Peri-operative Nutrition in Infants With Congenital Heart Disease

February 7, 2020 updated by: Yanqin Cui, Guangzhou Medical University

A Multi-center Longitudinal Cohort Study on 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Children's Hospital of Zhejiang University School of Medicine
        • Contact:
        • Contact:
          • Xiujing Wu
          • Phone Number: 13868171697
        • Principal Investigator:
          • Xiujing Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants under 1 years old in the multi-center with congenital heart disease and planed to surgery

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 1, 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 1, 3, 6 and 12 months
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.
baseline, 1, 3, 6 and 12 months
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.
baseline, 1, 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Collaborators

The Children's Hospital of Zhejiang University School of Medicine
Gansu Provincial Maternity and Child-Care Hospital
Dalian Children's Hospital

Investigators

  • Principal Investigator: Yanqin Cui, MPh, Guangzhou Women And Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2018

Primary Completion (ANTICIPATED)

September 1, 2028

Study Completion (ANTICIPATED)

September 1, 2028

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (ACTUAL)

August 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018080101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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