Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)
2026年8月17日 更新者：University of California, San Francisco
Randomized Controlled Trial of a Relaxation Intervention to Improve Newborn Growth and Maternal Well-being
The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are:
- Does listening to a relaxation audiorecording during breastfeeding improve infant growth?
- Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety?
Researchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being.
Participants will:
- Listen to an audiorecording twice daily while breastfeeding for 12 weeks
- Have study visits at 1, 2, 4 and 12 weeks for checkups and tests
- Let us know what they think of the audiorecording
研究概览
地位
尚未招聘
详细说明
Infant growth impairment is common in low-income countries and greatly increases the risk of adverse infant outcomes including infectious disease and cognitive impairment.
Recently, randomized controlled trials in high-income countries have demonstrated that an audiorecording promoting relaxation during breastfeeding can improve growth for at-risk breastfeeding infants, perhaps by reducing maternal stress and improving maternal well-being.
In this application, we propose to study whether such an intervention might be efficacious in a low-income country by conducting the randomized controlled trial, "Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)," which will enroll 100 mothers and their LBW newborns hospitalized in a high-stress setting in Uganda, randomly assign them either to an audiorecording promoting relaxation during breastfeeding (intervention) or to usual care (control), and follow them at 1, 2, 4, and 12 weeks after birth to assess infant growth, adverse events, milk intake, feeding behavior, and maternal wellbeing.
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Victoria Laleau, MS
- 电话号码：415-502-6266
- 邮箱：victoria.laleau@ucsf.edu
学习地点
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Kampala、乌干达
- Makerere University School of Public Health
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接触：
- Victoria Nankabirwa, PhD, MBBCh
- 电话号码：415-502-6266
- 邮箱：nankabirwav@gmail.com
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首席研究员：
- Victoria Nankabirwa, PhD, MBBCh
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Newborn low birth weight (LBW) (birth weight < 2500 grams)
- Newborn birth weight >= 1800 g
- Newborn admitted to Neonatal Intensive Care Unit (NICU)
- Newborn in stable condition without WHO danger signs
- Newborn age <24 hours old
- Breastfeeding initiated
- Residence in the catchment area
Exclusion Criteria:
- Twins and other multiples
- Newborn respiratory support or WHO danger signs
- Newborn with major congenital anomaly or expected surgery
- Contraindications to or unable to breastfeed
- Mother with hearing impairment
- Unable to speak Luganda
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Relaxation Audiorecording
Listening to a relaxation audiorecording twice daily on a digital audio device while breastfeeding
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This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
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安慰剂比较：Control audio device
Digital audio device without a relaxation audiorecording
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Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording
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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 |
|---|---|---|
|
Change in weight-for-age z-score (WAZ)
大体时间：From birth through 12 weeks of age
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Weight will be measured with the Seca 334 Infant Scale (Seca Inc., Wandsbek, Germany), which is portable for study visits at home or in hospital or clinic and is accurate to 5 grams.
WAZ will be calculated from measured weight using the World Health Organization (WHO) Anthro Survey Analyser.
Change in WAZ will be calculated by subtracting WAZ at birth from WAZ at 12 weeks of age.
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From birth through 12 weeks of age
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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 frequency
大体时间：1, 2, 4 and 12 weeks of age
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Breastfeeding behavior including frequency and duration will be assessed
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1, 2, 4 and 12 weeks of age
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Any infant dietary intake other than human milk since last study visit
大体时间：1, 2, 4 and 12 weeks of age
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Infant receipt of any feeding other than human milk since the last study visit will be assessed.
We will query mothers about infant dietary intake since the last study visit including human breast milk, formula or any other feeding type such as juice or cow's milk.
Infants who have received only human breast milk since the last study visit will be categorized as "no" for this outcome.
Infants who have received any type of feeding other than human breast milk will be categorized as "yes" for this outcome.
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1, 2, 4 and 12 weeks of age
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Milk transfer
大体时间：1, 2, 4 and 12 weeks of age
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Milk transfer from mother to infant will be measured in grams using the Breast Milk Intake Function of the Seca 334 Infant Scale.
We will subtract the infant's pre-feeding weight (measured in grams) from the infant's post-feeding weight (measured in grams) to determine grams of milk transferred from mother to infant during the feeding.
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1, 2, 4 and 12 weeks of age
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Maternal stress
大体时间：1, 2, 4 and 12 weeks of age
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Maternal stress will be measured at birth and at 4 and 12 weeks after birth using the Perceived Stress Scale (PSS), a tool which has been validated in the Ugandan postpartum population and which assesses participant stress over the past month.
