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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03497793
Acronym
Preterm SNUBY®
Enrollment
0
Registered
2018-04-13
Start date
2021-12-31
Completion date
2021-12-31
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Premature Birth

Brief summary

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

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.

Interventions

OTHERSNUBY

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.

Sponsors

University of Birmingham
CollaboratorOTHER
University of Nottingham
CollaboratorOTHER
University Hospitals of Derby and Burton NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Days to 4 Months
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Infant's body temperature 30 minutes after starting skin-to-skin care with the SNUBY®Following 30 minutes of skin-to-skin contact.Axillary temperature of the infant taken 30 min after starting skin-to-skin care
Infant's body temperature 30 minutes after completing skin-to-skin care with the SNUBY®Following 30 minutes of skin-to-skin contact.Axillary temperature taken 30 minutes after completing skin-to-skin care
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)Following 30 minutes of skin-to-skin contact.discreet events of desaturations or bradycardia

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026