Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)
17. srpna 2026 aktualizováno: 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
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Victoria Laleau, MS
- Telefonní číslo: 415-502-6266
- E-mail: victoria.laleau@ucsf.edu
Studijní místa
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Kampala, Uganda
- Makerere University School of Public Health
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Kontakt:
- Victoria Nankabirwa, PhD, MBBCh
- Telefonní číslo: 415-502-6266
- E-mail: nankabirwav@gmail.com
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Vrchní vyšetřovatel:
- Victoria Nankabirwa, PhD, MBBCh
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Komparátor placeba: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in weight-for-age z-score (WAZ)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Breastfeeding frequency
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Valerie Flaherman, MD, MPH, University of California, San Francisco
- Vrchní vyšetřovatel: Victoria Nankabirwa, PhD, MBBCh, Makerere University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. května 2027
Dokončení studie (Odhadovaný)
1. května 2027
Termíny zápisu do studia
První předloženo
12. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
17. srpna 2026
První zveřejněno (Aktuální)
19. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1R21HD117269 (Grant/smlouva NIH USA)
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