Breast FeedingNCT02998463
Facilitating Skin-to-Skin Contact In the Postnatal Period
A study testing skin-to-skin facilitating garment in people with Breast Feeding and Body Temperature Changes, run by Birmingham City University at 2 sites in United Kingdom.
Trial summary
This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Body Temperature Changes
- What is being tested?
- skin-to-skin facilitating garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 31 Mar 2017to 20 Jun 2019
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women, non-binary and transgender participants. Aged 16+ years old. Vaginal birth, including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. Body Mass Index of 18 to 30 inclusive. Births between 37 and 42 completed weeks of pregnancy. Women without any morbidities that will significantly impair their ability to independently parent their baby.
- Women planning to give birth on the labour ward, co-located birth centre, standalone birth centre or at home.
- Born 37 to 42 completed weeks gestation. Birth weight between 2500g and 4000g . Weight at six weeks of age less than 6000g. Neonates requiring blood glucose prefeed monitoring. From birth to six weeks of age.
- Working at the National Health Service Trust hosting the research. Working through the Hospital Bank. Registered midwife through the Nursing and Midwifery Council. Working on band 5, 6 or 7. Working within the hospital setting.
Who cannot join
- Caesarean section births. High dependency Unit patients. Illiterate in English. Multiple pregnancies e.g. twins. Registered child protection concerns. Substance misusing women. Body Mass Index of less than 18 at booking appointment. Body Mass Index of more than 30 at booking appointment. Aged under 16 years old.
- Neonatal participants
- Preterm neonates (less than 37 weeks gestation). Requirement for special or intensive neonatal care. Receiving phototherapy. Receiving intravenous antibiotics. Falling growth velocity of more than 2 centiles. Aged over 6 weeks old.
- Midwifery staff participants
- Midwifery staff working in the community without rotating to the hospital wards.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Birmingham City University
Birmingham, West Midlands, B15 3TN
Sandwell and West Birmingham NHS Trust
Birmingham, West Midlands, B15 3TN
About this study
Official title: A Skin-to-Skin Contact (SSC) Facilitating Device Used Within a Mother-Infant Dyad: Exploring Its Acceptability, Usage and Effect on Health Outcomes in the Postnatal Period.
This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. The research will determine the effect a facilitating garment has in comparison to conventionally facilitated skin-to-skin contact, by measuring its effect on the baby's temperature stability, breastfeeding status and weight velocity.
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
- Breast Feeding, Body Temperature Changes
- Being tested
- skin-to-skin facilitating garment
- Keywords
- Skin-to-skin, Kangaroo Care, Kangaroo Mother Care
- Medical subject headings
- Breast Feeding, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin-to-skin facilitating garmentDevice
Also called Snuby®
Fabric garment designed to accommodate term neonates having skin-to-skin contact.
| Study group | Role | What they receive |
|---|---|---|
| Snuby® users | Experimental | This group receives the Snuby® skin-to-skin facilitating garment to use in the first six weeks following birth with their baby. The use of the Snuby® garment is participant led, and used for as long and as often as they wish in the six week period. Receives: Device: skin-to-skin facilitating garment |
| Conventional Care | No intervention | This group does not receive any intervention, and collects data on the research outcomes when having conventionally facilitated skin-to-skin contact, using a towel, blanket, or clothing as preferred. Skin-to-skin contact frequency and duration is dictated by the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal neonatal temperature
Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.
Measured: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
Secondary outcomes (5)
Breastfeeding Status
Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk. Includes a comparison to self reported antenatal infant feeding intentions.
Measured: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
Mother Infant bonding
Maternal participants will self report on their perspectives of skin-to-skin contact, and its role in the relationship bonding process between themselves and their babies.
Measured: Six weeks post birth
Neonatal Weight Velocity
Neonatal weight in grams to ensure suitable for Snuby® garment.
Measured: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
Maternal participant's perspective
Maternal participants will self-report their views on the garment's ease of use and perceived value. This will be compared to the control group reporting on the same outcomes with conventionally facilitated skin-to-skin contact.
Measured: Weekly until 6 weeks post birth
Midwifery participant's perspective
Qualitative data collection from midwifery participants, including their perspectives on skin-to-skin contact in the hospital setting, and the perceived value of the Snuby® garment.
