Mother and Late Preterm Lactation Study

NCT03791749 | Completed

• 1 other identifier: IRAS: 252031
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Breastfeeding; Postnatal Depression; Stress, Psychological; Preterm Infant

Keywords

breastfeeding; postnatal mental health; breastfeeding support; stress; late preterm infant; breast milk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.

  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.

  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.

  Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)

• Infant behaviour change at 6 weeks from 2 weeks post-delivery.

  Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)

• Infant appetite change at 6 weeks from 2 weeks post-delivery.

  Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)

Study Arms (2)

Breastfeeding Support

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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

Interventions

Breastfeeding Support OTHER

12-minute simple technique

Breastfeeding Support

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Currently smoking or intending to smoke while breastfeeding
• Not based in London
• Prior breast surgery

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Royal Free Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32264947 DERIVED

MeSH Terms

Conditions

Breast Feeding; Depression, Postpartum; Stress, Psychological; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 3, 2019
• Study Start: January 25, 2019
• Primary Completion: January 13, 2021
• Study Completion: March 13, 2021
• Last Updated: July 19, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)