A Feasibility Study of the SNUBY®, a Skin-to-skin Garment, in the Preterm Infant (Preterm SNUBY®)

Skin-to-skin care (placing the nappy-clad baby on the mother's bare chest and draping both in a blanket) is known to benefit both baby and mother. Benefits to the baby include warmth, reduced crying, and stabilisation of heart rate, breathing and blood sugar, and promotion of breastfeeding while simultaneously reduces mother's anxiety, improves bonding, and increases breastmilk production. Although these benefits are even more pronounced for preterm, studies show most preterm babies do not receive adequate skin-to-skin care due to fears such as dislodging intravenous lines, ventilation tubes, monitor wires and concerns about safety and privacy. Measures are therefore required to increase maternal confidence and awareness and facilitate skin-to-skin care for preterm infants.

SNUBY® (SNUggle baBY) is a purpose-built garment for facilitation of skin-to-skin care in preterm infants. It is made of comfortable, breathable bamboo fabric with an attractive appearance such that it can be worn as a normal garment.

In addition, it has distinctive features that allow the baby to be placed in a specially designed pouch, in direct contact with the mother's skin, with supports for lines and tubes that may be attached to the baby. Although many garments are commercially available for mothers to carry babies, no such specially designed garment has ever been tested scientifically and none are specifically designed for preterm babies. In this observational study, the investigators will initially test the feasibility of using the SNUBY® in preterm infants by inviting five mothers-preterm infant pairs, with mother's written informed consent, to use the garment under direct supervision. Following this, the investigators will analyse the safety and acceptability of using it on a larger scale to facilitate skin-to-skin care in preterm babies. The investigators will gather information on the staff and mothers' knowledge of skin-to-skin care and their experience of using SNUBY®.

Study Overview

• Status: Withdrawn
• Conditions: Premature Birth; Breast Feeding
• Intervention / Treatment: Other: SNUBY

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm (born at < 37 weeks gestation) infants
• Admitted to the Neonatal Intensive Care Unit
• Well enough to receive skin-to-skin care
• Mothers who agree to participate AND Mothers of eligible preterm infants

Exclusion Criteria:

*Any infant or mother considered unsuitable for skin-to-skin care for medical reasons (as decided by the attending Consultant Neonatologist).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Skin-to-skin care with SNUBY; Mothers providing skin-to-skin care with the use of SNUBY

Other: SNUBY; Following written informed consent, mother will be issued with an appropriate sized SNUBY® for her use only. The infant will be placed in skin-to-skin in SNUBY®, infant chest to mother's chest whilst the mother is seated on a reclining chair, allowing the infant to be further stabilised by gravity. Monitor wires, IV lines and/or ventilation tube will be secured using the ties on the SNUBY®. The infant's temperature, pulse and SaO2 will be recorded prior to skin-to-skin, repeated as required for the infant's clinical condition or at 30min intervals for the duration of skin-to-skin. Maternal and infant behaviour will be recorded, including spontaneous breastfeeding. The time taken to put the infant into skin-to-skin care, time in skin-to-skin care and time to return to cot will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant's body temperature 30 minutes after starting skin-to-skin care with the SNUBY®	Axillary temperature of the infant taken 30 min after starting skin-to-skin care	Following 30 minutes of skin-to-skin contact.
Infant's body temperature 30 minutes after completing skin-to-skin care with the SNUBY®	Axillary temperature taken 30 minutes after completing skin-to-skin care	Following 30 minutes of skin-to-skin contact.
Number of episodes of desaturations (oxygen saturation levels below the cut off for infant's gestational age and postnatal age) and/or bradycardia (heart rate <100 beats per minute)	discreet events of desaturations or bradycardia	Following 30 minutes of skin-to-skin contact.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother's acceptability of the SNUBY®	assessed by a five point Likert scale/visual analogue scale	Six weeks post birth.
Mother's comfort level while using SNUBY®	assessed by a five point Likert scale/visual analogue scale	Six weeks post birth.
Neonatal staff's acceptability of the SNUBY®	assessed by a five point Likert scale/visual analogue scale	12 months post birth of the first participating mother-infant dyad.
Neonatal staff's ease of facilitating skin-to-skin care with SNUBY®	assessed by a five point Likert scale/visual analogue scale	12 months post birth of the first participating mother-infant dyad.

Collaborators and Investigators

• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
• Collaborators: University of Nottingham; University of Birmingham
• Investigators: Principal Investigator: Shalini Ojha, Royal Derby Hosptial

Publications and helpful links

General Publications

• 1. WHO. Preterm birth. Secondary Preterm birth 2016. http://www.who.int/mediacentre/factsheets/fs363/en/. 2. ONS. Birth Charactersitics. Secondary Birth Charactersitics 2016. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/livebirths/datasets/birthcharacteristicsinenglandandwales. 3. Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev 2016(8):CD002771. 4. Engmann C, Wall S, Darmstadt G, et al. Consensus on kangaroo mother care acceleration. Lancet 2013;382(9907):e26-7. 5. Seidman G, Unnikrishnan S, Kenny E, et al. Barriers and Enablers of Kangaroo Mother Care Practice: A Systematic Review. Plos One 2015;10(5).

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: DHRD/2017/097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No