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Breastfeed a Better Youngster: the BABY Study (BABY)

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ClinicalTrials.gov Identifier: NCT03674632
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Beijing Children's Hospital
Information provided by (Responsible Party):
Mary Fewtrell, University College, London

Tracking Information
First Submitted Date  ICMJE August 29, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE November 25, 2018
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
Changes in maternal stress from baseline to 8 weeks postpartum [ Time Frame: 8 weeks ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Infant weight [ Time Frame: 8 weeks ]
    Infant weight will be measured at baseline and the 8-week home visit (unit kg)
  • Infant length [ Time Frame: 8 weeks ]
    Infant length will be measured at baseline and the 8-week home visit (unit cm)
  • Infant head circumference [ Time Frame: 8 weeks ]
    Infant head circumference will be measured at baseline and the 8-week home visit (unit cm)
  • Infant temperament [ Time Frame: 8 weeks ]
    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.
  • Infant behaviour [ Time Frame: 8 weeks ]
    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.
  • Infant appetite [ Time Frame: 8 weeks ]
    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).
  • Composition of milk macronutrients (fat, protein, carbohydrate) [ Time Frame: 10 minutes ]
    Measured by Mid-infrared milk analyser (unit is g/100ml)
  • Composition of microbiota in breastmilk samples at one week and 8-week postpartum [ Time Frame: 8 weeks ]
    Measured using the 16S rRNA based amplicon sequencing technique
  • Composition of microbiota in stool samples at one week and 8-week postpartum [ Time Frame: 8 weeks ]
    Measured using the 16S rRNA based amplicon sequencing technique
  • Breast milk volume at 8 weeks [ Time Frame: 8 weeks ]
    The milk volume will be measured using the test-weighing method.
  • Energy content of the milk [ Time Frame: 10 minutes ]
    The energy content will estimated from the milk volume measurement provided by Mid-infrared milk analyser in ml and kcal/100ml
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breastfeed a Better Youngster: the BABY Study
Official Title  ICMJE Mother-infant Signalling During Lactation Following Late Preterm and Early Term Delivery: An Investigation of Physiological, Psychological and Anthropological Factors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breastfeeding
  • Breastfeeding, Exclusive
  • Infant Behavior
  • Psychological Stress
  • Breast Milk Expression
  • Infant Development
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Relaxation meditation tape
  • No Intervention: Normal care
    Participants in this arm will receive normal care from the Beijing Children Hospital
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2020
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zhuang Wei, PhD +86 13520312098 wei9zhuang@aliyun.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674632
Other Study ID Numbers  ICMJE 18PE15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The IPD will only be used in a PhD thesis and further investigations
Responsible Party Mary Fewtrell, University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Beijing Children's Hospital
Investigators  ICMJE
Principal Investigator: Mary Fewtrell, PhD University College, London
PRS Account University College, London
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP