotional and social scales will be assigned pre and post surgery for causal inference and life quality evaluation.
The benefits of our follow up were:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No treatment
Time frame: baseline, 1, 3, 6 and 12 months
Measured as : WAZ (weight-for-age z-score), WHZ (weight-for-height z-score), HAZ (height-for-age z-score). Children's height and weight will be measured pre and 1, 3, 6, 12 months post surgery.
Time frame: baseline, 1, 3, 6 and 12 months
Infants' Albumin, prealbumin, retinol binding protein (RBP), transferrin (FER) and Amino terminal brain natriuretic peptide precursor (NT-proBNP) will be tested pre and 1, 6 months post surgery.
Infants' Hemoglobin, microelement, cholesterol, triglyceride and 25-hydroxy vitamin D3 will be tested pre and 3, 12 months post surgery.
Time frame: baseline, 1, 3, 6 and 12 months
ROSS score will be evaluated at pre and 1, 3, 6, 12 months post surgery. According to Ross RD, Bollinger RO, Pinsky WW (1992) Grading the severity of congestive heart failure in infants. Pediatr Cardiol 13:72-75. Ross scoring system for heart failure in infants grades the presence and severity of congestive heart failure based on the following variables: amount of formula consumed per feeding, feeding time, history of diaphoresis or tachypnea, growth parameters, respiratory and heart rates, respiratory pattern, perfusion, presence of edema, diastolic filling sounds, and hepatomegaly.
Time frame: baseline, 1, 3, 6 and 12 months
AIMS score will be evaluated at pre and 1, 3, 6, 12 months post surgery. The AIMS consists of 58 items at 4 different positions: prone (21 items), supine (9 items), sitting (12 items), and standing (16 items). The components tested for each item are based on 3 elements of movement: weight bearing, posture, and antigravity movements. For any item observed by the examiner, 1 point is given, whereas 0 points are given when the item is not observed. The sum of all items observed gives the total raw score, ranging from 0 to 58. The total raw score also can be converted into a percentile rank. High percentile ranks indicate maturity of the infant's gross motor skills.
Contact information is provided by the study sponsor or research team.
Lijuan Li, MD
CONTACT
Yanqin Cui, MPh
CONTACT
Guangzhou Medical University
Other
A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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