Mother and Late Preterm Lactation Study
- Conditions
- BreastfeedingPostnatal DepressionStress, PsychologicalPreterm Infant
- Interventions
- Other: Breastfeeding Support
- Registration Number
- NCT03791749
- Lead Sponsor
- University College, London
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
- 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
- Currently smoking or intending to smoke while breastfeeding
- Not based in London
- Prior breast surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Breastfeeding Support 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.
- Primary Outcome Measures
Name Time Method Maternal stress change at 6 weeks from 2 weeks post-delivery. 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. 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 Outcome Measures
Name Time Method Infant behaviour change at 6 weeks from 2 weeks post-delivery. Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally) Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary
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) Breast milk samples will be collected at 2 and 6 weeks post-delivery. Ghrelin, leptin, adiponectin and cortisol will be analysed (ng/ml) using the respective ELISA kits.
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) The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)
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 samples will be collected at 2 and 6 weeks post-delivery. Fat, protein and carbohydrate content of breast milk (g/100 ml) will be analysed using the Miris- Human Milk Analyser.
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) Breast milk volume (ml) will be assessed using 48-hour test weighing
Infant appetite change at 6 weeks from 2 weeks post-delivery. Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally) Infant appetite will be assessed using the Baby Eating Behaviour Questionnaire, with the following subscales (appetite traits): General Appetite (1 to 5 points), Enjoyment of Food (1 to 5 points), Satiety Responsiveness (1 to 5 points), Food Responsiveness (1 to 5 points), and Slowness in Eating (1 to 5 points). Higher scores on each subscale indicates a greater degree of the appetite trait.
Exclusive Breastfeeding Status 6 weeks, 3 months and 6 months postnatally Participants will be asked whether they are still exclusively breastfeeding their infants at 6 weeks, 3 months and 6 months postnatally to assess breastfeeding status.
Trial Locations
- Locations (1)
Royal Free Hospital
🇬🇧London, United Kingdom