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

NCT03156946 | Completed

• 1 other identifier: 69HCL17_0033
• Study Type: interventional
• Target: 1,774
• Locations: 3 countries
• Sites: 8

Brief 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

Keywords

breastfeeding; mother-to-mother support; lactation consultant; stepped wedge cluster randomized trial; peer counseling

Outcome Measures

Primary Outcomes (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.

  at corrected postnatal age of 2 months

Secondary Outcomes (19)

• Rate of breastfeeding initiated

  at 2 months of corrected age

• Breastfeeding rate

  at 2 months of corrected age

• Breastfeeding rate

  at the end of NICU stay

• Breastfeeding rate

  at 6 months of corrected age

• Breastfeeding duration

  at 6 months of corrected age

Study Arms (2)

Breastfeeding support program

EXPERIMENTAL

Behavioral: breastfeeding mother-to-mother support

Usual or routine care

OTHER

Behavioral: Control

Interventions

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.

Breastfeeding support program

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.

Usual or routine care

Eligibility Criteria

• Age: Up to 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (8)

CHC Clinique St-Vincent

Rocourt, Belgium

Location

CHU site Félix Guyon

Saint-Denis, Réunion, 97400, France

Location

Hôpital Femme Mère Enfant

Bron, France

Location

Hôpital Nord Ouest - Villefranche

Gleizé, France

Location

CHU de Grenoble

Grenoble, France

Location

CH Lyon Sud

Pierre-Bénite, France

Location

Hôpital des Enfants

Toulouse, France

Location

CHU vaudois

Lausanne, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32005780 RESULT

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Sophie Laborie, MD

  Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Bron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: stepped wedge

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 17, 2017
• Study Start: November 5, 2018
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); CH (1); BE (1)