An interventional study of skin-to-skin facilitating garment in Breast Feeding and Body Temperature Changes, sponsored by Birmingham City University. Completed at 2 sites in United Kingdom. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Birmingham City University · Not applicable, Interventional, and Other
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.
93 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 110 is above the median of 38 across 64 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →Birmingham City University is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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.
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.
Device: skin-to-skin facilitating garment
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.
Fabric garment designed to accommodate term neonates having skin-to-skin contact.
Also known as: Snuby®
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.
Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Birmingham City University