Effect of Artificial Intelligence on Nutritional Status of Children Post Cardiac Surgery
Condition: Post-cardiac Surgery
Study type: Interventional

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)
    

Intervention name(s): mobile based application; Pamphlet
Intervention type(s): Device; Behavioral
Intervention description(s): 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; A pamphlet which will be provide knowledge to the patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care