Breastfeed a Better Youngster: the BABY Study

NCT ID: NCT03674632

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-25
• Study Completion Date: 2020-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Relaxation meditation tape

Intervention Type: 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.

Normal care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Mary Fewtrell

Professor in pediatric nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Fewtrell, PhD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

Beijing Children Hospital

Beijing, , China

Zhuang Wei

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31889973 (View on PubMed)

Other Identifiers

18PE15

Identifier Type: -

Identifier Source: org_study_id