Clinical trial NCT02998463: Facilitating Skin-to-Skin Contact In the Postnatal Period
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Body Temperature Changes
Keywords: Skin-to-skin
Kangaroo Care
Kangaroo Mother Care
Lead sponsor: Birmingham City University
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 110
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Abnormal neonatal temperature
timeFrame: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
Secondary outcomes:
measure: Breastfeeding Status
timeFrame: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
measure: Mother Infant bonding
timeFrame: Six weeks post birth
measure: Neonatal Weight Velocity
timeFrame: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
measure: Maternal participant's perspective
timeFrame: Weekly until 6 weeks post birth
measure: Midwifery participant's perspective
timeFrame: 12 months post birth of the first participating mother-infant dyad.
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham City University
state: West Midlands
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham NHS Trust
state: West Midlands
Study officials:
affiliation: University of Leicester
name: Helen McIntyre, DHSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charpak N, Ruiz JG. Latin American Clinical Epidemiology Network Series - Paper 9: The Kangaroo Mother Care Method: from scientific evidence generated in Colombia to worldwide practice. J Clin Epidemiol. 2017 Jun;86:125-128. doi: 10.1016/j.jclinepi.2016.05.019. Epub 2016 Oct 17.