Mother and Late Preterm Lactation Study

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).

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.

Conditions
-----------------
Breastfeeding, Postnatal Depression, Stress, Psychological, Preterm Infant

Intervention / Treatment
-----------------
* Other: Breastfeeding Support


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding Support<br>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. | Other: Breastfeeding Support<br>* 12-minute simple technique<br>|
| No Intervention: Standard Care<br>Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breastfeeding, postnatal mental health, breastfeeding support, stress, late preterm infant, breast milk