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NCT Number: NCT02998463

Facilitating Skin-to-Skin Contact In the Postnatal Period

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.

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Key information

Conditions

Breast Feeding Behavior Body Temperature Changes Feeding Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham City University, Birmingham, West Midlands, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

skin-to-skin facilitating garment

Device

Fabric garment designed to accommodate term neonates having skin-to-skin contact.

Other names: Snuby®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Birmingham City University

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2016
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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