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NCT05399667

Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program

Active, enrolled Last updated 17 October 2024
What this trial tests

trial testing Early stimulation in Preterm Birth in 180 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
31 January 2020
Primary endpoint
1 December 2024
30 December 2024

Quick facts

Lead sponsorHospital de Clinicas de Porto Alegre
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment180
Start date31 January 2020
Primary completion1 December 2024
Estimated completion30 December 2024
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

Adults 3 to 6, any sex, with Preterm Birth or Very Low Birth Weight Infant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program. The preterm-born children participated in the project entitle "Early Intervention Program for Preterm Infants and Their Parents: establishing the impact at 18 Months Corrected Age" (NCT02835612), which performed a continuous early stimulation in very and extremely preterm infant's families in their first 12 to 18 months. In the present study, preterm born children currently with 3 to 6 years old and their mothers (or legal guardian) are once more invited to a one-day visit for a nutritional and clinical evaluation at the Clinical Research Center of Hospital de Clínicas de Porto Alegre/Brazil. In the consultation, preterm born children and theirs mothers are submitted to the following exams: body composition by electrical bioimpedance, clinical and physical evaluation, anthropometric measurements, and children's eating habits, eating behavior and parental educational style in food through specific questionnaires. Moreover, this study will also investigate a group of pre-scholar health children born at term to obtain reference values for variables analysed. The goal with these findings is to determine if an early stimulation program could present a positive impact in anthropometric outcomes and nutritional aspects in this more vulnerable preterm born population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Preterm Birth

Currently open trials in the same condition.

Other Hospital de Clinicas de Porto Alegre trials

Trials by the same sponsor.

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Data sources for this page

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