Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
NCT05399667 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180
Last updated 2024-10-17
Summary
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.
Conditions
- Preterm Birth
- Very Low Birth Weight Infant
- Early Intervention
- Parent-Child Relations
- Nutrition, Healthy
Interventions
- OTHER
-
Early stimulation
Preterm born children submitted to skin-to skin care (kangaroo care ) plus massage therapy by their mothers. This group received tactile-kinesthetic stimulation by mothers from randomization until hospital discharge. Intervention performed exclusively by the mothers was based on studies regarding the application of skin stimulations and passive exercises in preterm infants
- OTHER
-
Conventional care
Preterm born children submitted to skin-to skin care by their mothers (kangaroo care), associated to standard care according to the routine care in the Neonatal Intensive Care Unit (NICU).
Sponsors & Collaborators
-
Bill and Melinda Gates Foundation
collaborator OTHER -
Hospital de Clinicas de Porto Alegre
lead OTHER
Principal Investigators
-
Juliana R Bernardi, Prof PhD · Federal University of Rio Grande do Sul
Eligibility
- Min Age
- 3 Years
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-01-31
- Primary Completion
- 2024-12-01
- Completion
- 2024-12-30
Countries
- Brazil
Study Locations
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