Breast Feeding Clinical Trial
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.
Verified date | July 2019 |
Source | Birmingham City University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | June 20, 2019 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
Maternal participants Inclusion Criteria: 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. Exclusion Criteria: 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 Inclusion criteria: 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. Exclusion criteria: 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 Inclusion Criteria: 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. Exclusion Criteria: Midwifery staff working in the community without rotating to the hospital wards. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham City University | Birmingham | West Midlands |
United Kingdom | Sandwell and West Birmingham NHS Trust | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
Birmingham City University |
United Kingdom,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups. | |
Secondary | 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. | Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal. | |
Secondary | 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. | Six weeks post birth | |
Secondary | Neonatal Weight Velocity | Neonatal weight in grams to ensure suitable for Snuby® garment. | At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth. | |
Secondary | 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. | Weekly until 6 weeks post birth | |
Secondary | 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. | 12 months post birth of the first participating mother-infant dyad. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04487418 -
Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
|
N/A | |
Completed |
NCT03334266 -
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
|
N/A | |
Enrolling by invitation |
NCT02687685 -
Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)
|
N/A | |
Completed |
NCT02913638 -
A Post Breastfeeding Follow-Up Study
|
N/A | |
Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
N/A | |
Completed |
NCT03033459 -
Prenatal Lactation-Focused Motivational Interviewing
|
N/A | |
Not yet recruiting |
NCT05846828 -
Cognitive Functions in Breastfed Preschool Children
|
||
Completed |
NCT05944471 -
The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk
|
N/A | |
Completed |
NCT05629403 -
Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
|
||
Completed |
NCT04024865 -
Domperidone and Risk of Serious Cardiac Events in Postpartum Women
|
||
Recruiting |
NCT05560750 -
Lingual Frenulum in Newborn Infants (LINNE)
|
N/A | |
Completed |
NCT03232762 -
Effects of Diet on Pregnancy Outcome and Child Obesity
|
N/A | |
Recruiting |
NCT02186613 -
Telephone Support From Primary Care for Breastfeeding Mothers
|
N/A | |
Completed |
NCT01687634 -
Home Visiting for Low Income, Pregnant Women
|
N/A | |
Completed |
NCT01459991 -
The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
|
N/A | |
Completed |
NCT03574766 -
Meditation for NICU Moms
|
N/A | |
Recruiting |
NCT03945474 -
Osteopathic Manipulation in Breastfed Newborns
|
N/A | |
Recruiting |
NCT06107933 -
Developmental Impacts of Microplastics Exposure in Early Life
|
||
Not yet recruiting |
NCT05059574 -
Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies
|
N/A | |
Completed |
NCT04578925 -
Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
|
N/A |