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

Not Applicable

Completed

• Conditions: Infant Premature
• Interventions: Behavioral: breastfeeding mother-to-mother support; Behavioral: Control

• Registration Number: NCT03156946
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2018-11-05
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1774

Inclusion Criteria

• any infant born <35 weeks' gestation,
• hospitalised in NICU before 24 hours old
• and younger than 168 hours (7 days) old.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Breastfeeding support program	breastfeeding mother-to-mother support	-
Usual or routine care	Control	-

Primary Outcome Measures

Name	Time	Method
Breastfeeding continuation rates	at corrected postnatal age of 2 months	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety by the Hospital Anxiety and Depression Scale (HADS)	at corrected postnatal age of 6 months
Neurodevelopment rate by Brunet Lézine scale	at corrected postnatal age of 24 months
Rate of breastfeeding initiated	at 2 months of corrected age
Posttraumatic stress by the Post-traumatic stress disorder Checklist version DSM-5 (PCL-5)	at corrected postnatal age of 6 months
Feasibility of the breastfeeding support program	24 months	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
Breastfeeding rate	at 6 months of corrected age
Breastfeeding duration	at 6 months of corrected age
Disability rate	at corrected postnatal age of 24 months	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.
Mother-Infant bonding	at corrected postnatal age of 6 months	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)
Infant behaviours	at corrected postnatal age of 6 months	Behavior will be assessed by the validated Infant Behavior questionnaire completed by mothers.
Depression by the Edinburgh Postnatal Depression Scale.	at corrected postnatal age of 6 months
Neonatal severe complications	at 36 weeks of corrected age	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.
Death rates	at 36 weeks of corrected age	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.
Costs effectiveness of breastfeeding	up to first two years of life	Costs will include initial hospitalization, hospital readmissions, outpatient visits and tests.
Parents stress by the Parenting Stress Index Fourth Edition Short Form (PSI-4 SF	at corrected postnatal age of 6 months
cost consequence of breastfeeding	up to first two years of life	Costs will include hospitalization rate and mortality between the two strategies.
Acceptability of the breastfeeding support program	24 months	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.

Trial Locations

Locations (8)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

CHU vaudois; 🇨🇭 Lausanne, Switzerland

CHU site Félix Guyon; 🇫🇷 Saint-Denis, Réunion, France

CH Lyon Sud; 🇫🇷 Pierre-Bénite, France

Hôpital Nord Ouest - Villefranche; 🇫🇷 Gleizé, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital des Enfants; 🇫🇷 Toulouse, France

CHC Clinique St-Vincent; 🇧🇪 Rocourt, Belgium