Preterm BirthNCT05399667
Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
An observational study of Preterm Birth and Very Low Birth Weight Infant, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Very Low Birth Weight Infant, Early Intervention
- What is being tested?
- Early stimulation and Conventional care
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jan 2020to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
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.
Read the 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.
- Conditions
- Preterm Birth, Very Low Birth Weight Infant, Early Intervention, Parent-Child Relations, Nutrition, Healthy
- Being tested
- Early stimulation, Conventional care
- Keywords
- prematurity, very low birth weight, early intervention, parent-child relations, nutritional health, body composition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early stimulationOther
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 careOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Conventional care | |
| Control group | Term born children to obtain reference values for the variables evaluated in the present study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day of evaluation
Secondary outcomes (11)
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.
Measured: 1 day of evaluation
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.
Measured: 1 day of evaluation
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".
Measured: 1 day of evaluation
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.
Measured: 1 day
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.
Measured: 1 day of evaluation
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.
Measured: 1 day of evaluation
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.
Measured: 1 day of evaluation
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.
Measured: 1 day of evaluation
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.
Measured: 1 day of evaluation
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.
Measured: 1 day of evaluation
Physical capacity Assessment
Physical capacity using Six Minutes Walk Test following the guidelines of American Thoracic Society (ATS), in a corridor of 30 meters.
Measured: 1 day of evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start31 Jan 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Juliana R Bernardi, Prof PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399667
- Sponsor's protocol ID
- 2019-0809
- Status last verified
- Oct 2024
- First submitted
- 25 May 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30737045Hughes 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.
PubMed 22119478Saenz 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.
PubMed 28678222Crist 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.
PubMed 11718230Wardle 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.
PubMed 11693591Silveira 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.
PubMed 30092772Oliveira 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
- ClinicalTrials.gov ID
- NCT05399667
- Acronym / sponsor ID
- 2019-0809
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early stimulation | – | Other: Early stimulationSkin-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). |
| Conventional care | – | Other: Conventional careStandard 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). |
| Control group | – | –Term born children to obtain reference values for the variables evaluated in the present study. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early stimulationPreterm 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 | Other | Early stimulation |
| Conventional carePreterm 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). | Other | Conventional care |
Primary outcome
Body composition
Time frame: 1 day of evaluation
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.
11 secondary outcomes
Child Eating Behaviour
Time frame: 1 day of evaluation
Individual differences in parenting feeding styles
Time frame: 1 day of evaluation
Nutritional Assessment in Behavioral Pediatrics
Time frame: 1 day of evaluation
Feeding practice
Time frame: 1 day
Anthropometric evaluation of children and a parent respecting body weight.
Time frame: 1 day of evaluation
Anthropometric evaluation of children and a parent respecting height.
Time frame: 1 day of evaluation
Anthropometric evaluation of children and a parent respecting skinfold.
Time frame: 1 day of evaluation
Anthropometric evaluation of children and a parent respecting circumferences.
Time frame: 1 day of evaluation
Z-score calculations of all participants using WHO ANTHRO program.
Time frame: 1 day of evaluation
Physical Activity questionnaire
Time frame: 1 day of evaluation
Physical capacity Assessment
Time frame: 1 day of evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 30737045Andrews 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.
- Background: PubMed 22119478Hughes 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.
- Background: PubMed 28678222Saenz 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.
- Background: PubMed 11718230Crist 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.
- Background: PubMed 11693591Wardle 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.
- Background: PubMed 30092772Silveira 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.
- BackgroundOliveira 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana R Bernardi, Prof PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Very Low Birth Weight Infant, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 1 day of evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399667, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.