Facilitating Skin-to-Skin Contact In the Postnatal Period

NCT02998463 | Completed

• 1 other identifier: Bailey /Nov /2016 /RC /0640
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Feeding; Body Temperature Changes

Keywords

Skin-to-skin; Kangaroo Care; Kangaroo Mother Care

Outcome Measures

Primary Outcomes (1)

• 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.

  Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.

Secondary Outcomes (5)

• Breastfeeding Status

  Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.

• Mother Infant bonding

  Six weeks post birth

• Neonatal Weight Velocity

  At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.

• Maternal participant's perspective

  Weekly until 6 weeks post birth

• Midwifery participant's perspective

  12 months post birth of the first participating mother-infant dyad.

Study Arms (2)

Snuby® users

EXPERIMENTAL

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

Conventional Care

NO INTERVENTION

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.

Interventions

skin-to-skin facilitating garment DEVICE

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

Also known as: Snuby®

Snuby® users

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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
• 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.
• Midwifery staff working in the community without rotating to the hospital wards.

Sponsors & Collaborators

• Birmingham City University: lead

Study Sites (2)

Birmingham City University

Birmingham, West Midlands, B15 3TN, United Kingdom

Location

Sandwell and West Birmingham NHS Trust

Birmingham, West Midlands, B15 3TN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27765653 BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Body Temperature Changes

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen McIntyre, DHSci

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 20, 2016
• Study Start: March 31, 2017
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)