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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05399667
• Other study ID #: 2019-0809
• Status: Active, not recruiting
• Start date: January 31, 2020
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Birth Weight
• Early Intervention
• Parent-Child Relations
• Premature Birth
• Preterm Birth
• Very Low Birth Weight Infant

Intervention

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
• 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).

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Andrews ET, Beattie RM, Johnson MJ. Measuring body composition in the preterm infant: Evidence base and practicalities. Clin Nutr. 2019 Dec;38(6):2521-2530. doi: 10.1016/j.clnu.2018.12.033. Epub 2019 Jan 12. — View Citation

Crist W, Napier-Phillips A. Mealtime behaviors of young children: a comparison of normative and clinical data. J Dev Behav Pediatr. 2001 Oct;22(5):279-86. doi: 10.1097/00004703-200110000-00001. — View Citation

Hughes SO, Cross MB, Hennessy E, Tovar A, Economos CD, Power TG. Caregiver's Feeding Styles Questionnaire. Establishing cutoff points. Appetite. 2012 Feb;58(1):393-5. doi: 10.1016/j.appet.2011.11.011. Epub 2011 Nov 15. — View Citation

Oliveira NKR de, Lima RA de, Mélo EN, Santos CM, Barros SSH, Barros MVG de. Reliability of a questionnaire to assess physical activity and sedentary behavior in preschool-aged children. Rev. Bras. Ativ. Fís. Saúde [Internet];2011; 16(3):228-33. https://rbafs.org.br/RBAFS/article/view/597

Saenz de Pipaon M, Dorronsoro I, Alvarez-Cuervo L, Butte NF, Madero R, Barrios V, Coya J, Martinez-Biarge M, Martos-Moreno GA, Fewtrell MS, Argente J, Quero J. The impact of intrauterine and extrauterine weight gain in premature infants on later body composition. Pediatr Res. 2017 Oct;82(4):658-664. doi: 10.1038/pr.2017.123. Epub 2017 Jul 5. — View 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. — View Citation

Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792. — View Citation

Outcome

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