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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05399667 on ClinicalTrials.gov