Facilitating Skin-to-Skin Contact In the Postnatal Period
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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West Midlands
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Birmingham、West Midlands、英国、B15 3TN
- Birmingham City University
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Birmingham、West Midlands、英国、B15 3TN
- Sandwell and West Birmingham NHS TRUST
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Snuby® users
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.
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Fabric garment designed to accommodate term neonates having skin-to-skin contact.
其他名称：
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无干预：Conventional Care
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Abnormal neonatal temperature
大体时间：Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
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Axillary temperature taken by the mother with Eco Temp Basic thermometer.
Abnormal: less than 36.5°C or more than 37.5°C.
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Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Breastfeeding Status
大体时间：Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
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Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk.
Includes a comparison to self reported antenatal infant feeding intentions.
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Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
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Mother Infant bonding
大体时间：Six weeks post birth
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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.
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Six weeks post birth
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Neonatal Weight Velocity
大体时间：At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
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Neonatal weight in grams to ensure suitable for Snuby® garment.
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At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
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Maternal participant's perspective
大体时间：Weekly until 6 weeks post birth
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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.
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Weekly until 6 weeks post birth
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Midwifery participant's perspective
大体时间：12 months post birth of the first participating mother-infant dyad.
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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.
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12 months post birth of the first participating mother-infant dyad.
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合作者和调查者
调查人员
- 首席研究员：Helen McIntyre, DHSci、University of Leicester
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
skin-to-skin facilitating garment的临床试验
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University of California, IrvineBeckman Laser Institute University of California Irvine撤销
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ArjohuntleighMagellan Medical Technology Consultants, Inc.未知
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Ablon Skin Institute Research CenterGrove Acquisition Subsidiary dba VitaMedica招聘中
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Universidade Federal de GoiasConselho Nacional de Desenvolvimento Científico e Tecnológico; Germed Pharma; Theraskin完全的
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University of BirminghamUniversity College, London; National Institute for Health Research, United Kingdom招聘中