We will use the 10-item version of the PSS which has a minimum score of 0 and a maximum score of 40.
Higher scores on the PSS are associated with increased stress.
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1, 2, 4 and 12 weeks of age
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Maternal anxiety
大体时间：2, 4 and 12 weeks after birth
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Maternal anxiety will be measured at birth and at 2, 4 and 12 weeks after birth using the Generalized Anxiety Disorder 7-item scale (GAD-7), which has been validated for use in the Uganda.
The GAD-7 has a minimum score of 0 and a maximum score of 21, with higher scores indicating higher levels of anxiety.
The GAD-7 assesses participant anxiety over the past two weeks, so we will assess mothers using the GAD-7 at intervals no more frequent than 2 weeks.
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2, 4 and 12 weeks after birth
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Maternal depression
大体时间：1, 2, 4, and 12 weeks after birth
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Maternal depression will be measured at 1, 2, 4, and 12 weeks after birth using the Edinburgh Postnatal Depression Scale (EPDS).
The minimum score on the EPDS is 0 and the maximum score is 30, with higher scores indicating increased risk of depression.
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1, 2, 4, and 12 weeks after birth
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sIgA
大体时间：2 and 4 weeks after birth
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Secretory immunoglobulin A levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
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2 and 4 weeks after birth
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IgG
大体时间：2 and 4 weeks after birth
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Immunoglobulin G levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
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2 and 4 weeks after birth
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Adverse events
大体时间：1, 2, 4 and 12 weeks after birth
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Adverse events will be measured at 1, 2, 4 and 12 weeks after birth by querying participants regarding fever, difficulty feeding, difficulty breathing, cough, rash and diarrheal illness since the last study visit.
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1, 2, 4 and 12 weeks after birth
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Fingertip temperature
大体时间：1, 2, 4 and 12 weeks after birth
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For participants in the intervention group, fingertip temperature will be measured with the Gentle Temp 720 Thermometer (Omron, Inc.) before and after listening to the audiorecording intervention at each study visit.
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1, 2, 4 and 12 weeks after birth
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Heart rate
大体时间：1, 2, 4 and 12 weeks after birth
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For participants in the intervention group, heart rate will be measured with the BP7100 Series 3 (Omron, Inc.) before and after listening to the audiorecording intervention at each study visit.
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1, 2, 4 and 12 weeks after birth
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Blood pressure
大体时间：1, 2, 4 and 12 weeks after birth
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For participants in the intervention group, blood pressure will be measured with the BP7100 Series 3 (Omron, Inc.) before and after listening to the audiorecording at each study visit.
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1, 2, 4 and 12 weeks after birth
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Actual use of the audiorecording
大体时间：1, 2, 4 and 12 weeks after enrollment
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For participants in the intervention group, actual use of the audiorecording will be measured by self-report of how many times the audiorecording was used in the past 24 hours
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1, 2, 4 and 12 weeks after enrollment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Valerie Flaherman, MD, MPH、University of California, San Francisco
- 首席研究员：Victoria Nankabirwa, PhD, MBBCh、Makerere University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
- Levene I, Mohd Shukri NH, O'Brien F, Quigley MA, Fewtrell M. Relaxation Therapy and Human Milk Feeding Outcomes: A Systematic Review and Meta-Analysis. JAMA Pediatr. 2024 Jun 1;178(6):567-576. doi: 10.1001/jamapediatrics.2024.0814.
- Dib S, Wells JCK, Eaton S, Fewtrell M. A Breastfeeding Relaxation Intervention Promotes Growth in Late Preterm and Early Term Infants: Results from a Randomized Controlled Trial. Nutrients. 2022 Nov 27;14(23):5041. doi: 10.3390/nu14235041.
- Kaggwa MM, Najjuka SM, Bongomin F, Mamun MA, Griffiths MD. Prevalence of depression in Uganda: A systematic review and meta-analysis. PLoS One. 2022 Oct 20;17(10):e0276552. doi: 10.1371/journal.pone.0276552. eCollection 2022.
- Roddy Mitchell A, Gordon H, Atkinson J, Lindquist A, Walker SP, Middleton A, Tong S, Hastie R. Prevalence of Perinatal Anxiety and Related Disorders in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2023 Nov 1;6(11):e2343711. doi: 10.1001/jamanetworkopen.2023.43711.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年8月12日
首先提交符合 QC 标准的
2026年8月17日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年8月1日
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.