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Effect of carbohydrate-rich solutions on gastric emptying in children

Mother project: "Effect of administering different carbohydrate-rich solutions on gastric emptying in pediatric patients: Randomized controlled trial" Subproject I: "Ultrasound evaluation of gastric volume in children undergoing upper digestive endoscopy after ingestion of different carbohydrate-enriched solutions compared with fasting pediatric patients: a randomized controlled trial" Subproject II: "Effects of the administration of different carbohydrate-rich solutions on gastric emptying, assessed by upper digestive endoscopy, in pediatric patients: Randomized controlled trial"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8d9hxj
Enrollment
Unknown
Registered
2019-11-13
Start date
2017-09-29
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting

Interventions

All patients will undergo abdominal ultrasound for evaluation of gastric volume, and subsequently will be randomized into four groups of 30 children each. The volunteer children should be between 3 an
E01.370.372.250.250
E01.370.350.850

Sponsors

Faculdade de Medicina de Botucatu da Universidade Estadual Júlio de Mesquita Filho
Lead Sponsor
Faculdade de Medicina de Botucatu da Universidade Estadual Júlio de Mesquita Filho
Collaborator

Eligibility

Age
3 Years to 15 Years

Inclusion criteria

Inclusion criteria: Age between 3 and 15 years; elective upper digestive endoscopy; written authorization from parents or legal representatives through the Free and Informed Consent Form, in the case of children aged 3 to 12 years; over 12 years old, authorization by an Informed Consent Form.

Exclusion criteria

Exclusion criteria: Use of nasoenteric tube; Unstable clinical situation; Presence of encephalopathies; History of gastroparesis; History of recent upper gastrointestinal bleeding (more than 1 month); Previous surgery of distal stomach or esophagus; Vomiting after solution consumption; Children whose parents or legal guardians do not agree to participate; Non-aspirable intra-gastric content

Design outcomes

Primary

MeasureTime frame
To evaluate the volume of residual gastric content in children after carbohydrate-rich fluid consumption, verified by gastric volume ultrasound and the gastric content aspiration method by upper digestive endoscopy. We will look at whether there is an increase in gastric residual volume after substance consumption and whether the volume may predict a risk for bronchoaspiration.;To evaluate the quality of upper digestive endoscopy examination, verified by the upper digestive endoscopy method. We will observe whether there are differences in substances in the evaluation of the upper gastrointestinal tract mucosa after substance consumption—

Secondary

MeasureTime frame
To evaluate the applicability of the mathematical model for estimating the volume of gastric content by ultrasonography.;Caso não seja esperado nenhum outro desfecho secundário, o campo deve ser preenchido da seguinte maneira: Não são esperados desfechos secundários—

Countries

Brazil

Contacts

Public ContactGustavo Lima

Faculdade de Medicina de Botucatu da Universidade Estadual Júlio de Mesquita Filho

grdlima@uol.com.br+55-14-38801001

Outcome results

None listed

Source: REBEC (via WHO ICTRP)