Preterm Birth Clinical Trial
Official title:
Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
Verified date | February 2024 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | July 30, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Federal do Rio Grande do Sul | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Bill and Melinda Gates Foundation |
Brazil,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body composition | Body composition is evaluated by bioelectrical impedance analysis (BIA) (InBody 770, Biospace Co Ltd). Each participant is positioned in an orthostatic position on a platform with lower electrodes for the feet and the hands holding onto upper electrodes. The measurement is performed after 2 hours fasting and diapers are changed before the evaluation. | 1 day of evaluation | |
Secondary | Child Eating Behaviour | Children's eating behavior is evaluated with the Brazilian validated and translated Children's Eating Behavior Questionnaire (CEBQ). The CEBQ is a Likert-type, parent-report rating scale measuring the variation in eating behavior in children, and consists of 35 items comprising eight subscales (Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating, and Food fussiness). Parents are asked to rate their child's eating behavior on a five-point scale (never, rarely, sometimes, often, always; 1-5, respectively). A higher mean score for each specific sub-scale suggests the child shows a higher tendency toward the respective eating behavior. | 1 day of evaluation | |
Secondary | Individual differences in parenting feeding styles | Parents should complete the 19-item Child Feeding Styles and Practices Questionnaire (CFSQ). Each item is scored from 1 (never) to 5 (always). Scores are averaged and categorized into one of four feeding styles: authoritative, authoritarian, indulgent, and uninvolved; higher scores represent more of the feeding style. | 1 day of evaluation | |
Secondary | Nutritional Assessment in Behavioral Pediatrics | Behavioral Pediatrics Feeding Assessment Scale (BPFAS) is a parent-report questionnaire with 35 questions, which examines the frequency of child behaviors (e.g., will try new foods) and frequency of parent feelings and strategies for dealing with eating problems (e.g., frustration when feeding a child, cajoling or threatening in response to frustration when feeding) using a five-point Likert scale from "never" to "always." Parents are also asked to rate whether each item is a problem by answering with a "yes" or "no". | 1 day of evaluation | |
Secondary | Feeding practice | The child's eating habits are evaluated through a questionnaire that seeks to understand the quality of food since birth. This questionnaire comprises information on breastfeeding, use of infant formula, and food introduction, including the period when 20 specific foods were introduced. They are sugary foods, treats, protein sources, caffeine, and vegetables. In addition to this questionnaire, a 24-hour food recall of the child is requested. | 1 day | |
Secondary | Anthropometric evaluation of children and a parent respecting body weight. | The trained research team measures the body weights (in kilograms = kg) of the children and a parent with the method described by the World Health Organization (WHO) using the same measuring instruments. Measurements are performed using a standardized digital scale U.R. 10.000 Light. | 1 day of evaluation | |
Secondary | Anthropometric evaluation of children and a parent respecting height. | The trained research team measures the height (in centimeters = cm) of the children and a parent, using the same wall stadiometer Sanny®, with individuals in an upright position, their heels, back, and head touching the equipment, the latter in a Frankfort plane. | 1 day of evaluation | |
Secondary | Anthropometric evaluation of children and a parent respecting skinfold. | The trained research team measures the skinfolds of the children and a parent, measured with a skinfold caliper Lange®, using the anthropometry technique described by ISAK. The subscapular and triceps skinfolds are measured. | 1 day of evaluation | |
Secondary | Anthropometric evaluation of children and a parent respecting circumferences. | The trained research team measures the circumferences of the children and a parent using a measuring tape. Waist and arm circumference is evaluated in all individuals, as well as head circumference in children. | 1 day of evaluation | |
Secondary | Z-score calculations of all participants using WHO ANTHRO program. | The anthropometric (height-for-age, weight-for-age; body mass index-for-age) measurements are evaluated according to the Z-score using the WHO ANTHRO program and WHO ANTHRO Plus Software. | 1 day of evaluation | |
Secondary | Physical Activity questionnaire | The questionnaire estimates the sedentary and active time of children, separated into weekdays or weekends, and day shifts (morning, afternoon, and night). The measure of physical activity is expressed by the daily time of participation in games and outdoor play while the measure of sedentary behavior is based on the time of watching television. | 1 day of evaluation | |
Secondary | Physical capacity Assessment | Physical capacity using Six Minutes Walk Test following the guidelines of American Thoracic Society (ATS), in a corridor of 30 meters. | 1 day of evaluation |
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