NCT03674632

Breastfeed a Better Youngster: the BABY Study

Mother-infant Signalling During Lactation Following Late Preterm and Early Term Delivery: An Investigation of Physiological, Psychological and Anthropological Factors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breastfeeding
• Breastfeeding, Exclusive
• Infant Behavior
• Psychological Stress
• Breast Milk Expression
• Infant Development

Interventions

Type	Name	Description
BEHAVIORAL	Relaxation meditation tape	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.

Timeline

• Start date: 2018-11-25
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2018-09-17
• Last updated: 2020-11-04

Locations

2 sites across 1 country: China