Clinical Trials Directory

Trials / Completed

CompletedNCT01971216

Mother-infant Signalling During Breastfeeding

Mother-infant Signalling During Breastfeeding: A Randomised Trial Investigating the Effects of a Relaxation Intervention in Breastfeeding Mothers on Breast Milk Production, Breast Milk Cortisol and Infant Behaviour and Growth.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
University College, London · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

Primary hypotheses 1\. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition) Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRelaxation

Timeline

Start date
2013-12-01
Primary completion
2015-03-01
Completion
2017-01-01
First posted
2013-10-29
Last updated
2018-07-12

Locations

1 site across 1 country: Malaysia

Source: ClinicalTrials.gov record NCT01971216. Inclusion in this directory is not an endorsement.