Clinical trial NCT03626480: Peri-operative Nutrition in Infants With Congenital Heart Disease
Official title: A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Keywords: Surgery
Nutritional outcome
Infants
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Gansu Provincial Maternal and Child Health Care Hospital
name: The Children's Hospital of Zhejiang University School of Medicine
name: Dalian Children's Hospital
First posted: 2018-08-13
Enrollment: 20000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants under 1 years old in the multi-center with congenital heart disease and planed to surgery

Brief summary: 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.

Detailed description: 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:

1. patients will be asked to come back to the clinic for periodic review at certain time；
2. specialized people conduct follow up the cohort study；
3. A website system had been established to collect the information of patients:

1) professional CRF forms were unified; 2) the website has quality control features. 3) specialized people are responsible for maintaining the website. 4) the website guarantee the long-distance multi-center communication. 5) the website has a reminder of follow-up.

Eligibility criteria: Inclusion Criteria:

* All children in the multi-center who met the following criteria:

  1. under 1 years old (including 1 years old);
  2. diagnosed as congenital heart disease and planed to surgery;
  3. parents have basic literacy skills, communication and accessibility
  4. parents are informed consent and volunteered to participate with the approval of the hospital ethics committee,

Exclusion Criteria:

* (1) suspected as chromosomal disease; (2) diagnosis of genetic metabolic diseases; (3) anyway affecting oral feeding (eg. Cleft palate) (4) previous gastrointestinal surgery (eg. Postoperative gastrointestinal fistula)

Primary outcomes:
measure: Change in infants' height and weight
timeFrame: baseline, 1, 3, 6 and 12 months
Secondary outcomes:
measure: Change of Biomedical index level
timeFrame: baseline, 1, 3, 6 and 12 months
measure: Change in ROSS score
timeFrame: baseline, 1, 3, 6 and 12 months
measure: Change in Alberta Infant Motor Scale (AIMS)
timeFrame: baseline, 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Yanqin Cui, MPh
role: PRINCIPAL_INVESTIGATOR
References: