Clinical Trials Logo

Clinical 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. 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03674632
Study type Interventional
Source University College, London
Contact
Status Completed
Phase N/A
Start date November 25, 2018
Completion date October 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT00579605 - Motivational Interviewing to Promote Sustained Breastfeeding N/A
Completed NCT05655364 - Development of a Breastfeeding Supportive Mobile Application N/A
Completed NCT03853850 - Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island N/A
Completed NCT03957941 - FamilyLink and Breastfeeding N/A
Withdrawn NCT03709004 - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression N/A
Completed NCT02958475 - Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers N/A
Active, not recruiting NCT05503069 - Community Interventions to Improve Breastfeeding N/A
Not yet recruiting NCT02233439 - Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues N/A
Completed NCT01893736 - Professional Breastfeeding Support Intervention N/A
Completed NCT02738957 - Effect of Prenatal Counseling on Breastfeeding Rates in Twins N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Completed NCT03655314 - Using the Electronic Health Record to Guide Management of Newborn Weight Loss N/A
Completed NCT05562245 - Motivational Interviewing-Based Breastfeeding Education N/A
Completed NCT05106634 - Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section
Completed NCT05992753 - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Recruiting NCT05213975 - Kinesio Taping Application After Cesarean Section N/A
Recruiting NCT05250219 - Microchimeric Cell Tranfer From Mother to Child - Pilo Study
Recruiting NCT05371106 - Mycotoxins in Mothers Milk in Israel
Completed NCT03332108 - Novel Approach To Improving Lactation Support With Mobile Health Technology N/A
Completed NCT02901665 - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes N/A