Clinical trial NCT05399667: Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
Official title: Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Preterm Birth
Very Low Birth Weight Infant
Early Intervention
Parent-Child Relations
Nutrition, Healthy
Keywords: prematurity
very low birth weight
early intervention
parent-child relations
nutritional health
body composition
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2022-06-01
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm born children aging 3 to 6 years old who were born at Hospital de Clínicas de Porto Alegre and their mother.

Term born children aging 3 to 6 years old who are in the Daycare for the employes of the Hospital de Clínicas de Porto Alegre.

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Body composition
timeFrame: 1 day of evaluation
Secondary outcomes:
measure: Child Eating Behaviour
timeFrame: 1 day of evaluation
measure: Individual differences in parenting feeding styles
timeFrame: 1 day of evaluation
measure: Nutritional Assessment in Behavioral Pediatrics
timeFrame: 1 day of evaluation
measure: Feeding practice
timeFrame: 1 day
measure: Anthropometric evaluation of children and a parent respecting body weight.
timeFrame: 1 day of evaluation
measure: Anthropometric evaluation of children and a parent respecting height.
timeFrame: 1 day of evaluation
measure: Anthropometric evaluation of children and a parent respecting skinfold.
timeFrame: 1 day of evaluation
measure: Anthropometric evaluation of children and a parent respecting circumferences.
timeFrame: 1 day of evaluation
measure: Z-score calculations of all participants using WHO ANTHRO program.
timeFrame: 1 day of evaluation
measure: Physical Activity questionnaire
timeFrame: 1 day of evaluation
measure: Physical capacity Assessment
timeFrame: 1 day of evaluation
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Juliana R Bernardi, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Silveira RC, Mendes EW, Fuentefria RN, Valentini NC, Procianoy RS. Early intervention program for very low birth weight preterm infants and their parents: a study protocol. BMC Pediatr. 2018 Aug 9;18(1):268. doi: 10.1186/s12887-018-1240-6.
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