MAPLeS: Mother and Late Preterm Lactation Study

Sponsor

University College, London (Other)

Overall Status

Completed

CT.gov ID

NCT03791749

Collaborator

(none)

Enrollment

Location

Arms

25.6

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding Postnatal Depression Stress, Psychological Preterm Infant	Other: Breastfeeding Support	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 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 :

Jan 25, 2019

Actual Primary Completion Date :

Jan 13, 2021

Actual Study Completion Date :

Mar 13, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

Maternal stress change at 6 weeks from 2 weeks post-delivery. [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.
Infant weight change at 6 weeks from 2 weeks post-delivery. [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

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 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. [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.
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)]
Breast milk volume (ml) will be assessed using 48-hour test weighing
Infant behaviour change at 6 weeks from 2 weeks post-delivery. [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
Infant appetite change at 6 weeks from 2 weeks post-delivery. [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.
Mother-infant attachment change at 6 weeks from 2 weeks post-delivery. [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)
Exclusive Breastfeeding Status [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

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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