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 posted20 Dec 2016 (estimated)
- Study start31 Mar 2017
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
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 Breast FeedingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham City University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen McIntyre, DHSci, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998463
- Sponsor's protocol ID
- Bailey /Nov /2016 /RC /0640
- Status last verified
- Jul 2019
- First submitted
- 14 Dec 2016
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charpak N, Ruiz JG. Latin American Clinical Epidemiology Network Series - Paper 9: The Kangaroo Mother Care Method: from scientific evidence generated in Colombia to worldwide practice. J Clin Epidemiol. 2017 Jun;86:125-128. doi: 10.1016/j.jclinepi.2016.05.019. Epub 2016 Oct 17.
PubMed 27765653
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Skin-to-Skin Contact (SSC) Facilitating Device Used Within a Mother-Infant Dyad: Exploring Its Acceptability, Usage and Effect on Health Outcomes in the Postnatal Period.
- ClinicalTrials.gov ID
- NCT02998463
- Acronym / sponsor ID
- Bailey /Nov /2016 /RC /0640
- Conditions
- Breast Feeding, Body Temperature Changes
- Keywords
- Skin-to-skin, Kangaroo Care, Kangaroo Mother Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Birmingham City UniversityUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. The research will determine the effect a facilitating garment has in comparison to conventionally facilitated skin-to-skin contact, by measuring its effect on the baby's temperature stability, breastfeeding status and weight velocity.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snuby® users | Experimental | Device: skin-to-skin facilitating garmentThis group receives the Snuby® skin-to-skin facilitating garment to use in the first six weeks following birth with their baby. The use of the Snuby® garment is participant led, and used for as long and as often as they wish in the six week period. |
| Conventional Care | No intervention | –This group does not receive any intervention, and collects data on the research outcomes when having conventionally facilitated skin-to-skin contact, using a towel, blanket, or clothing as preferred. Skin-to-skin contact frequency and duration is dictated by the participant. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women, non-binary and transgender participants. Aged 16+ years old. Vaginal birth, including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. Body Mass Index of 18 to 30 inclusive. Births between 37 and 42 completed weeks of pregnancy. Women without any morbidities that will significantly impair their ability to independently parent their baby.
- Women planning to give birth on the labour ward, co-located birth centre, standalone birth centre or at home.
- Born 37 to 42 completed weeks gestation. Birth weight between 2500g and 4000g . Weight at six weeks of age less than 6000g. Neonates requiring blood glucose prefeed monitoring. From birth to six weeks of age.
- Working at the National Health Service Trust hosting the research. Working through the Hospital Bank. Registered midwife through the Nursing and Midwifery Council. Working on band 5, 6 or 7. Working within the hospital setting.
Key exclusion criteria (5 listed)
- Caesarean section births. High dependency Unit patients. Illiterate in English. Multiple pregnancies e.g. twins. Registered child protection concerns. Substance misusing women. Body Mass Index of less than 18 at booking appointment. Body Mass Index of more than 30 at booking appointment. Aged under 16 years old.
- Neonatal participants
- Preterm neonates (less than 37 weeks gestation). Requirement for special or intensive neonatal care. Receiving phototherapy. Receiving intravenous antibiotics. Falling growth velocity of more than 2 centiles. Aged over 6 weeks old.
- Midwifery staff participants
- Midwifery staff working in the community without rotating to the hospital wards.
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 |
|---|---|---|
| skin-to-skin facilitating garmentAlso: Snuby®Fabric garment designed to accommodate term neonates having skin-to-skin contact. | Device | Snuby® users |
Primary outcome
Abnormal neonatal temperature
Time frame: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.
5 secondary outcomes
Breastfeeding Status
Time frame: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
Mother Infant bonding
Time frame: Six weeks post birth
Neonatal Weight Velocity
Time frame: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
Maternal participant's perspective
Time frame: Weekly until 6 weeks post birth
Midwifery participant's perspective
Time frame: 12 months post birth of the first participating mother-infant dyad.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Background: PubMed 27765653Charpak N, Ruiz JG. Latin American Clinical Epidemiology Network Series - Paper 9: The Kangaroo Mother Care Method: from scientific evidence generated in Colombia to worldwide practice. J Clin Epidemiol. 2017 Jun;86:125-128. doi: 10.1016/j.jclinepi.2016.05.019. Epub 2016 Oct 17.
- 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.
Helen McIntyre, DHSci principal investigator
University of Leicester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin-to-skin facilitating garment in people with Breast Feeding and Body Temperature Changes, run by Birmingham City University at 2 sites in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Abnormal neonatal temperature (time frame: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.). 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 NCT02998463, 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 26 Jul 2019.