Clinical trial NCT04782635: Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery
Official title: Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-cardiac Surgery
Lead sponsor: Al-Shifa Trust Eye Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 61
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the study will be to assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group.To assess usefulness of diet related mobile application in comparison to usual care group.To identify diet related problems among children post cardiac surgery in both groups (usual care group and intervention group ).

Detailed description: Research question Is there any impact of artificial intelligence on nutritional status of children post cardiac surgery?

Null hypothesis:

There is no impact of artificial intelligence on nutritional status of children post cardiac surgery

Operational definition:

1. Cardiac surgery There are large number of different surgical procedures (more than 150) in congenital heart disease, it became necessary the grouping into categories or relatively homogeneous strata, so that the comparisons between the outcomes were performed. The RACHS-1 method was developed by the Children's Hospital Boston team through a panel of 11 nationally representative members of pediatric cardiologists and cardiac surgeon. It allocated 207 surgical procedures in 6 different categories with similar risk for hospital mortality.
2. Artificial intelligence (AI) Artificial intelligence is a way to make machines think and behave intelligently. These machines are controlled by software inside them, so AI has a lot to do with intelligent software programs that can control these machines. It is a science that can help machines understand the world and accordingly react to situations in the same way the humans do.27
3. Nutritional status The state of a person's health in terms of the nutrients in his or her diet. Nutritional status assessment is the interpretation of anthropometric (using Length-for-age and Weight-for-age clinical growth charts and Z score), clinical (muscle dystrophy) and dietary data (food frequency table, usual dietary intake and mobile based application) to determine whether a person or groups of people are well nourished or malnourished.
4. Nutrition related mobile application Application basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles

Material and Methods:

STUDY DESIGN:

Randomized controlled trial

SETTING:

Tertiary Care Cardiac hospital, Rawalpindi , Pakistan.

SAMPLING TECNIQUE:

Permuted block BLINDING Double blinded study

SAMPLE SIZE:

Sample size is estimated to be 96, 48 in each group i.e. intervention and control group

DATA ANALYSIS PROCEDURE All data will be analyzed using SPSS 23 Descriptive statistics

* Percentages and frequencies for all categorical variables
* Categorical Data will be presented in form of bar and chart
* Mean and standard deviation for continuous data. Inferential statistics
* For comparison of characteristics of patients between usual care group and intervention group:
* Independent t-test for continuous variables
* Chi square for categorical variables
* Pre-test and post-test difference in mean changes will be assessed by Split-plot ANOVA
* To compare outcomes between usual care group and intervention group Chi square group will be used

Ethical consideration The study will start after presenting research proposal and obtaining ethical approval from Ethical Review Committee of Pakistan Institute of Ophthalmology, Al-Shifa School of Public Health. A formal letter will be used that will include the information relevant to the study e.g., the purpose and duration of this study, the level of privacy and confidentiality of information with anonymity of the respondents. While conducting this study, informed consent from all participants will be taken verbally and in written form. Participation will be voluntary and individuals will be informed that they can withdraw at any time and that all data will be treated confidentially. Subjects will be assured of anonymity and confidentiality. Patients will be given a broad outline of the research, an indication of the type of information that is required, the reasons why the research is being carried out and how the information which they provided will be used.

Independent variable

1. Name
2. Gender
3. Age (months )
4. Ethnicity
5. Weight (lbs)
6. Height (cm)
7. Percentile (Weight for age )
8. Z score (weight for age )
9. Phone No:
10. Address
11. Education level of mother father
12. Smart phone knowledge (low/medium/high)
13. Monthly income
14. No of siblings
15. No. of family members
16. No of smart phones at home
17. Diagnosis
18. Primary surgery
19. RACH score (class 1/class 2)
20. CVA yes/no
21. Creatinine ________
22. Hb ________
23. Albumin level _______
24. Number of days in hospital
25. Number of days in ICU
26. Ventilator time
27. Reopened yes/ no
28. Food allergy Wheat ________ Milk __________ Nuts __________ Eggs___________ Other ___________
29. Anorexia yes/ no
30. Muscle dystrophy yes/ no
31. Calories required
32. Proteins required
33. Carbohydrates required
34. Fats required
35. All vitamins will be listed (required)
36. All minerals will be listed (required)

Eligibility criteria: Inclusion Criteria:

* Children of age 2-12 (early and middle childhood) years will be included in the study.
* Surgeries within first and second class of RACHS score are included in the study.
* Patients with smart phones and internet facilities are included in the study.
* Patients with caregivers who can read English are included in the study
* Patients discharged from the hospital will be selected

Exclusion Criteria:

* Patients with multiple congenital abnormalities and surgeries without an RACHS score are excluded.
* Patient who will be rehospitalized will be excluded from the research

Primary outcomes:
measure: Weight changes
timeFrame: 2 months
measure: Caloric intake
timeFrame: 2 months
measure: Proteins intake
timeFrame: 2 months
measure: Mobile application usage
timeFrame: 2 months
measure: nutritional issues
timeFrame: 2 months
Secondary outcomes:
measure: carbohydrates intake
timeFrame: 2 months
measure: fats intake
timeFrame: 2 months
measure: Vitamins intake
timeFrame: 2 months
measure: Minerals intake
timeFrame: 2 months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Cardiology and National Institute of Heart Disease
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Maryam Zahid
state: Punjab
Study officials:
References:
citation: Zahid M, Sughra U. Development of a protocol for conducting a randomized control trial on effects of artificial intelligence on nutritional status of children post cardiac surgery. J Pak Med Assoc. 2022 May;72(5):908-911. doi: 10.47391/JPMA.3751.