Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)
2026년 8월 17일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Victoria Laleau, MS
- 전화번호: 415-502-6266
- 이메일: victoria.laleau@ucsf.edu
연구 장소
-
-
-
Kampala, 우간다
- Makerere University School of Public Health
-
연락하다:
- Victoria Nankabirwa, PhD, MBBCh
- 전화번호: 415-502-6266
- 이메일: nankabirwav@gmail.com
-
수석 연구원:
- Victoria Nankabirwa, PhD, MBBCh
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Relaxation Audiorecording
Listening to a relaxation audiorecording twice daily on a digital audio device while breastfeeding
|
This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
|
|
위약 비교기: Control audio device
Digital audio device without a relaxation audiorecording
|
Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in weight-for-age z-score (WAZ)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Breastfeeding frequency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Valerie Flaherman, MD, MPH, University of California, San Francisco
- 수석 연구원: Victoria Nankabirwa, PhD, MBBCh, Makerere University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2027년 5월 1일
연구 완료 (추정된)
2027년 5월 1일
연구 등록 날짜
최초 제출
2026년 8월 12일
QC 기준을 충족하는 최초 제출
2026년 8월 17일
처음 게시됨 (실제)
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 17일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .