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

Infant Premature Clinical Trial

— ALAIS  

Official title:

Breastfeeding Peer Counselling for Mothers of Preterm Neonates: a Stepped- Wedge Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156946
• Other study ID #: 69HCL17_0033
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: December 22, 2022

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1774
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 35 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant Premature

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	CHC Clinique St-Vincent	Rocourt
France	Hôpital Femme Mère Enfant	Bron
France	Hôpital Nord Ouest - Villefranche	Gleizé
France	CHU de Grenoble	Grenoble
France	CH Lyon Sud	Pierre-Bénite
France	CHU site Félix Guyon	Saint-Denis	Réunion
France	Hôpital des Enfants	Toulouse
Switzerland	CHU vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of breastfeeding initiated		at 2 months of corrected age
Secondary	Breastfeeding rate		at 2 months of corrected age
Secondary	Breastfeeding rate		at the end of NICU stay
Secondary	Breastfeeding rate		at 6 months of corrected age
Secondary	Breastfeeding duration		at 6 months of corrected age
Secondary	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.	at 36 weeks of corrected age
Secondary	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.	at 36 weeks of corrected age
Secondary	Infant behaviours	Behavior will be assessed by the validated Infant Behavior questionnaire completed by mothers.	at corrected postnatal age of 6 months
Secondary	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)	at corrected postnatal age of 6 months
Secondary	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.	at corrected postnatal age of 24 months
Secondary	Neurodevelopment rate by Brunet Lézine scale		at corrected postnatal age of 24 months
Secondary	Anxiety by the Hospital Anxiety and Depression Scale (HADS)		at corrected postnatal age of 6 months
Secondary	Depression by the Edinburgh Postnatal Depression Scale.		at corrected postnatal age of 6 months
Secondary	Posttraumatic stress by the Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)		at corrected postnatal age of 6 months
Secondary	Parents stress by the Parenting Stress Index Fourth Edition Short Form (PSI-4 SF		at corrected postnatal age of 6 months
Secondary	Costs effectiveness of breastfeeding	Costs will include initial hospitalization, hospital readmissions, outpatient visits and tests.	up to first two years of life
Secondary	cost consequence of breastfeeding	Costs will include hospitalization rate and mortality between the two strategies.	up to first two years of life
Secondary	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	24 months
Secondary	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.	24 months