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Infant PrematureALAISNCT03156946

Evaluation of a Peer Counseling Breastfeeding Support Program for Mother-preterm Infant Dyads

A study testing breastfeeding mother-to-mother support in people with Infant Premature, run by Hospices Civils de Lyon at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women's health. Breastfeeding protects against gastrointestinal and respiratory illnesses and is associated with better cognitive development in childhood, particularly in preterm infants. Read more about this study

Who is it for?
Ages Up to 35 weeks
Conditions the study is for
Infant Premature
What is being tested?
breastfeeding mother-to-mother support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,774 participants
Where
8 sitesin 3 countries
Study dates
5 Nov 2018to 22 Dec 2022
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 Up to 35 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • any infant born <35 weeks' gestation,
  • hospitalised in NICU before 24 hours old
  • and younger than 168 hours (7 days) old.

Who cannot join

  • infant with foetal malformation that is life-threatening
  • infant with medical contraindication for breastfeeding
  • parent(s)' non-consent to be involved in the study
  • mother with prolonged medical contraindication for breastfeeding
  • mother with psychiatric disorders making breastfeeding support impossible
  • if no communication is possible with the mother
  • if the level of communication with the mother does not allow breastfeeding support, with or without a third party

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

France6 sites

  • Hôpital Femme Mère Enfant

    Bron

  • Hôpital Nord Ouest - Villefranche

    Gleizé

  • CHU de Grenoble

    Grenoble

  • CH Lyon Sud

    Pierre-Bénite

  • CHU site Félix Guyon

    Saint-Denis, Réunion, 97400

  • Hôpital des Enfants

    Toulouse

Other trials in France

Belgium1 site

  • CHC Clinique St-Vincent

    Rocourt

Other trials in Belgium

Switzerland1 site

  • CHU vaudois

    Lausanne

Other trials in Switzerland

About this study

Official title: Breastfeeding Peer Counselling for Mothers of Preterm Neonates: a Stepped- Wedge Cluster Randomized Controlled Trial

Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women's health. Breastfeeding protects against gastrointestinal and respiratory illnesses and is associated with better cognitive development in childhood, particularly in preterm infants. Despite these potential benefits, preterm infants experience lower rates of breastfeeding initiation and continuation compared to term infants.

The use of breastfeeding peer support initiatives, in which advice is given by experienced and trained peer counselors, is an effective way to promote and support breastfeeding, regardless of a woman's socioeconomic status. Several small studies have shown that breastfeeding peer support initiatives were effective for preterm infants and that this efficacy was increased by the co-intervention of lactation consultants.

Read more

The purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding support program among mother-preterm infant dyads in Europe, by evaluating the impact of the intervention on 1) breastfeeding rates, 2) morbidity and mortality during the hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health, 4) costs benefits.

The breastfeeding support program will include peer counselors under the supervision of lactation consultants. Breastfeeding counselors will be voluntary mothers who have had a positive breastfeeding experience with at least one preterm infant. After a training course, they will meet the future or new mothers by face-to-face and share their experiences at least once a week during hospitalization and provide phone support up to 1 month after discharge from hospital.

The study design will be a stepped wedge cluster trial conducted in 8 NICU in Europe (France, Switzerland and Belgium). Infants and mothers will be followed up from the time of hospitalization in the maternity and NICU up to 6 months after the discharge. The cost analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed up at 24-months after their discharge

Being tested
breastfeeding mother-to-mother support, Control
Keywords
breastfeeding, mother-to-mother support, lactation consultant, stepped wedge cluster randomized trial, peer counseling
Medical subject headings
Premature Birth, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • breastfeeding mother-to-mother supportBehavioural

    The mother-infant dyads in the intervention arm will receive breastfeeding mother-to-mother support from the hospitalization in the maternity and NICU up to 1 month after discharge. The intervention will be in addition to the usual or routine care. Breastfeeding counselors will be voluntary mothers who breastfed their own preterm infant (aged between 6 months and 5 years at the time of the study) for a minimum of 2 months, and who have had a positive personal breastfeeding experience, and who have undertaken a training course.

  • ControlBehavioural

    The mother-infant dyads in the control arm will continue to receive the usual/routine care provided by participating centers during the hospitalization and Mother and Infant Protection service after discharge.

Study groups in NCT03156946
Study groupRoleWhat they receive
Breastfeeding support programExperimentalNot described
Receives: Behavioral: breastfeeding mother-to-mother support
Usual or routine careOtherNot described
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breastfeeding continuation rates

    Breastfeeding will be defined as the consumption of any mother's own milk. It will be classed as exclusive when all of the fed milk is the mother's own milk, or mixed when it will be completed by other milk and/or food.

