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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-31

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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The main goal of the present study is to investigate anthropometric and physical measurements of pre-scholar aged children born preterm and their parents submitted to an early stimulation program, as well as to investigate children's eating practices, children's eating behavior and parental educational style in feeding.

This currently study is a segment of a previous 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 preterm infant's families in their first 12 to 18 months. The previous study randomized preterm born children less than 32 weeks of gestational age and/or very low birth weight at Hospital de Clínicas de Porto Alegre (HCPA) - a tertiary hospital in south Brazil, in the following two groups: CONVENTIONAL GROUP (CG) that received standard care (skin-to skin care by mother, kangaroo care, and breast feeding policy) according to the routine care of the Neonatal Intensive Care Unit (NICU) and, after NICU discharge, they were referred for a traditional follow up clinic taking care of the demands according to their necessity. INTERVENTION GROUP (IG): Skin-to skin care by mother, kangaroo care, breastfeeding policy plus massage therapy were made by the mothers until hospital discharge. After discharge, they received standard follow up care plus orientation for a continuous global simulation at home. The early intervention was performed according to developmental milestones, anticipating in one month evolutional step acquisition of motor and/or cognitive expected for corrected age. Besides that, we have a total of 10 home visits promoting guidance and supervision sessions.

In the present study, preterm born children aging between 3 to 6 years old and their mothers (or legal guardian) are once more invited to a one-day visit in the Clinical Research Center of HCPA for nutritional and clinical evaluation. In the visiting day, research participants are submitted to the following exams: body composition by electrical bioimpedance (InBody 770), anthropometric measurements (weight, height, skinfold thickness), clinical and physical evaluation (6 minutes walt test) and children's eating habits, eating behavior and parental educational style in food through specific questionnaires, such as Behavioral Pediatrics Feeding Assessment Scale (BPFAS), Child Eating Behaviour Questionnaire (CEBQ) and Caregiver's Feeding Styles Questionnaire (CFSQ). Data from neonatal period and from the follow up in the clinical care will also be analysed to associate with current nutritional and clinical findings. In addition to preterm population, a group of term born health children and their mother will be invited to participate with the goal to access reference values of the parameters investigated. This group of term born children (\>37 weeks of gestational age and/or birth weight \>2500g) will be recruited from the daycare of our hospital institution.

It is expect with these findings to determine if an early stimulation program could present a positive impact in anthropometric outcomes and nutritional aspects of our more vulnerable preterm born population.

Conditions

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Preterm Birth Very Low Birth Weight Infant Early Intervention Parent-Child Relations Nutrition, Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Early stimulation

Skin-to skin care by mother, kangaroo care, breastfeeding policy plus massage therapy are made by the mothers until hospital discharge. After discharge, they receive standard follow up care plus orientation for a continuous global simulation at home (total of 10 home visits independently of the standard evaluation and care that will be performed; visits promoting guidance and supervision sessions).

Early stimulation

Intervention Type OTHER

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

Conventional care

Standard care according to the routine care of the Neonatal Intensive Care Unit (NICU) (skin-to skin care by mother, kangaroo care, and breast feeding policy) and their needs in the follow up program (motor, and cognition evaluations and interventions).

Conventional care

Intervention Type OTHER

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).

Control group

Term born children to obtain reference values for the variables evaluated in the present study.

No interventions assigned to this group

Interventions

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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

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Preterm children born at HCPA (birth weight \<1500g and/or gestational age \<32 weeks); Term born children (\> 37 weeks of gestational age and/or birth weight \>2500g)

Exclusion Criteria: Congenital malformations

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes