Clinical Trial: Facilitating Skin-to-Skin Contact In the Postnatal Period

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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.

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Birmingham City University

Current Primary Outcome: Abnormal neonatal temperature [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Breastfeeding Status [ Time Frame: 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.
  • Mother Infant bonding [ Time Frame: 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.
  • Neonatal Weight Velocity [ Time Frame: 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.
  • Maternal participant's perspective [ Time Frame: 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.
  • Midwifery participant's perspective [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Birmingham City University

Dates:
Date Received: December 14, 2016
Date Started: February 2017
Date Completion: February 2020
Last Updated: December 16, 2016
Last Verified: December 2016