- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03791749
Mother and Late Preterm Lactation Study (MAPLeS)
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom
- Royal Free Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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12-minute simple technique
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No Intervention: Standard Care
Home visits will be conducted at 2-3 and 6-8 weeks post-delivery.
No intervention will be administered.
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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.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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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)
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Infant weight (kg) will be measured using an infant weighing scale.
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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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.
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Breast milk hormones change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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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.
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Breast milk volume change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Breast milk volume (ml) will be assessed using 48-hour test weighing
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Infant behaviour change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Infant appetite change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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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.
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.
Time Frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)
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Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
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Exclusive Breastfeeding Status
Time Frame: 6 weeks, 3 months and 6 months postnatally
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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.
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6 weeks, 3 months and 6 months postnatally
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS: 252031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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