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Mother and Late Preterm Lactation Study (MAPLeS)

Primary Purpose

Breastfeeding, Postnatal Depression, Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Breastfeeding Support
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breastfeeding focused on measuring breastfeeding, postnatal mental health, breastfeeding support, stress, late preterm infant, breast milk

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breastfeeding Support

Standard Care

Arm Description

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.

Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered.

Outcomes

Primary Outcome Measures

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.
Infant weight change at 6 weeks from 2 weeks post-delivery.
Infant weight (kg) will be measured using an infant weighing scale.

Secondary Outcome Measures

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.
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.
Breast milk volume change at 6 weeks from 2 weeks post-delivery.
Breast milk volume (ml) will be assessed using 48-hour test weighing
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
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.
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)
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.

Full Information

First Posted
December 27, 2018
Last Updated
July 18, 2022
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03791749
Brief Title
Mother and Late Preterm Lactation Study
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
March 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Postnatal Depression, Stress, Psychological, Preterm Infant
Keywords
breastfeeding, postnatal mental health, breastfeeding support, stress, late preterm infant, breast milk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breastfeeding Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered.
Intervention Type
Other
Intervention Name(s)
Breastfeeding Support
Intervention Description
12-minute simple technique
Primary Outcome Measure Information:
Title
Maternal stress change at 6 weeks from 2 weeks post-delivery.
Description
Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Title
Infant weight change at 6 weeks from 2 weeks post-delivery.
Description
Infant weight (kg) will be measured using an infant weighing scale.
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Secondary Outcome Measure Information:
Title
Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.
Description
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.
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Title
Breast milk hormones change at 6 weeks from 2 weeks post-delivery.
Description
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.
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Title
Breast milk volume change at 6 weeks from 2 weeks post-delivery.
Description
Breast milk volume (ml) will be assessed using 48-hour test weighing
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Title
Infant behaviour change at 6 weeks from 2 weeks post-delivery.
Description
Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Title
Infant appetite change at 6 weeks from 2 weeks post-delivery.
Description
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.
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Title
Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.
Description
The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)
Time Frame
Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Title
Exclusive Breastfeeding Status
Description
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.
Time Frame
6 weeks, 3 months and 6 months postnatally

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32264947
Citation
Dib S, Wells JCK, Fewtrell M. Mother And late Preterm Lactation Study (MAPLeS): a randomised controlled trial testing the use of a breastfeeding meditation by mothers of late preterm infants on maternal psychological state, breast milk composition and volume, and infant behaviour and growth. Trials. 2020 Apr 7;21(1):318. doi: 10.1186/s13063-020-4225-3.
Results Reference
derived

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Mother and Late Preterm Lactation Study

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