Mother and Late Preterm Lactation Study

Stress, Psychological Clinical Trial

— MAPLeS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791749
• Other study ID #: IRAS: 252031
• Status: Completed
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: March 13, 2021

Study information

• Verified date: December 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Depression, Postpartum
• Postnatal Depression
• Premature Birth
• Preterm Infant
• Stress, Psychological

Intervention

Other:
• Breastfeeding Support
12-minute simple technique

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal stress change at 6 weeks from 2 weeks post-delivery.	Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Primary	Infant weight change at 6 weeks from 2 weeks post-delivery.	Infant weight (kg) will be measured using an infant weighing scale.	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary	Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.	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.	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary	Breast milk hormones change at 6 weeks from 2 weeks post-delivery.	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.	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary	Breast milk volume change at 6 weeks from 2 weeks post-delivery.	Breast milk volume (ml) will be assessed using 48-hour test weighing	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary	Infant behaviour change at 6 weeks from 2 weeks post-delivery.	Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary	Infant appetite change at 6 weeks from 2 weeks post-delivery.	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.	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary	Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.	The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)	Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary	Exclusive Breastfeeding Status	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.	6 weeks, 3 months and 6 months postnatally