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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,774
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.
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.
CHC Clinique St-Vincent
Rocourt, Belgium
CHU site Félix Guyon
Saint-Denis, Réunion, France
Hôpital Femme Mère Enfant
Bron, France
Hôpital Nord Ouest - Villefranche
Gleizé, France
CHU de Grenoble
Grenoble, France
CH Lyon Sud
Pierre-Bénite, France
Hôpital des Enfants
Toulouse, France
CHU vaudois
Lausanne, Switzerland
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.
Time frame: at corrected postnatal age of 2 months
Rate of breastfeeding initiated
Time frame: at 2 months of corrected age
Breastfeeding rate
Time frame: at 2 months of corrected age
Breastfeeding rate
Time frame: at the end of NICU stay
Breastfeeding rate
Time frame: at 6 months of corrected age
Breastfeeding duration
Time frame: at 6 months of corrected age
Neonatal severe complications
Morbidity outcomes will include intraventricular haemorrhage grade≥3, periventricular leucomalacia, sepsis (proven or clinical), persistent ductus arteriosus requiring treatment, necrotising enterocolitis grade≥2, and bronchopulmonary dysplasia (need of oxygen and/or ventilation support at 36 weeks of corrected age), retinopathy of prematurity grade\>2.
Time frame: at 36 weeks of corrected age
Death rates
Morbidity outcomes will include intraventricular haemorrhage grade≥3, periventricular leucomalacia, sepsis (proven or clinical), persistent ductus arteriosus requiring treatment, necrotising enterocolitis grade≥2, and bronchopulmonary dysplasia (need of oxygen and/or ventilation support at 36 weeks of corrected age), retinopathy of prematurity grade\>2.
Time frame: at 36 weeks of corrected age
Infant behaviours
Behavior will be assessed by the validated Infant Behavior questionnaire completed by mothers.
Time frame: at corrected postnatal age of 6 months
Mother-Infant bonding
Disabilities will include cerebral palsy, mental retardation assessed by the developmental quotient less than 85 on the Brunet- Lézine scale, and visual and hearing deficits. -Infant bonding assessed by the Mother-Infant Bonding Scale (MIBS)
Time frame: at corrected postnatal age of 6 months
Disability rate
Disabilities will include cerebral palsy, mental retardation assessed by the developmental quotient less than 85 on the Brunet- Lézine scale, and visual and hearing deficits.
Time frame: at corrected postnatal age of 24 months
Neurodevelopment rate by Brunet Lézine scale
Time frame: at corrected postnatal age of 24 months
Anxiety by the Hospital Anxiety and Depression Scale (HADS)
Time frame: at corrected postnatal age of 6 months
Depression by the Edinburgh Postnatal Depression Scale.
Time frame: at corrected postnatal age of 6 months
Posttraumatic stress by the Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)
Time frame: at corrected postnatal age of 6 months
Parents stress by the Parenting Stress Index Fourth Edition Short Form (PSI-4 SF
Time frame: at corrected postnatal age of 6 months
Costs effectiveness of breastfeeding
Costs will include initial hospitalization, hospital readmissions, outpatient visits and tests.
Time frame: up to first two years of life
cost consequence of breastfeeding
Costs will include hospitalization rate and mortality between the two strategies.
Time frame: up to first two years of life
Feasibility of the breastfeeding support program
To assess the feasibility of the intervention, we will depict : - the socio-demographic characteristics of breastfeeding counselors - and the number of contacts between mothers and breastfeeding counselors (frequency and duration) and the information
Time frame: 24 months
Acceptability of the breastfeeding support program
To assess the acceptability of the breastfeeding support program, we will collect : * the perception of breastfeeding support by mothers and their spouses, by staff members (lactation consultant, nurses) in each participating centers and by breastfeeding counselors. * the number of mothers who refuse to be managed by a breastfeeding counselors and their reasons, * the duration of each breastfeeding counselor intervention and the number of mothers who will stop the intervention before 1 month after the hospital discharge.
Time frame: 24 months
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