- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00946244
A Longitudinal Study of Effectiveness of Early Intervention for Preterm Infants
21. februar 2017 opdateret af: National Taiwan University Hospital
The main purpose of this study is to extend the investigators' previous research to longitudinally examine the effectiveness of three early intervention programs: usual care program, clinic-based intervention program and home-based intervention program for very low birth weight preterm children at 3 and 4 years of age.
Normal weight full-term children will also be included to serve as the reference group.
Effectiveness assessments will include child, parenting, and transactions measures.
Child outcome measures will include health status, growth, neurodevelopment and behavior; parenting outcome measures will include parental stress, competence, efficacy and family support; transactions outcome measure will include parent-child interaction procedures.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Accumulating data on early intervention for preterm infants illustrated short-term benefits on enhancing child development and decreasing parental stress, particularly for those of heavier birth weights.
However, rare studies had designed early intervention program for small preterm infants and longitudinally examined the effectiveness in various outcome domains.
Our research team recently conducted a clinical randomization trial on the effectiveness of three early intervention programs: usual care program (UCP), clinic-based intervention program (CBIP) and home-based intervention program (HBIP) on very low birth weight (VLBW, birth weight <1,500 g) preterm infants from the neonatal period to two years corrected age (CA).
The latter two were comprehensive, intensive intervention programs that combined child- and parent-focused services beginning in hospitalization and ending at one year CA as delivered at clinic and home respectively.
This three-year research project has extended our previous work to longitudinally examine the effectiveness of the three intervention programs in 180 VLBW preterm infants at 3 and 4 years of age.
Sixty full-term infants will also be included to serve as the reference group.
Outcome measures will include child (i.e., health, growth, neurodevelopment and behavior), parenting (i.e., parental stress, competency, efficacy and family support) and mother-child transactions (i.e., free-play and frustrating episode).
The longitudinal data on the effectiveness of these early intervention programs for VLBW preterm infants will provide important information to help early intervention professionals and public policy makers to develop effective intervention for preterm children at risk for developmental problems.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
183
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år til 4 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Term and VLBW preterm children were born at the National Taiwan University Hospital and the Mackay Memorial Hospital (MMH)
Beskrivelse
Inclusion Criteria:
- Body weight below 1501 gm
- Gestational age under 37 weeks
- Admission to the study hospitals within the first 7 days of life
- Singleton or the first child of twin or multiple births
- Physiologically stable at PCA 36 weeks as determined by attending physician
- Hospital discharge prior to PCA 44 weeks
Exclusion Criteria:
- Seizure
- Hydrocephalus
- Ventriculoperitoneal shunt
- Meningitis, periventricular leukomalacia
- Grade III to IV intraventricular hemorrhage
- Stage IV retinopathy of prematurity)
- Necrotizing enterocolitis with colostomy
- Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Term infants
Healthy term infants
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Usual care program
VLBW preterm infants who received usual medical care during hospitalization after birth
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Clinic-based intervention program
VLBW preterm infants who received specific early intervention program delivered at clinic before 1 year of corrected age (in previous study)
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Home-based intervention program
VLBW preterm infants who received specific early intervention program delivered at home before 1 year of corrected age (in previous study)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Child's development (health, growth, neurodevelopment and behavior)
Tidsramme: 3 and 4 years of age
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3 and 4 years of age
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Parenting function (parent stress, competency, efficacy and family support)
Tidsramme: 3 and 4 years of age
|
3 and 4 years of age
|
Parent-child transactions
Tidsramme: 3 and 4 years of age
|
3 and 4 years of age
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2009
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
22. juli 2009
Først indsendt, der opfyldte QC-kriterier
23. juli 2009
Først opslået (Skøn)
24. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. februar 2017
Sidst verificeret
1. november 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 200812114R
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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