Clinical trial NCT03674632: Breastfeed a Better Youngster: the BABY Study
Official title: Mother-infant Signalling During Lactation Following Late Preterm and Early Term Delivery: An Investigation of Physiological, Psychological and Anthropological Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Breastfeeding, Exclusive
Infant Behavior
Psychological Stress
Breast Milk Expression
Infant Development
Keywords: breastfeeding
maternal stress
infant behavior
infant development
relaxation
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Beijing Children's Hospital
First posted: 2018-09-17
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in maternal stress from baseline to 8 weeks postpartum
timeFrame: 8 weeks
Secondary outcomes:
measure: Infant weight
timeFrame: 8 weeks
measure: Infant length
timeFrame: 8 weeks
measure: Infant head circumference
timeFrame: 8 weeks
measure: Infant temperament
timeFrame: 8 weeks
measure: Infant behaviour
timeFrame: 8 weeks
measure: Infant appetite
timeFrame: 8 weeks
measure: Composition of milk macronutrients (fat, protein, carbohydrate）
timeFrame: 10 minutes
measure: Composition of microbiota in breastmilk samples at one week and 8-week postpartum
timeFrame: 8 weeks
measure: Composition of microbiota in stool samples at one week and 8-week postpartum
timeFrame: 8 weeks
measure: Breast milk volume at 8 weeks
timeFrame: 8 weeks
measure: Energy content of the milk
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children Hospital
city: Beijing
country: China
facility: Zhuang Wei
Study officials:
affiliation: University College, London
name: Mary Fewtrell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu J, Wells J, Wei Z, Fewtrell M. Effects of relaxation therapy on maternal psychological state, infant growth and gut microbiome: protocol for a randomised controlled trial investigating mother-infant signalling during lactation following late preterm and early term delivery. Int Breastfeed J. 2019 Dec 16;14:50. doi: 10.1186/s13006-019-0246-5. eCollection 2019.