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
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Victoria Laleau, MS
- 電話番号：415-502-6266
- メール：victoria.laleau@ucsf.edu
研究場所
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Kampala、ウガンダ
- Makerere University School of Public Health
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コンタクト：
- Victoria Nankabirwa, PhD, MBBCh
- 電話番号：415-502-6266
- メール：nankabirwav@gmail.com
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主任研究者：
- Victoria Nankabirwa, PhD, MBBCh
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in weight-for-age z-score (WAZ)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Breastfeeding frequency
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Valerie Flaherman, MD, MPH、University of California, San Francisco
- 主任研究者：Victoria Nankabirwa, PhD, MBBCh、Makerere University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2027年5月1日
研究の完了 (推定)
2027年5月1日
試験登録日
最初に提出
2026年8月12日
QC基準を満たした最初の提出物
2026年8月17日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。