A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
22. august 2018 oppdatert av: National Taiwan University Hospital
Four hypotheses will be tested in this study:
- The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period.
- The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group.
- Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants.
- Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group.
Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family).
The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development.
In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses.
The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.
Studietype
Intervensjonell
Registrering (Faktiske)
275
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Taipei, Taiwan, 104
- Mackay Memorial Hospital
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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
Ikke eldre enn 8 måneder (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- birth body weight < 1500 grams
- gestational age < 37 weeks
- parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi
Exclusion Criteria:
- severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC)
- congenital or chromosome abnormality
- mother < 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol, and drug)
Terminated Criteria:
- diagnosis of brain injury (e.g., PVL, stage IV ROP or greater)
- severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge
- hospital discharge beyond 44 weeks' post-menstrual age.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Family-centered intervention program
FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
|
This program was in-hospital intervention, after-discharge intervention, and neonatal follow-up.
Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation.
The 7-session after-discharge intervention consisted of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education
Andre navn:
|
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Annen: Usual care intervention program
UCP: family members were invited to present at least one session of the 5 in-hospital intervention session.
Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
|
This program was in-hospital intervention, after-discharge consultation, and neonatal follow-up.
Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation.
The after-discharge service was provided 7-phone calls for the general health consultation.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Child: neurodevelopment functions (cognition, language and motor)
Tidsramme: 24 months of corrected age
|
Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition
|
24 months of corrected age
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of neurodevelopment functions (motor) from baseline
Tidsramme: 0 months of corrected age
|
The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version
|
0 months of corrected age
|
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Child: neurodevelopment functions (behavior)
Tidsramme: 24 months of corrected age
|
Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version
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24 months of corrected age
|
|
Change of neurodevelopment functions (cognition, language and motor) from baseline
Tidsramme: 6,12, and 24 months
|
Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version
|
6,12, and 24 months
|
|
Parental functions and change from baseline (pressure)
Tidsramme: 0, 6, 12, 18, and 24 months of corrected age
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Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version
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0, 6, 12, 18, and 24 months of corrected age
|
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Parental functions and change from baseline (Quality of Life)
Tidsramme: 0, 6, 12, 18, and 24 months of corrected age
|
World Health Organization Quality of Life- Brief Taiwan version
|
0, 6, 12, 18, and 24 months of corrected age
|
|
Transactional functions and change from baseline
Tidsramme: 6, 12, and 18 months of corrected age
|
Mother-infant interaction in free play at 6, 12, and 18 months of corrected age
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6, 12, and 18 months of corrected age
|
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Transactional functions and change from baseline
Tidsramme: 6 and 12 months of corrected age
|
Wakeful Position Questionnaire at 6 and 12 months of corrected age
|
6 and 12 months of corrected age
|
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Transactions function: affordance
Tidsramme: 18 months of corrected age
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1. Affordances in the Home Environment Motor Development- Chinese version
|
18 months of corrected age
|
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Child: Medical data
Tidsramme: Birth to 24 months of corrected age
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Chart review
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Birth to 24 months of corrected age
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Child: growth data and change from baseline
Tidsramme: 0, 1, 4, 6, 12, 18, and 24 months of corrected age
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Chart review and measurement
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0, 1, 4, 6, 12, 18, and 24 months of corrected age
|
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Child: neurophysiological functions and change from baseline
Tidsramme: 1 and 4 months of corrected age
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Electroencephalogram/event-related potential
|
1 and 4 months of corrected age
|
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Child: genotyping and gene expression
Tidsramme: 0 month of corrected age
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Buccal cell collection
|
0 month of corrected age
|
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Parental adherence to Intervention
Tidsramme: 32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months
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Only assessed in FCIP group
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32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months
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Samarbeidspartnere og etterforskere
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Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Li SJ, Tsao PN, Tu YK, Hsieh WS, Yao NJ, Wu YT, Jeng SF. Cognitive and motor development in preterm children from 6 to 36 months of age: Trajectories, risk factors and predictability. Early Hum Dev. 2022 Sep;172:105634. doi: 10.1016/j.earlhumdev.2022.105634. Epub 2022 Jul 28.
- Yu YT, Huang WC, Hsieh WS, Chang JH, Lin CH, Hsieh S, Lu L, Yao NJ, Fan PC, Lee CL, Tu YK, Jeng SF. Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial. Phys Ther. 2019 Dec 16;99(12):1690-1702. doi: 10.1093/ptj/pzz120.
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 (Faktiske)
22. mai 2012
Primær fullføring (Faktiske)
10. januar 2017
Studiet fullført (Faktiske)
10. januar 2017
Datoer for studieregistrering
Først innsendt
29. januar 2013
Først innsendt som oppfylte QC-kriteriene
6. mars 2013
Først lagt ut (Anslag)
8. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. august 2018
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201103075RB
Plan for individuelle deltakerdata (IPD)
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NEI
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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