    Measured: at corrected postnatal age of 2 months

Secondary outcomes (19)

  1. Rate of breastfeeding initiated

    Measured: at 2 months of corrected age

  2. Breastfeeding rate

    Measured: at 2 months of corrected age

  3. Breastfeeding rate

    Measured: at the end of NICU stay

  4. Breastfeeding rate

    Measured: at 6 months of corrected age

  5. Breastfeeding duration

    Measured: at 6 months of corrected age

  6. Neonatal severe complications

    Morbidity outcomes will include intraventricular haemorrhage grade≥3, periventricular leucomalacia, sepsis (proven or clinical), persistent ductus arteriosus requiring treatment, necrotising enterocolitis grade≥2, and bronchopulmonary dysplasia (need of oxygen and/or ventilation support at 36 weeks of corrected age), retinopathy of prematurity grade>2.

    Measured: at 36 weeks of corrected age

  7. Death rates

    Morbidity outcomes will include intraventricular haemorrhage grade≥3, periventricular leucomalacia, sepsis (proven or clinical), persistent ductus arteriosus requiring treatment, necrotising enterocolitis grade≥2, and bronchopulmonary dysplasia (need of oxygen and/or ventilation support at 36 weeks of corrected age), retinopathy of prematurity grade>2.

    Measured: at 36 weeks of corrected age

  8. Infant behaviours

    Behavior will be assessed by the validated Infant Behavior questionnaire completed by mothers.

    Measured: at corrected postnatal age of 6 months

  9. Mother-Infant bonding

    Disabilities will include cerebral palsy, mental retardation assessed by the developmental quotient less than 85 on the Brunet- Lézine scale, and visual and hearing deficits. -Infant bonding assessed by the Mother-Infant Bonding Scale (MIBS)

    Measured: at corrected postnatal age of 6 months

  10. Disability rate

    Disabilities will include cerebral palsy, mental retardation assessed by the developmental quotient less than 85 on the Brunet- Lézine scale, and visual and hearing deficits.

    Measured: at corrected postnatal age of 24 months

  11. Neurodevelopment rate by Brunet Lézine scale

    Measured: at corrected postnatal age of 24 months

  12. Anxiety by the Hospital Anxiety and Depression Scale (HADS)

    Measured: at corrected postnatal age of 6 months

  13. Depression by the Edinburgh Postnatal Depression Scale.

    Measured: at corrected postnatal age of 6 months

  14. Posttraumatic stress by the Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)

    Measured: at corrected postnatal age of 6 months

  15. Parents stress by the Parenting Stress Index Fourth Edition Short Form (PSI-4 SF

    Measured: at corrected postnatal age of 6 months

  16. Costs effectiveness of breastfeeding

    Costs will include initial hospitalization, hospital readmissions, outpatient visits and tests.

    Measured: up to first two years of life

  17. cost consequence of breastfeeding

    Costs will include hospitalization rate and mortality between the two strategies.

    Measured: up to first two years of life

  18. Feasibility of the breastfeeding support program

    To assess the feasibility of the intervention, we will depict : - the socio-demographic characteristics of breastfeeding counselors - and the number of contacts between mothers and breastfeeding counselors (frequency and duration) and the information

    Measured: 24 months

  19. Acceptability of the breastfeeding support program

    To assess the acceptability of the breastfeeding support program, we will collect :

    • the perception of breastfeeding support by mothers and their spouses, by staff members (lactation consultant, nurses) in each participating centers and by breastfeeding counselors.
    • the number of mothers who refuse to be managed by a breastfeeding counselors and their reasons,
    • the duration of each breastfeeding counselor intervention and the number of mothers who will stop the intervention before 1 month after the hospital discharge.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start5 Nov 2018
  3. Primary completion22 Dec 2022
  4. Study completion22 Dec 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
stepped wedge
Masking
None (open label)
Enrolment
1,774 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03156946
Sponsor's protocol ID
69HCL17_0033
Acronym
ALAIS
Status last verified
Nov 2025
First submitted
2 May 2017
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laborie S, Denis A, Horsch A, Occelli P, Margier J, Morisod Harari M, Claris O, Touzet S, Fischer Fumeaux CJ. Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial. BMJ Open. 2020 Jan 30;10(1):e032910. doi: 10.1136/bmjopen-2019-032910.

    PubMed 32005780

Questions about this trial

What is this clinical trial studying?

A study testing breastfeeding mother-to-mother support in people with Infant Premature, run by Hospices Civils de Lyon at 8 sites in 3 countries.

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 3 inclusion and 7 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Belgium, Switzerland. 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?

Breastfeeding continuation rates (time frame: at corrected postnatal age of 2 months). 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 NCT03156946, which also lists 1 linked publication.

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 21 Nov 2025.

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