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Completed

NCT Number: NCT04782635

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

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 ).

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed Forces Institute of Cardiology and National Institute of Heart Disease, Rawalpindi, Punjab Province, Pakistan

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About this study

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:

  • 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.
  • 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
  • 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.
  • 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

  • Name
  • Gender
  • Age (months )
  • Ethnicity
  • Weight (lbs)
  • Height (cm)
  • Percentile (Weight for age )
  • Z score (weight for age )
  • Phone No:
  • Address
  • Education level of mother father
  • Smart phone knowledge (low/medium/high)
  • Monthly income
  • No of siblings
  • No. of family members
  • No of smart phones at home
  • Diagnosis
  • Primary surgery
  • RACH score (class 1/class 2)
  • CVA yes/no
  • Creatinine ________
  • Hb ________
  • Albumin level _______
  • Number of days in hospital
  • Number of days in ICU
  • Ventilator time
  • Reopened yes/ no
  • Food allergy Wheat ________ Milk __________ Nuts __________ Eggs___________ Other ___________
  • Anorexia yes/ no
  • Muscle dystrophy yes/ no
  • Calories required
  • Proteins required
  • Carbohydrates required
  • Fats required
  • All vitamins will be listed (required)
  • All minerals will be listed (required)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mobile based application

Device

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

PAMPHLET

Behavioral

A pamphlet which will be provide knowledge to the patients

Primary outcomes

  1. Weight changes

    Time frame: 2 months

    observe the Weight changes , weight for age , Z score weight for age in both groups

  2. Caloric intake

    Time frame: 2 months

    Check the average calories intake consumed in both groups

  3. Proteins intake

    Time frame: 2 months

    Check the average proteins consumed in both groups

  4. Mobile application usage

    Time frame: 2 months

    Patients will be asked whether the language used in application on a likert scale ranging from very easy to very difficult , handling application will be ranging from very easy to very difficult, cost effectiveness will be ranging from yes to very costly, Visual cues in application will be ranged from useful to difficult to understand, Recipes in application will be ranged from being Useful to not useful, Meal reminders will be ranged from being useful to irritating

  5. nutritional issues

    Time frame: 2 months

    Patient will be inquired regarding the episodes of vomiting, diarrhea, loss of appetite and other nutritional related problems

Secondary outcomes

  1. carbohydrates intake

    Time frame: 2 months

    Measure average carbohydrates consumed in both groups (intervention and usual care group) in mg

  2. fats intake

    Time frame: 2 months

    Measure average fats consumed in both groups (intervention and usual care group) in mg

  3. Vitamins intake

    Time frame: 2 months

    Measure average vitamins consumed in both groups (intervention and usual care group) in mg and µg

  4. Minerals intake

    Time frame: 2 months

    Measure average minerals consumed in both groups (intervention and usual care group) in mg and µg

Sponsors and collaborators

Lead sponsor

Al-Shifa Trust Eye Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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