Clinical trial NCT01971216: Mother-infant Signalling During Breastfeeding
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding Women
Keywords: Breastfeeding, relaxation, anxiety, infant growth
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

Primiparous mother with singleton pregnancy Infant is singleton and born at term (37-42 week of gestation) Infant birth weight of \>2500 g (5,5 pounds or 5 pounds and 8,2 ounces) Mother and infant are generally healthy (free of serious illness that can affect breastfeeding or nursing infant, or energy balance of the infant).

No current or recent involvement in other research studies that could potentially affect any of outcome measures.

Mother speaks and understands either English only or English and Malay (some questionnaires are in English)

Exclusion Criteria:

Mother or baby has a major illness that affects nursing or breastfeeding, or affects energy balance of the infant.

Mother smokes Mothers who do not exclusively breastfeed their infant

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Primary outcomes:
measure: Maternal stress and anxiety
timeFrame: Baselibne to 12 weeks
measure: Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
timeFrame: 12 weeks
measure: Breast milk cortisol concentrations at 12 weeks
timeFrame: 12 weeks
measure: Infant behaviour measured using a 3-day diary at 12 weeks
timeFrame: 12 weeks
measure: Infant weight and body composition measured using stable isotopes at 12 weeks
timeFrame: 12 weeks
measure: Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks.
timeFrame: 2,6,12 weeks
Secondary outcomes:
measure: Non-nutrient factors in breast milk - leptin and ghrelin
timeFrame: 2,6,12 weeks
measure: Macronutrient composition of breast milk (fat and protein)
timeFrame: 2,6,12 weeks
Other outcomes:
measure: Infant temperament measured using the Rothbart questionnaire
timeFrame: 12 weeks
measure: Infant appetite assessed using the BEBQ
timeFrame: 2,6,12 weeks
measure: Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 2 weeks
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).
Study officials:
affiliation: UCL Institute of Child Health, London
name: Mary Fewtrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
citation: Shukri NHM, Wells J, Mukhtar F, Lee MHS, Fewtrell M. Study protocol: An investigation of mother-infant signalling during breastfeeding using a randomised trial to test the effectiveness of breastfeeding relaxation therapy on maternal psychological state, breast milk production and infant behaviour and growth. Int Breastfeed J. 2017 Jul 14;12:33. doi: 10.1186/s13006-017-0124-y. eCollection 2017.