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NCT05399667
Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
trial testing Early stimulation in Preterm Birth in 180 participants. Participants enrolled and being followed up; not accepting new ones.
1 December 2024
Quick facts
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 180 |
| Start date | 31 January 2020 |
| Primary completion | 1 December 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Early stimulation
- Conventional care
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
- Very Low Birth Weight Infant — all drugs for Very Low Birth Weight Infant →
- Early Intervention — all drugs for Early Intervention →
- Parent-Child Relations — all drugs for Parent-Child Relations →
Sponsor
Hospital de Clinicas de Porto Alegre
Who can join
Adults 3 to 6, any sex, with Preterm Birth or Very Low Birth Weight Infant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05399667
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05399667 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre
- Last refreshed: 17 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05399667.
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