Clinical trial NCT03791749: Mother and Late Preterm Lactation Study
Official title: A Randomised Controlled Trial Testing the Use of a Simple Intervention on Maternal Psychological State, Breast Milk Composition and Volume, and Infant Behaviour and Growth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Postnatal Depression
Stress, Psychological
Preterm Infant
Keywords: breastfeeding
postnatal mental health
breastfeeding support
stress
late preterm infant
breast milk
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breastfeeding has various benefits for the mother and infant. It has the capability of reducing the risk of short term and long term problems for the infant, such as gastroenteritis, respiratory infections, type II diabetes and obesity, and of providing benefits for neurodevelopment. Breast milk offers even greater benefits for preterm infants. Some of the advantages of breastfeeding are related to the constituents of breast milk such as the macronutrients and bioactive factors, the hormones associated with breastfeeding such as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant cues). Despite these advantages, breastfeeding rates are below target levels mainly due to the challenges that women face that hinder breastfeeding success. Interventions aimed at improving policies, practices, and maternal support have been developed. However, other interventions that target specific modifiable barriers to breastfeeding can be useful.

The aim of this study is to investigate a simple support intervention for breastfeeding mothers of late preterm and early term infants on maternal stress reduction and infant weight gain. The investigators also aim to study the potential mechanisms by which this effect could be achieved (breast milk composition and volume, mother and infant behaviour).


Eligibility criteria: Inclusion Criteria:

* Mothers of late preterm infants (34 to \<37 weeks) or early term infants (37 to 38 weeks)
* Intending to breastfeed for at least 6 weeks
* Free from serious illness
* Fluent in English

Exclusion Criteria:

* Currently smoking or intending to smoke while breastfeeding
* Not based in London
* Prior breast surgery

Primary outcomes:
measure: Maternal stress change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
measure: Infant weight change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary outcomes:
measure: Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
measure: Breast milk hormones change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
measure: Breast milk volume change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
measure: Infant behaviour change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
measure: Infant appetite change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
measure: Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.
timeFrame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
measure: Exclusive Breastfeeding Status
timeFrame: 6 weeks, 3 months and 6 months postnatally
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
References:
citation: Dib S, Wells JCK, Fewtrell M. Mother And late Preterm Lactation Study (MAPLeS): a randomised controlled trial testing the use of a breastfeeding meditation by mothers of late preterm infants on maternal psychological state, breast milk composition and volume, and infant behaviour and growth. Trials. 2020 Apr 7;21(1):318. doi: 10.1186/s13063-020-4225-3.