Congenital Heart DiseaseNCT03626480
Peri-operative Nutrition in Infants With Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- No treatment
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2018to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- Child
Study population: Infants under 1 years old in the multi-center with congenital heart disease and planed to surgery
Who may be able to join
- 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,
Who cannot join
- (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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jiajie Fan, PhD, 13634105687, jiajiefan@163.com
Xiujing Wu, 13868171697
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Congenital Heart Disease
- Being tested
- No treatment
- Keywords
- Surgery, Nutritional outcome, Infants
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatmentOther
No treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infants' height and weight
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.
Measured: baseline, 1, 3, 6 and 12 months
Secondary outcomes (3)
Change of Biomedical index level
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.
Measured: baseline, 1, 3, 6 and 12 months
Change in ROSS score
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.
Measured: baseline, 1, 3, 6 and 12 months
Change in Alberta Infant Motor Scale (AIMS)
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.
Measured: baseline, 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start9 Jul 2018
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital, The Children's Hospital of Zhejiang University School of Medicine, Dalian Children's Hospital
- Responsible party
- Principal investigator, Yanqin Cui, Guangzhou Women and Children's Medical Center
- Investigators
- Yanqin Cui, MPh, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626480
- Sponsor's protocol ID
- 2018080101
- Status last verified
- Feb 2020
- First submitted
- 1 Aug 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Longitudinal Cohort Study on Peri-operative Nutrition in Infants With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03626480
- Acronym / sponsor ID
- 2018080101
- Conditions
- Congenital Heart Disease
- Keywords
- Surgery, Nutritional outcome, Infants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital, The Children's Hospital of Zhejiang University School of Medicine, Dalian Children's Hospital
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Infants under 1 years old in the multi-center with congenital heart disease and planed to surgery
Key inclusion criteria (5 listed)
- All children in the multi-center who met the following criteria:
Key exclusion criteria (1 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatmentNo treatment | Other | – |
Primary outcome
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.
3 secondary outcomes
Change of Biomedical index level
Time frame: baseline, 1, 3, 6 and 12 months
Change in ROSS score
Time frame: baseline, 1, 3, 6 and 12 months
Change in Alberta Infant Motor Scale (AIMS)
Time frame: baseline, 1, 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanqin Cui, MPh principal investigator
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lijuan Li, MD (8620-38076234, 397413149@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in infants' height and weight (time frame: baseline, 1, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.