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

Study Overview
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Brief Summary
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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®.

Detailed Description
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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.

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

Conditions
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Premature Birth, Breast Feeding

Intervention / Treatment
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* Other: SNUBY


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin-to-skin care with SNUBY<br>Mothers providing skin-to-skin care with the use of SNUBY | Other: SNUBY<br>* 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.<br>|

What is the study measuring?
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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. |