An interventional study of SNUBY in Premature Birth and Breast Feeding, sponsored by University Hospitals of Derby and Burton NHS Foundation Trust. Withdrawn. Open to participants aged 0 Days to 4 Months. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by University Hospitals of Derby and Burton NHS Foundation Trust · Not applicable, Interventional, and Treatment
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®.
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.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
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Exclusion Criteria:
*Any infant or mother considered unsuitable for skin-to-skin care for medical reasons (as decided by the attending Consultant Neonatologist).
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.
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
Time frame: 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
Time frame: 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
Time frame: Following 30 minutes of skin-to-skin contact.
Mother's acceptability of the SNUBY®
assessed by a five point Likert scale/visual analogue scale
Time frame: Six weeks post birth.
Mother's comfort level while using SNUBY®
assessed by a five point Likert scale/visual analogue scale
Time frame: Six weeks post birth.
Neonatal staff's acceptability of the SNUBY®
assessed by a five point Likert scale/visual analogue scale
Time frame: 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
Time frame: 12 months post birth of the first participating mother-infant dyad.
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2021; primary completion for Dec 2021, 0 months later.
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This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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University Hospitals of Derby and Burton NHS Foundation Trust