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Breastfeed a Better Youngster: the BABY Study

NCT03674632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-11-04

No results posted yet for this study

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).

Conditions

  • Breastfeeding
  • Breastfeeding, Exclusive
  • Infant Behavior
  • Psychological Stress
  • Breast Milk Expression
  • Infant Development

Interventions

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.

Sponsors & Collaborators

  • Beijing Children's Hospital

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Mary Fewtrell, PhD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-25
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674632 on ClinicalTrials.gov