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Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)

17. august 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Uganda
      • Kampala, Uganda
        • Makerere University School of Public Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Victoria Nankabirwa, PhD, MBBCh

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Relaxation Audiorecording
Listening to a relaxation audiorecording twice daily on a digital audio device while breastfeeding
Atferdsmessig: Relaxation audiorecording
This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
Placebo komparator: Control audio device
Digital audio device without a relaxation audiorecording
Atferdsmessig: Control audio device without relaxation audiorecording
Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in weight-for-age z-score (WAZ)
Tidsramme: From birth through 12 weeks of age
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.
From birth through 12 weeks of age

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Breastfeeding frequency
Tidsramme: 1, 2, 4 and 12 weeks of age
Breastfeeding behavior including frequency and duration will be assessed
1, 2, 4 and 12 weeks of age
Any infant dietary intake other than human milk since last study visit
Tidsramme: 1, 2, 4 and 12 weeks of age
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.
1, 2, 4 and 12 weeks of age
Milk transfer
Tidsramme: 1, 2, 4 and 12 weeks of age
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.
1, 2, 4 and 12 weeks of age
Maternal stress
Tidsramme: 1, 2, 4 and 12 weeks of age
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.
1, 2, 4 and 12 weeks of age
Maternal anxiety
Tidsramme: 2, 4 and 12 weeks after birth
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.
2, 4 and 12 weeks after birth
Maternal depression
Tidsramme: 1, 2, 4, and 12 weeks after birth
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.
1, 2, 4, and 12 weeks after birth
sIgA
Tidsramme: 2 and 4 weeks after birth
Secretory immunoglobulin A levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
2 and 4 weeks after birth
IgG
Tidsramme: 2 and 4 weeks after birth
Immunoglobulin G levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
2 and 4 weeks after birth
Adverse events
Tidsramme: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Fingertip temperature
Tidsramme: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Heart rate
Tidsramme: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Blood pressure
Tidsramme: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Actual use of the audiorecording
Tidsramme: 1, 2, 4 and 12 weeks after enrollment
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
1, 2, 4 and 12 weeks after enrollment

Samarbeidspartnere og etterforskere

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Sponsor

University of California, San Francisco

Samarbeidspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Cornell University

Etterforskere

  • Hovedetterforsker: Valerie Flaherman, MD, MPH, University of California, San Francisco
  • Hovedetterforsker: Victoria Nankabirwa, PhD, MBBCh, Makerere University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

12. august 2026

Først innsendt som oppfylte QC-kriteriene

17. august 2026

Først lagt ut (Faktiske)

19. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1R21HD117269 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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