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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Maternal stress change at 6 weeks from 2 weeks post-delivery.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Breastfeeding Support
Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. Mothers will be asked to perform a simple technique while breastfeeding at least once a day.
Intervention: Breastfeeding Support (Other)
Standard Care
Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered.
Outcomes
Primary Outcomes
Maternal stress change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.
Infant weight change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Infant weight (kg) will be measured using an infant weighing scale.
Secondary Outcomes
- Infant behaviour change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
- Breast milk hormones change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
- Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
- Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
- Breast milk volume change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
- Infant appetite change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
- Exclusive Breastfeeding Status(6 weeks, 3 months and 6 months postnatally)