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

NCT05399667 | Active Not Recruiting

• 1 other identifier: 2019-0809
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Child Eating Behaviour

  1 day of evaluation

• Individual differences in parenting feeding styles

  1 day of evaluation

• Nutritional Assessment in Behavioral Pediatrics

  1 day of evaluation

• Feeding practice

  1 day

• Anthropometric evaluation of children and a parent respecting body weight.

  1 day of evaluation

Study Arms (3)

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).

Other: Early stimulation

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).

Other: Conventional care

Control group

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

Interventions

Early stimulation 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

Early stimulation

Conventional care 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).

Conventional care

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related 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.

  PMID: 30737045 BACKGROUND

• 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.

  PMID: 22119478 BACKGROUND

• 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.

  PMID: 28678222 BACKGROUND

• 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.

  PMID: 11718230 BACKGROUND

• 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.

  PMID: 11693591 BACKGROUND

• 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.

  PMID: 30092772 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Juliana R Bernardi, Prof PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 1, 2022
• Study Start: January 31, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

BR (1)