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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2022-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Breastfeeding Intervention to Prevent Obesity Among Children

NCT06921382

Breastfeeding Self-Efficacy Breastfeeding Continuation Breastfeeding Duration +1 more

RECRUITING NA

Breastfeeding Preterm Infants - The Efficacy of Internet-based Peer Support

NCT02580786

Breast Feeding Infant, Premature

COMPLETED NA

The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants

NCT02120248

Breastfeeding

COMPLETED NA

Short-term Effects of Paced Bottle-Feeding on Feeding Interactions

NCT05780944

Mother-Infant Interaction Breastfeeding Bottle Feeding

COMPLETED NA

Mother and Late Preterm Lactation Study

NCT03791749

Breastfeeding Postnatal Depression Stress, Psychological +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Premature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

stepped wedge

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breastfeeding support program

Group Type EXPERIMENTAL

breastfeeding mother-to-mother support

Intervention Type 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.

Usual or routine care

Group Type OTHER

Control

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No