- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674632
Breastfeed a Better Youngster: the BABY Study (BABY)
Mother-infant Signalling During Lactation Following Late Preterm and Early Term Delivery: An Investigation of Physiological, Psychological and Anthropological Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be recruited while they are in the maternity hospital. A baseline assessment will be conducted during the 1-week postpartum home visit, with another study visit at 8 weeks after delivery. After obtaining written informed consent, subjects will be randomly assigned to either the intervention arm or control conditions (standard management). Participants will be told that the aim of the study is to investigate factors that may make breastfeeding easier for mothers with a LPI and ETI, so they can breast-feed for longer. They will not be told about the randomisation until the end of the study, as this knowledge would most likely lead to mothers in the control group using some form of relaxation therapy. Background characteristics of mothers and their early feeding experiences will be recorded.
Participants can choose to complete the questionnaires on paper or online in their own time after the study visit. A breast milk sample will be collected pre-feed and infant anthropometry will be assessed by a trained nurse pre-feed at each home visit. Feed duration will be noted by the trained nurse. Stool samples of infants who were born vaginally will be collected by a trained nurse at baseline and at 8-weeks. At 3-month and 6-month postpartum, there will be a telephone contact to the participants for follow-up. Participants will be invited to complete the infant questionnaires again on paper or online in their own time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China, 100045
- Beijing Children hospital
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Beijing, China, 100192
- Zhuang Wei
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primiparous mother with singleton pregnancy who is breastfeeding her late preterm infants
- Infant is singleton born at 34 0/7-37 6/7 weeks of gestation.
- Mother and infant are generally healthy (free of serious diseases that can affect breastfeeding or nursing infant, or energy balance of the infant).
- No current involvement in other research studies that can potentially affect any of outcome measures.
Exclusion Criteria:
- Infant with serious underlying or chronic disease*
- Mothers who smoke
- Infant receiving any medication regularly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: relaxation meditation tape
Participants in this arm will be asked to use the relaxation therapy during the feed at least once a day.
Participants will be given a diary to record when it is used.
Participants will be encouraged to use the tape as often as they find it helpful.
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The tape used in this study is based on a meditation CD designed for breastfeeding mother (Menelli, 2004).
The recording will be transcribed and translated into Chinese language by a certified yoga therapist.
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No Intervention: Normal care
Participants in this arm will receive normal care from the Beijing Children Hospital
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in maternal stress from baseline to 8 weeks postpartum
Time Frame: 8 weeks
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Measurement for maternal stress will use the Cohen's Perceived Stress Scale (PSS).
The PSS is a 14-item psychological self-rating scale for measuring the perception of stress on a scale of five, from 0 (never) to 4 (very often).
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant weight
Time Frame: 8 weeks
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Infant weight will be measured at baseline and the 8-week home visit (unit kg)
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8 weeks
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Infant length
Time Frame: 8 weeks
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Infant length will be measured at baseline and the 8-week home visit (unit cm)
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8 weeks
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Infant head circumference
Time Frame: 8 weeks
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Infant head circumference will be measured at baseline and the 8-week home visit (unit cm)
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8 weeks
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Infant temperament
Time Frame: 8 weeks
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Measured using the revised Rothbart Infant Behaviour Questionnaire (RIBQ) at 2 months of age.
The RIBQ is a 7-point Likert scale, from 1 (never) to 7 (always).
Three major dimensions will be used for the assessment of infant temperament; surgency/extraversion, negative affectivity and orienting/regulation.
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8 weeks
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Infant behaviour
Time Frame: 8 weeks
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Measured by 3-day infant behaviour diary (average mins per day spent in each behavioural state).
The diary consists of a time scale for 72 hours, which is divided into 15 minutes segments, and has five categories of behaviour: Sleeping, Awake and content, Fussy, Crying and Feeding.
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8 weeks
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Infant appetite
Time Frame: 8 weeks
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Measured using the Baby Eating Behaviour Questionnaire (BEBQ) at 2 months of age.
It consists of 18 items designed to measure four traits: "enjoyment of food" (4 items), "food responsiveness" (5 items), "slowness in eating" (4 items), and satiety responsiveness" (5 items).
The mothers in this study will be asked to rate all items based on a scale from 1 (never) to 5 (always).
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8 weeks
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Composition of milk macronutrients (fat, protein, carbohydrate)
Time Frame: 10 minutes
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Measured by Mid-infrared milk analyser (unit is g/100ml)
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10 minutes
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Composition of microbiota in breastmilk samples at one week and 8-week postpartum
Time Frame: 8 weeks
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Measured using the 16S rRNA based amplicon sequencing technique
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8 weeks
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Composition of microbiota in stool samples at one week and 8-week postpartum
Time Frame: 8 weeks
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Measured using the 16S rRNA based amplicon sequencing technique
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8 weeks
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Breast milk volume at 8 weeks
Time Frame: 8 weeks
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The milk volume will be measured using the test-weighing method.
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8 weeks
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Energy content of the milk
Time Frame: 10 minutes
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The energy content will estimated from the milk volume measurement provided by Mid-infrared milk analyser in ml and kcal/100ml
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10 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary Fewtrell, PhD, University College, London
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18PE15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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