BreastfeedingMAPLeSNCT03791749
Mother and Late Preterm Lactation Study
A study testing Breastfeeding Support in people with Breastfeeding and Postnatal Depression, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Postnatal Depression, Stress, Psychological
- What is being tested?
- Breastfeeding Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2019to 13 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Currently smoking or intending to smoke while breastfeeding
- Not based in London
- Prior breast surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Being tested
- Breastfeeding Support
- Keywords
- breastfeeding, postnatal mental health, breastfeeding support, stress, late preterm infant, breast milk
- Medical subject headings
- Breast Feeding, Depression, Postpartum, Stress, Psychological, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding SupportOther
12-minute simple technique
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Breast milk volume (ml) will be assessed using 48-hour test weighing
Measured: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Infant behaviour change at 6 weeks from 2 weeks post-delivery.
Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary
Measured: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Infant appetite change at 6 weeks from 2 weeks post-delivery.
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.
Measured: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.
The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)
Measured: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
Exclusive Breastfeeding Status
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.
Measured: 6 weeks, 3 months and 6 months postnatally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start25 Jan 2019
- Primary completion13 Jan 2021
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791749
- Sponsor's protocol ID
- IRAS: 252031
- Acronym
- MAPLeS
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dib S, Wells JCK, Fewtrell MS. Early Hospital Practices Were Associated With Exclusive Breastfeeding Among Late Preterm and Early Term Infants. Acta Paediatr. 2026 Aug 14. doi: 10.1111/apa.70723. Online ahead of print.
PubMed 42598933Dib 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.
PubMed 32264947
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03791749
- Acronym / sponsor ID
- MAPLeS / IRAS: 252031
- Keywords
- breastfeeding, postnatal mental health, breastfeeding support, stress, late preterm infant, breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Support | Experimental | Other: Breastfeeding SupportHome 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. |
| Standard Care | No intervention | –Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Currently smoking or intending to smoke while breastfeeding
- Not based in London
- Prior breast surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding Support12-minute simple technique | Other | Breastfeeding Support |
Primary outcome
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.
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.
7 secondary outcomes
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 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 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)
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)
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)
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)
Exclusive Breastfeeding Status
Time frame: 6 weeks, 3 months and 6 months postnatally
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 42598933Dib S, Wells JCK, Fewtrell MS. Early Hospital Practices Were Associated With Exclusive Breastfeeding Among Late Preterm and Early Term Infants. Acta Paediatr. 2026 Aug 14. doi: 10.1111/apa.70723. Online ahead of print.
- Derived from this study: PubMed 32264947Dib 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Support in people with Breastfeeding and Postnatal Depression, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791749, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022; AzTrials last refreshed its copy on 28 Oct 2026.