AzTrials
AzTrials

BreastfeedingBABYNCT03674632

Breastfeed a Better Youngster: the BABY Study

A study testing Relaxation meditation tape in people with Breastfeeding and Breastfeeding, Exclusive, run by University College, London at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Relaxation meditation tape
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
2 sitesChina
Study dates
25 Nov 2018to 31 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Infant with serious underlying or chronic disease*
  • Mothers who smoke
  • Infant receiving any medication regularly

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Children Hospital

    Beijing, 100045

  • Zhuang Wei

    Beijing, 100192

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Relaxation meditation tape
Keywords
breastfeeding, maternal stress, infant behavior, infant development, relaxation
Medical subject headings
Breast Feeding, Infant Behavior, Stress, Psychological, Breast Milk Expression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relaxation meditation tapeBehavioural

    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 groups in NCT03674632
Study groupRoleWhat they receive
relaxation meditation tapeExperimentalParticipants 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.
Receives: Behavioral: Relaxation meditation tape
Normal careNo interventionParticipants in this arm will receive normal care from the Beijing Children Hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in maternal stress from baseline to 8 weeks postpartum

    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).

    Measured: 8 weeks

Secondary outcomes (11)

  1. Infant weight

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

    Measured: 8 weeks

  2. Infant length

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

    Measured: 8 weeks

  3. Infant head circumference

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

    Measured: 8 weeks

  4. Infant temperament

    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.

    Measured: 8 weeks

  5. Infant behaviour

    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.

    Measured: 8 weeks

  6. Infant appetite

    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).

    Measured: 8 weeks

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

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

    Measured: 10 minutes

  8. Composition of microbiota in breastmilk samples at one week and 8-week postpartum

    Measured using the 16S rRNA based amplicon sequencing technique

    Measured: 8 weeks

  9. Composition of microbiota in stool samples at one week and 8-week postpartum

    Measured using the 16S rRNA based amplicon sequencing technique

    Measured: 8 weeks

  10. Breast milk volume at 8 weeks

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

    Measured: 8 weeks

  11. Energy content of the milk

    The energy content will estimated from the milk volume measurement provided by Mid-infrared milk analyser in ml and kcal/100ml

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2018
  2. Study start25 Nov 2018
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03674632
Sponsor's protocol ID
18PE15
Acronym
BABY
Status last verified
Nov 2020
First submitted
29 Aug 2018
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD will only be used in a PhD thesis and further investigations

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.

    PubMed 31889973

Questions about this trial

What is this clinical trial studying?

A study testing Relaxation meditation tape in people with Breastfeeding and Breastfeeding, Exclusive, run by University College, London at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in maternal stress from baseline to 8 weeks postpartum (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03674632, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in