Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04782635 |
| Other study ID # |
AlShifaTrustEye |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 25, 2021 |
| Est. completion date |
August 3, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Al-Shifa Trust Eye Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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 ).
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)
