- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02998463
Facilitating Skin-to-Skin Contact In the Postnatal Period
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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West Midlands
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Birmingham, West Midlands, Det Forenede Kongerige, B15 3TN
- Birmingham City University
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Birmingham, West Midlands, Det Forenede Kongerige, B15 3TN
- Sandwell and West Birmingham NHS Trust
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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Fabric garment designed to accommodate term neonates having skin-to-skin contact.
Andre navne:
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Abnormal neonatal temperature
Tidsramme: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
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Axillary temperature taken by the mother with Eco Temp Basic thermometer.
Abnormal: less than 36.5°C or more than 37.5°C.
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Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Breastfeeding Status
Tidsramme: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
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Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk.
Includes a comparison to self reported antenatal infant feeding intentions.
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Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
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Mother Infant bonding
Tidsramme: Six weeks post birth
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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.
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Six weeks post birth
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Neonatal Weight Velocity
Tidsramme: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
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Neonatal weight in grams to ensure suitable for Snuby® garment.
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At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
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Maternal participant's perspective
Tidsramme: Weekly until 6 weeks post birth
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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.
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Weekly until 6 weeks post birth
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Midwifery participant's perspective
Tidsramme: 12 months post birth of the first participating mother-infant dyad.
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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.
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12 months post birth of the first participating mother-infant dyad.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Helen McIntyre, DHSci, University of Leicester
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Bailey /Nov /2016 /RC /0640
Plan for individuelle deltagerdata (IPD)
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