Clinical trial NCT03156946: Evaluation of a Peer Counseling Breastfeeding Support Program for Mother-preterm Infant Dyads
Official title: Breastfeeding Peer Counselling for Mothers of Preterm Neonates: a Stepped- Wedge Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Premature
Keywords: breastfeeding
mother-to-mother support
lactation consultant
stepped wedge cluster randomized trial
peer counseling
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 1774
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: stepped wedge
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Breastfeeding continuation rates
timeFrame: at corrected postnatal age of 2 months
Secondary outcomes:
measure: Rate of breastfeeding initiated
timeFrame: at 2 months of corrected age
measure: Breastfeeding rate
timeFrame: at 2 months of corrected age
measure: Breastfeeding rate
timeFrame: at the end of NICU stay
measure: Breastfeeding rate
timeFrame: at 6 months of corrected age
measure: Breastfeeding duration
timeFrame: at 6 months of corrected age
measure: Neonatal severe complications
timeFrame: at 36 weeks of corrected age
measure: Death rates
timeFrame: at 36 weeks of corrected age
measure: Infant behaviours
timeFrame: at corrected postnatal age of 6 months
measure: Mother-Infant bonding
timeFrame: at corrected postnatal age of 6 months
measure: Disability rate
timeFrame: at corrected postnatal age of 24 months
measure: Neurodevelopment rate by Brunet Lézine scale
timeFrame: at corrected postnatal age of 24 months
measure: Anxiety by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: at corrected postnatal age of 6 months
measure: Depression by the Edinburgh Postnatal Depression Scale.
timeFrame: at corrected postnatal age of 6 months
measure: Posttraumatic stress by the Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
timeFrame: at corrected postnatal age of 6 months
measure: Parents stress by the Parenting Stress Index Fourth Edition Short Form (PSI-4 SF
timeFrame: at corrected postnatal age of 6 months
measure: Costs effectiveness of breastfeeding
timeFrame: up to first two years of life
measure: cost consequence of breastfeeding
timeFrame: up to first two years of life
measure: Feasibility of the breastfeeding support program
timeFrame: 24 months
measure: Acceptability of the breastfeeding support program
timeFrame: 24 months
Other outcomes:
Locations:
city: Rocourt
country: Belgium
facility: CHC Clinique St-Vincent
city: Saint-Denis
country: France
facility: CHU site Félix Guyon
state: Réunion
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Gleizé
country: France
facility: Hôpital Nord Ouest - Villefranche
city: Grenoble
country: France
facility: CHU de Grenoble
city: Pierre-Bénite
country: France
facility: CH Lyon Sud
city: Toulouse
country: France
facility: Hôpital des Enfants
city: Lausanne
country: Switzerland
facility: CHU vaudois
Study officials:
affiliation: Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Bron
name: Sophie Laborie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.