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Completed

NCT Number: NCT03674632

Breastfeed a Better Youngster: the BABY Study

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).

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Key information

Conditions

Breastfeeding Behavior Behavioral Symptoms Breast Feeding Breast Milk Expression Breastfeeding, Exclusive Child Behavior Feeding Behavior Infant Behavior Infant Development Psychological Stress Stress, Psychological

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Children Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation meditation tape

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Infant weight

    Time frame: 8 weeks

    Infant weight will be measured at baseline and the 8-week home visit (unit kg)

  2. Infant length

    Time frame: 8 weeks

    Infant length will be measured at baseline and the 8-week home visit (unit cm)

  3. Infant head circumference

    Time frame: 8 weeks

    Infant head circumference will be measured at baseline and the 8-week home visit (unit cm)

  4. 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.

  5. 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.

  6. 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).

  7. Composition of milk macronutrients (fat, protein, carbohydrate）

    Time frame: 10 minutes

    Measured by Mid-infrared milk analyser (unit is g/100ml)

  8. 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

  9. 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

  10. Breast milk volume at 8 weeks

    Time frame: 8 weeks

    The milk volume will be measured using the test-weighing method.

  11. 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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Beijing Children's Hospital

Registry information

Official study title

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

Acronym: BABY

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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