Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery

Post-cardiac Surgery Clinical Trial

Official title: Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery

Status Completed

Clinical Trial 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 ).

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Post-cardiac Surgery

• NCT number: NCT04782635
• Study type: Interventional
• Source: Al-Shifa Trust Eye Hospital
• Status: Completed
• Phase: N/A
• Start date: March 25, 2021
• Completion date: August 3, 2021