- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05498753
Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Preterm Infant is defined as a group of patients whose gestational age is lower than 37 weeks due to either iatrogenic reasons or maternal reasons. Preterm infant could be classified into 4 group according to gestational age: very early preterm infant, early preterm infant, midterm preterm infant, and late preterm infant. Moreover, they could be categorized into 3 groups of birth weight: extremely low birth weight, very low birth weight, and low birth weight. These varies of preterm infant are indicated to have further developmental and body-functional difficulties and lags. Under the basis of International Classification of Functioning, Disability and Health-Children and Youth Version (ICF-CY) framework, problems related to Preterm infant would further limit their activities of daily living (ADL), participation, and health related quality of life (HRQOL).
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation and qualities in their lives. Understanding knowledges of these developmental patterns of Function and Participation in Life Activities (FPLA) and HRQOL may be helpful for anticipating and managing the problems. This study hypothesizes that the course of developmental patterns in FPLA and HRQOL of preterm infant evolve with their age. The functional recovery levels include developmental function, activity, participation, and quality of life (QOL).
This study included validity and reliability study and a prospective 2 phases, 3-years period longitudinal study of patient with preterm infant. From the first half year, 50 used-to-be preterm infant children and 50 used-to-be full-term infant children will be recruited to examine the reliability and validity of assessment tools and examiner. From the late half of the 1st and following years, 100 used-to-be full-term infant children (0-3 years old) and 200 used-to-be preterm infant children will be recruited for follow up research. All participants will receive a series of FPLA and HRQOL assessments, which are based on ICF-CY framework. Examiners will select assessment tools that appropriate to participant's age. Moreover, during this prospective longitudinal study, each participant will receive FPLA and HRQOL assessments as baseline, and re-evaluation every 6-months after the first data collection point. We believe the results of this study will refine services and supports for children with preterm infant to meet these goals.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chia-Ling Chen
- Numéro de téléphone: 8148 +886-3-3281200
- E-mail: clingchen@gmail.com
Lieux d'étude
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Taoyuan, Taïwan, 333
- Chang Gung Memorial Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Children who were born before 37 weeks
- Age 0-3 y/o
- Agree to sign inform consent
Exclusion Criteria:
- Active medical condition (e.g. infection)
- Concurrent disease which affect nuerological development, such as cerebral palsy, or other disease not typically associated with preterm
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Contrôle
Nourrissons en bonne santé
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Experimental
Preterm Infants
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline general development for Healthy child and preterm infants at 6 months 1
Délai: From 6 months to 4 years
|
Bayley scales of infant and Toddler Developmentfourth edition is used to examine the body function, motor function, cognitive, language, and social behavior. (Scores from 0 to 140, higher scores mean a better outcome.) |
From 6 months to 4 years
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Change from baseline general development for Healthy child and preterm infants at 6 months 2
Délai: From 6 months to 4 years
|
Comprehensive Development Inventory for Infant and Toddlers (CDIIT) is used to examine the body function, motor function, cognitive, language, and social behavior. (Higher scores mean a better outcome.) |
From 6 months to 4 years
|
|
Change from baseline general development for Healthy child and preterm infants at 6 months 3
Délai: From 6 months to 4 years
|
Hawaii Early Learning Profile (HELP) is used to examine the regulatory/sensory orginization, motor function, cognitive, language, and social behavior, and self-help.
(Higher scores mean a better outcome.)
|
From 6 months to 4 years
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Change from baseline general development for Healthy child and preterm infants at 6 months 4
Délai: From 6 months to 4 years
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General Movements Assessment (GMA) is used to examine the motor function.
(Higher scores mean a better outcome.)
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From 6 months to 4 years
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Change from baseline functions for preterm infants at 6 months
Délai: From 6 months to 4 years
|
PREMature Infant Index(PREMII) is used to examine the respiratory support, oxygen administration, apnea, bradycardia, desaturation, thermoregulation, feeding, and weight. (Higher scores mean a better outcome.) |
From 6 months to 4 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Chia-Ling Chen, Chang Gung Memorial Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202101737B0
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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