NCT03674632

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

August 29, 2018

Last Update Submit

November 3, 2020

Conditions

BreastfeedingBreastfeeding, ExclusiveInfant BehaviorPsychological StressBreast Milk ExpressionInfant Development

Keywords

breastfeedingmaternal stressinfant behaviorinfant developmentrelaxation

Outcome Measures

Primary Outcomes (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).

    8 weeks

Secondary Outcomes (11)

  • Infant weight

    8 weeks

  • Infant length

    8 weeks

  • Infant head circumference

    8 weeks

  • Infant temperament

    8 weeks

  • Infant behaviour

    8 weeks

  • +6 more secondary outcomes

Study Arms (2)

relaxation meditation tape

EXPERIMENTAL

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.

Behavioral: Relaxation meditation tape

Normal care

NO INTERVENTION

Participants in this arm will receive normal care from the Beijing Children Hospital

Interventions

Relaxation meditation tapeBEHAVIORAL

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.

relaxation meditation tape

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Children Hospital

Beijing, 100045, China

Location

Zhuang Wei

Beijing, 100192, China

Location

Related Publications (1)

  • 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.

    PMID: 31889973DERIVED

MeSH Terms

Conditions

Breast FeedingInfant BehaviorStress, PsychologicalBreast Milk Expression

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorChild BehaviorBehavioral Symptoms

Study Officials

  • Mary Fewtrell, PhD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in pediatric nutrition

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 17, 2018

Study Start

November 25, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

The IPD will only be used in a PhD thesis and further investigations

Locations

CN(2)