Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)
17 de agosto de 2026 atualizado por: 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
Visão geral do estudo
Status
Ainda não está recrutando
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Victoria Laleau, MS
- Número de telefone: 415-502-6266
- E-mail: victoria.laleau@ucsf.edu
Locais de estudo
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Kampala, Uganda
- Makerere University School of Public Health
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Contato:
- Victoria Nankabirwa, PhD, MBBCh
- Número de telefone: 415-502-6266
- E-mail: nankabirwav@gmail.com
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Investigador principal:
- Victoria Nankabirwa, PhD, MBBCh
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in weight-for-age z-score (WAZ)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Breastfeeding frequency
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Valerie Flaherman, MD, MPH, University of California, San Francisco
- Investigador principal: Victoria Nankabirwa, PhD, MBBCh, Makerere University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de maio de 2027
Conclusão do estudo (Estimado)
1 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
12 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de agosto de 2026
Primeira postagem (Real)
19 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R21HD117269 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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