Breastfeed a Better Youngster: the BABY Study
Condition: Breastfeeding; Breastfeeding, Exclusive; Infant Behavior; Psychological Stress; Breast Milk Expression; Infant Development
MeSH terms: Stress, Psychological
Study type: Interventional

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.
    

Intervention name(s): Relaxation meditation tape
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: breastfeeding; maternal stress; infant behavior; infant development; relaxation