Breastfeeding Clinical Trial
— BABYOfficial title:
Mother-infant Signalling During Lactation Following Late Preterm and Early Term Delivery: An Investigation of Physiological, Psychological and Anthropological Factors
Verified date | November 2020 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research will investigate different aspects of the 'signalling' between mother and infant during breastfeeding in a stressful situation following late preterm and early term delivery, when breastfeeding is often challenging. The researcher will conduct a single-blinded randomised controlled trial in Chinese mothers who deliver a late preterm infant (LPI; 34 0/7-36 6/7 weeks of gestation) and mothers who deliver a early term infant (ETI; 37 0/7-37 6/7) and plan to exclusively breast-feed.This study will investigate the role of the milk and infant gut microbiome as a potential 'signal' in this process. A relaxation intervention (meditation tape) will be used to reduce stress levels in mothers who are expressing breast-milk or breastfeeding their infant (born at 34 0/7-37 6/7 weeks completed gestation). This study will investigate whether lower levels of stress in the mother result in more successful and effective breastfeeding, leading to improved infant outcomes (better growth, longer sleep duration and reduced crying).
Status | Completed |
Enrollment | 96 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Children Hospital | Beijing | |
China | Zhuang Wei | Beijing |
Lead Sponsor | Collaborator |
---|---|
University College, London | Beijing Children's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in maternal stress from baseline to 8 weeks postpartum | 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). | 8 weeks | |
Secondary | Infant weight | Infant weight will be measured at baseline and the 8-week home visit (unit kg) | 8 weeks | |
Secondary | Infant length | Infant length will be measured at baseline and the 8-week home visit (unit cm) | 8 weeks | |
Secondary | Infant head circumference | Infant head circumference will be measured at baseline and the 8-week home visit (unit cm) | 8 weeks | |
Secondary | Infant temperament | 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. | 8 weeks | |
Secondary | Infant behaviour | 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. | 8 weeks | |
Secondary | Infant appetite | 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). | 8 weeks | |
Secondary | Composition of milk macronutrients (fat, protein, carbohydrate) | Measured by Mid-infrared milk analyser (unit is g/100ml) | 10 minutes | |
Secondary | Composition of microbiota in breastmilk samples at one week and 8-week postpartum | Measured using the 16S rRNA based amplicon sequencing technique | 8 weeks | |
Secondary | Composition of microbiota in stool samples at one week and 8-week postpartum | Measured using the 16S rRNA based amplicon sequencing technique | 8 weeks | |
Secondary | Breast milk volume at 8 weeks | The milk volume will be measured using the test-weighing method. | 8 weeks | |
Secondary | Energy content of the milk | The energy content will estimated from the milk volume measurement provided by Mid-infrared milk analyser in ml and kcal/100ml | 10 minutes |
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