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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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West Midlands
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Birmingham, West Midlands, Reino Unido, B15 3TN
- Birmingham City University
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Birmingham, West Midlands, Reino Unido, B15 3TN
- Sandwell and West Birmingham NHS Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
Otros nombres:
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Abnormal neonatal temperature
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Breastfeeding Status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Helen McIntyre, DHSci, University of Leicester
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Bailey /Nov /2016 /RC /0640
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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