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Mother and Late Preterm Lactation Study

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03791749
Acronym
MAPLeS
Enrollment
72
Registered
2019-01-03
Start date
2019-01-25
Completion date
2021-03-13
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Postnatal Depression, Preterm Infant, Stress, Psychological

Keywords

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

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).

Interventions

OTHERBreastfeeding Support

12-minute simple technique

Sponsors

University College, London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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
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.
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 Status6 weeks, 3 months and 6 months postnatallyParticipants will be asked whether they are still exclusively breastfeeding their infants at 6 weeks, 3 months and 6 months postnatally to assess breastfeeding status.
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.
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 16, 2026