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NCT Number: NCT03626480

Peri-operative Nutrition in Infants With Congenital Heart Disease

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.

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Key information

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Jiajie Fan, PhD

CONTACT

[email protected]

13634105687

Xiujing Wu

CONTACT

13868171697

Xiujing Wu

PRINCIPAL_INVESTIGATOR

About this study

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:

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All children in the multi-center who met the following criteria:
  • under 1 years old (including 1 years old);
  • diagnosed as congenital heart disease and planed to surgery;
  • parents have basic literacy skills, communication and accessibility
  • 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)

Treatment and study plan

No treatment

Other

No treatment

Primary outcomes

  1. Change in infants' height and weight

    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.

Secondary outcomes

  1. Change of Biomedical index level

    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.

  2. Change in ROSS score

    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.

  3. Change in Alberta Infant Motor Scale (AIMS)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lijuan Li, MD

CONTACT

[email protected]

8620-38076234

Yanqin Cui, MPh

CONTACT

[email protected]

8620-38076234

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Collaborators

  • Dalian Children's Hospital
  • Gansu Provincial Maternal and Child Health Care Hospital
  • The Children's Hospital of Zhejiang University School of Medicine

Registry information

Official study title

A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Aug 13, 2018
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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