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Completed

NCT Number: NCT03156946

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

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.

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

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Key information

Conditions

Infant Premature Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHC Clinique St-Vincent, Rocourt, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

breastfeeding mother-to-mother support

Behavioral

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.

Control

Behavioral

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.

Primary outcomes

  1. Breastfeeding continuation rates

    Time frame: at corrected postnatal age of 2 months

    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.

Secondary outcomes

  1. Rate of breastfeeding initiated

    Time frame: at 2 months of corrected age

  2. Breastfeeding rate

    Time frame: at 2 months of corrected age

  3. Breastfeeding rate

    Time frame: at the end of NICU stay

  4. Breastfeeding rate

    Time frame: at 6 months of corrected age

  5. Breastfeeding duration

    Time frame: at 6 months of corrected age

  6. Neonatal severe complications

    Time frame: at 36 weeks of corrected age

    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.

  7. Death rates

    Time frame: at 36 weeks of corrected age

    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.

  8. Infant behaviours

    Time frame: at corrected postnatal age of 6 months

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

  9. Mother-Infant bonding

    Time frame: at corrected postnatal age of 6 months

    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)

  10. Disability rate

    Time frame: at corrected postnatal age of 24 months

    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.

  11. Neurodevelopment rate by Brunet Lézine scale

    Time frame: at corrected postnatal age of 24 months

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

    Time frame: at corrected postnatal age of 6 months

  13. Depression by the Edinburgh Postnatal Depression Scale.

    Time frame: at corrected postnatal age of 6 months

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

    Time frame: at corrected postnatal age of 6 months

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

    Time frame: at corrected postnatal age of 6 months

  16. Costs effectiveness of breastfeeding

    Time frame: up to first two years of life

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

  17. cost consequence of breastfeeding

    Time frame: up to first two years of life

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

  18. Feasibility of the breastfeeding support program

    Time frame: 24 months

    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

  19. Acceptability of the breastfeeding support program

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ALAIS

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 17, 2017
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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