Peri-operative Nutrition in Infants With Congenital Heart Disease
ConditionCongenital Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorGuangzhou Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
(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 population
Infants under 1 years old in the multi-center with congenital heart disease and planed to surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No treatment
Other interventionNo treatment
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline, 1, 3, 6 and 12 monthsSecondary outcomes
1
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.
Time frame
baseline, 1, 3, 6 and 12 months2
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.
Time frame
baseline, 1, 3, 6 and 12 months3
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.
Time frame
baseline, 1, 3, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangzhou Medical University
Lead sponsor
Guangzhou Women and Children's Medical Center
Sponsor institution
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
Dalian Children's Hospital
Collaborator
Source ClinicalTrials.gov