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Facilitating Skin-to-Skin Contact In the Postnatal Period

25. juli 2019 oppdatert av: Birmingham City University

A Skin-to-Skin Contact (SSC) Facilitating Device Used Within a Mother-Infant Dyad: Exploring Its Acceptability, Usage and Effect on Health Outcomes in the Postnatal Period.

This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. The research will determine the effect a facilitating garment has in comparison to conventionally facilitated skin-to-skin contact, by measuring its effect on the baby's temperature stability, breastfeeding status and weight velocity.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Skin-to-skin contact is used as part of a package of Kangaroo Mother Care across the world. This has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for low birth weight and preterm infants (Charpak and Ruiz 2016).

This study examines the effect a facilitating garment, the Snuby® has on neonatal health outcomes associated with skin-to-skin contact, such as neonatal thermoregulation, breastfeeding status, and self-reported mother-infant bonding. It uses a mixed methods approach to address quantitative and qualitative outcomes including participant's perspectives, and measurable health markers.

Studietype

Intervensjonell

Registrering (Faktiske)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Storbritannia
    • West Midlands
      • Birmingham, West Midlands, Storbritannia, B15 3TN
        • Birmingham City University
      • Birmingham, West Midlands, Storbritannia, B15 3TN
        • Sandwell and West Birmingham NHS TRUST

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

16 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Maternal participants

Inclusion Criteria:

Women, non-binary and transgender participants. Aged 16+ years old. Vaginal birth, including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. Body Mass Index of 18 to 30 inclusive. Births between 37 and 42 completed weeks of pregnancy. Women without any morbidities that will significantly impair their ability to independently parent their baby.

Women planning to give birth on the labour ward, co-located birth centre, standalone birth centre or at home.

Exclusion Criteria:

Caesarean section births. High dependency Unit patients. Illiterate in English. Multiple pregnancies e.g. twins. Registered child protection concerns. Substance misusing women. Body Mass Index of less than 18 at booking appointment. Body Mass Index of more than 30 at booking appointment. Aged under 16 years old.

Neonatal participants

Inclusion criteria:

Born 37 to 42 completed weeks gestation. Birth weight between 2500g and 4000g . Weight at six weeks of age less than 6000g. Neonates requiring blood glucose prefeed monitoring. From birth to six weeks of age.

Exclusion criteria:

Preterm neonates (less than 37 weeks gestation). Requirement for special or intensive neonatal care. Receiving phototherapy. Receiving intravenous antibiotics. Falling growth velocity of more than 2 centiles. Aged over 6 weeks old.

Midwifery staff participants

Inclusion Criteria:

Working at the National Health Service Trust hosting the research. Working through the Hospital Bank. Registered midwife through the Nursing and Midwifery Council. Working on band 5, 6 or 7. Working within the hospital setting.

Exclusion Criteria:

Midwifery staff working in the community without rotating to the hospital wards.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Snuby® users
This group receives the Snuby® skin-to-skin facilitating garment to use in the first six weeks following birth with their baby. The use of the Snuby® garment is participant led, and used for as long and as often as they wish in the six week period.
Enhet: skin-to-skin facilitating garment
Fabric garment designed to accommodate term neonates having skin-to-skin contact.
Andre navn:
  • Snuby®
Ingen inngripen: Conventional Care
This group does not receive any intervention, and collects data on the research outcomes when having conventionally facilitated skin-to-skin contact, using a towel, blanket, or clothing as preferred. Skin-to-skin contact frequency and duration is dictated by the participant.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Abnormal neonatal temperature
Tidsramme: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.
Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Breastfeeding Status
Tidsramme: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk. Includes a comparison to self reported antenatal infant feeding intentions.
Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
Mother Infant bonding
Tidsramme: Six weeks post birth
Maternal participants will self report on their perspectives of skin-to-skin contact, and its role in the relationship bonding process between themselves and their babies.
Six weeks post birth
Neonatal Weight Velocity
Tidsramme: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
Neonatal weight in grams to ensure suitable for Snuby® garment.
At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
Maternal participant's perspective
Tidsramme: Weekly until 6 weeks post birth
Maternal participants will self-report their views on the garment's ease of use and perceived value. This will be compared to the control group reporting on the same outcomes with conventionally facilitated skin-to-skin contact.
Weekly until 6 weeks post birth
Midwifery participant's perspective
Tidsramme: 12 months post birth of the first participating mother-infant dyad.
Qualitative data collection from midwifery participants, including their perspectives on skin-to-skin contact in the hospital setting, and the perceived value of the Snuby® garment.
12 months post birth of the first participating mother-infant dyad.

Samarbeidspartnere og etterforskere

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

Sponsor

Birmingham City University

Etterforskere

  • Hovedetterforsker: Helen McIntyre, DHSci, University of Leicester

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

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)

31. mars 2017

Primær fullføring (Faktiske)

20. juni 2019

Studiet fullført (Faktiske)

20. juni 2019

Datoer for studieregistrering

Først innsendt

14. desember 2016

Først innsendt som oppfylte QC-kriteriene

16. desember 2016

Først lagt ut (Anslag)

20. desember 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Bailey /Nov /2016 /RC /0640

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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