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Completed

NCT Number: NCT03791749

Mother and Late Preterm Lactation Study

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).

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Key information

Conditions

Breastfeeding Behavior Behavioral Symptoms Breast Feeding Depression, Postpartum Depressive Disorder Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Obstetric Labor Complications Obstetric Labor, Premature Postnatal Depression Pregnancy Complications Premature Birth Preterm Infant Puerperal Disorders Stress, Psychological Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Free Hospital

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding Support

Other

12-minute simple technique

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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.

Acronym: MAPLeS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2019
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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