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Mother and Late Preterm Lactation Study (MAPLeS)

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ClinicalTrials.gov Identifier: NCT03791749
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Description
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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).


Condition or disease Intervention/treatment Phase
Breastfeeding Postnatal Depression Stress, Psychological Preterm Infant Other: Breastfeeding Support Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 25, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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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.
 Other: Breastfeeding Support
12-minute simple technique
No Intervention: Standard Care
Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.

  2. 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) ]
    Infant weight (kg) will be measured using an infant weighing scale.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    Breast milk volume (ml) will be assessed using 48-hour test weighing

  4. 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) ]
    Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary

  5. 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) ]
    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.

  6. 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) ]
    The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)

  7. Exclusive Breastfeeding Status [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791749


Contacts
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Contact: Sarah Dib, MSc +447746771009 sarah.dib.15@ucl.ac.uk

Locations
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United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom
Contact: Sarah Dib         
Sponsors and Collaborators
University College, London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03791749    
Other Study ID Numbers: IRAS: 252031
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
breastfeeding
postnatal mental health
breastfeeding support
 stress
late preterm infant
breast milk
Additional relevant MeSH terms:
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Premature Birth
Depression, Postpartum
Stress, Psychological
Behavioral Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Puerperal Disorders
Depressive Disorder
Mood Disorders
Mental Disorders