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

Civil Hospices of Lyon

Status

Completed

Conditions

Infant Premature

Treatments

Behavioral: Control

Behavioral: breastfeeding mother-to-mother support

Study type

Interventional

Funder types

Other

Identifiers

NCT03156946

69HCL17_0033

Details and patient eligibility

About

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

Enrollment

1,774 patients

Sex

All

Ages

Under 35 weeks old

Volunteers

No Healthy Volunteers

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