Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Follow Ups of Parents With Infants With Cleft Lip and Palate

22. september 2021 opdateret af: Kim Alexander Tønseth, Oslo University Hospital
In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. The purpose of this study is to investigate the effect of systematic follow ups of parents with infants with CLP performed by a special trained nurse. Parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. The control should be examined first. Both groups will answer questionnaires 3 times during the child's first year.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

145

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
      • Oslo, Norge
        • Oslo university hospital; Rikshospitalet

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate
  • Birthplace in south-east region of Norway
  • Scandinavian speaking parents

Exclusion Criteria:

  • Parents of infants with CLP who are referred to the hospital after the first measure point
  • Birthplace outside south-east region of Norway
  • Non-scandinavian speaking parents

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Arm A

Standard care consists of:

  • a phone call from a CLP-nurse after the referral from the local birth hospital has been received
  • telephone service at parents request and at the staffs availability
  • invitation to a one-day-information course before surgery
Aktiv komparator: Arm B

Systematic follow up by a special trained nurse consists of:

  • telephone contact with the parents shortly after birth
  • visit at the maternity ward within 36 hours after the referral has been received
  • telephone follow ups at specific times and at parents request
  • guidance and support in feeding and treatment
  • written information
  • cooperation with the staff at the maternity unit and the health centre
  • follow up in accordance with a check-list and log
  • invitation to a one-day-information course before surgery
Andet: Cleft lip and palate
Comparison between Arm A who will receive standard care and Arm B who will receive systematic follow up performed by a special trained nurse will be performed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Tidsramme: 1 month post partum
Both groups
1 month post partum
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
Tidsramme: 1 month post partum
Both Groups
1 month post partum
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
Tidsramme: 1 month post partum
Both groups
1 month post partum
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
Tidsramme: 1 month post partum
Both groups
1 month post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Tidsramme: 1 month post partum
Both groups
1 month post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Tidsramme: 6 months post partum
Both groups
6 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Tidsramme: 6 months post partum
Both groups
6 months post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Tidsramme: 13 months post partum
Both groups
13 months post partum
Infant growth as measured by "Child health card"
Tidsramme: 13 months post partum
Both groups
13 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Tidsramme: 13 months post partum
Both groups
13 months post partum
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
Tidsramme: 6 months post partum
Both groups
6 months post partum

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oslo University Hospital

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 (Faktiske)

1. april 2015

Primær færdiggørelse (Faktiske)

1. januar 2019

Studieafslutning (Faktiske)

1. januar 2019

Datoer for studieregistrering

Først indsendt

27. februar 2015

Først indsendt, der opfyldte QC-kriterier

8. april 2015

Først opslået (Skøn)

14. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014/17828

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 .

Kliniske forsøg med Ganespalte

Kliniske forsøg med Cleft lip and palate

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Hungary

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner