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Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study

10. august 2022 oppdatert av: Chang Gung Memorial Hospital
A Longitudinal Study of Function, ADL, and Quality of life of Patients with Developmental Disabilities

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

1000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 måneder til 3 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Enroll preterm and healthy infants.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Kontroll
Friske spedbarn
Experimental
Preterm Infants

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline general development for Healthy child and preterm infants at 6 months 1
Tidsramme: 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
Change from baseline general development for Healthy child and preterm infants at 6 months 2
Tidsramme: 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
Tidsramme: 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
Change from baseline general development for Healthy child and preterm infants at 6 months 4
Tidsramme: From 6 months to 4 years
General Movements Assessment (GMA) is used to examine the motor function. (Higher scores mean a better outcome.)
From 6 months to 4 years
Change from baseline functions for preterm infants at 6 months
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Chia-Ling Chen, Chang Gung Memorial Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

21. februar 2023

Primær fullføring (Forventet)

31. desember 2024

Studiet fullført (Forventet)

31. mars 2025

Datoer for studieregistrering

Først innsendt

17. februar 2022

Først innsendt som oppfylte QC-kriteriene

10. august 2022

Først lagt ut (Faktiske)

12. august 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. august 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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