Premature BirthPreterm SNUBY®NCT03497793
A Feasibility Study of the SNUBY®, a Skin-to-skin Garment, in the Preterm Infant
A study testing SNUBY in people with Premature Birth and Breast Feeding, run by University Hospitals of Derby and Burton NHS Foundation Trust.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 4 months
- Conditions the study is for
- Premature Birth, Breast Feeding
- What is being tested?
- SNUBY
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Any infant or mother considered unsuitable for skin-to-skin care for medical reasons (as decided by the attending Consultant Neonatologist).
About this study
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®.
Read the 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.
- Conditions
- Premature Birth, Breast Feeding
- Being tested
- SNUBY
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNUBYOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin-to-skin care with SNUBY | Experimental | Mothers providing skin-to-skin care with the use of SNUBY Receives: Other: SNUBY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Following 30 minutes of skin-to-skin contact.
Secondary outcomes (4)
Mother's acceptability of the SNUBY®
assessed by a five point Likert scale/visual analogue scale
Measured: Six weeks post birth.
Mother's comfort level while using SNUBY®
assessed by a five point Likert scale/visual analogue scale
Measured: Six weeks post birth.
Neonatal staff's acceptability of the SNUBY®
assessed by a five point Likert scale/visual analogue scale
Measured: 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
Measured: 12 months post birth of the first participating mother-infant dyad.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study startDec 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Contractual issues have halted study set up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Shalini Ojha, Principal investigator, Royal Derby Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497793
- Sponsor's protocol ID
- DHRD/2017/097
- Acronym
- Preterm SNUBY®
- Status last verified
- Jan 2021
- First submitted
- 16 Mar 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the SNUBY®, a Skin-to-skin Garment, in the Preterm Infant
- ClinicalTrials.gov ID
- NCT03497793
- Acronym / sponsor ID
- Preterm SNUBY® / DHRD/2017/097
- Conditions
- Premature Birth, Breast Feeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contractual issues have halted study set up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Birmingham, University of Nottingham
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin-to-skin care with SNUBY | Experimental | Other: SNUBYMothers providing skin-to-skin care with the use of SNUBY |
Who may qualify
- Ages
- 0 days to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any infant or mother considered unsuitable for skin-to-skin care for medical reasons (as decided by the attending Consultant Neonatologist).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNUBYFollowing 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. | Other | Skin-to-skin care with SNUBY |
Primary outcome
Infant's body temperature 30 minutes after starting skin-to-skin care with the SNUBY®
Time frame: 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®
Time frame: 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)
Time frame: Following 30 minutes of skin-to-skin contact.
discreet events of desaturations or bradycardia
4 secondary outcomes
Mother's acceptability of the SNUBY®
Time frame: Six weeks post birth.
Mother's comfort level while using SNUBY®
Time frame: Six weeks post birth.
Neonatal staff's acceptability of the SNUBY®
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®
Time frame: 12 months post birth of the first participating mother-infant dyad.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background1. 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).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Ojha principal investigator
Royal Derby Hosptial
Questions about this trial
What is this clinical trial studying?
A study testing SNUBY in people with Premature Birth and Breast Feeding, run by University Hospitals of Derby and Burton NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant's body temperature 30 minutes after starting skin-to-skin care with the SNUBY® (time frame: Following 30 minutes of skin-to-skin contact.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.