NCT03156946

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,774 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 35 Weeks
• Healthy volunteers: Not accepted

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. 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

Conditions

• Infant Premature

Interventions

Type	Name	Description
BEHAVIORAL	breastfeeding mother-to-mother support	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.
BEHAVIORAL	Control	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.

Timeline

• Start date: 2018-11-05
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2017-05-17
• Last updated: 2025-11-21

Locations

8 sites across 3 countries: Belgium, France, Switzerland