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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
110
Fabric garment designed to accommodate term neonates having skin-to-skin contact.
Birmingham City University
Birmingham, West Midlands, United Kingdom
Sandwell and West Birmingham NHS Trust
Birmingham, West Midlands, United Kingdom
Abnormal neonatal temperature
Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.
Time frame: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
Breastfeeding Status
Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk. Includes a comparison to self reported antenatal infant feeding intentions.
Time frame: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
Mother Infant bonding
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.
Time frame: Six weeks post birth
Neonatal Weight Velocity
Neonatal weight in grams to ensure suitable for Snuby® garment.
Time frame: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
Maternal participant's perspective
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.
Time frame: Weekly until 6 weeks post birth
Midwifery participant's perspective
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.
Time frame: 12 months post birth of the first participating mother-infant dyad.
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