Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871853
Status:
RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-15
Brief Title:
Get the Benefits From the Start Improving Breastfeeding
Sponsor:
Slagelse Hospital
Organization:
Slagelse Hospital
Study Overview
Official Title:
Getting the Benefits From the Beginning Improving Breastfeeding Support for Families at Risk of Breastfeeding Difficulties
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breastfeeding is beneficial for the physical and mental health of mothers and infants alike
Most new mothers in Denmark intend to breastfeed however a substantial proportion do not succeed to breastfeed as intended
In Region Zealand few women breastfeed than in the rest of Denmark in which may be related to a higher proportion of women being overweight having socio-economic constraints and a low educational level all associated with breastfeeding difficulties There is limited knowledge on how to deliver a tailored support aimed at families at high risk of breastfeeding difficulties in a high-income country
We plan to conduct a study aiming to strengthen breastfeeding support to families at risk of breastfeeding difficulties delivering at Slagelse Hospital across healthcare sectors including obstetric and neonatal departments primary care and civil society
The study aims to develop implement and evaluate a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand Denmark
Potentially results can help reducing inequality in health thus more families achieve exclusive breastfeeding and gain health benefits from breastfeeding
Most new mothers in Denmark intend to breastfeed however a substantial proportion do not succeed to breastfeed as intended
In Region Zealand few women breastfeed than in the rest of Denmark in which may be related to a higher proportion of women being overweight having socio-economic constraints and a low educational level all associated with breastfeeding difficulties There is limited knowledge on how to deliver a tailored support aimed at families at high risk of breastfeeding difficulties in a high-income country
We plan to conduct a study aiming to strengthen breastfeeding support to families at risk of breastfeeding difficulties delivering at Slagelse Hospital across healthcare sectors including obstetric and neonatal departments primary care and civil society
The study aims to develop implement and evaluate a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand Denmark
Potentially results can help reducing inequality in health thus more families achieve exclusive breastfeeding and gain health benefits from breastfeeding
Detailed Description:
Background Breastfeeding is a tailored nutrition for newborn infants in their first years Breastfeeding has short and long-term positive health effects on both mothers and infants
For infants breastfeeding has a protective effect against sudden infant death respiratory gastrointestinal and ear infections obesity diabetes and childhood leukemia Breastfeeding also benefits the infants cognitive development Studies have found that breastfeeding positively affects the infants cognitive abilities and IQ For premature infants mothers own milk also protects against the potentially life-threatening disease necrotizing enterocolitis as well as reducing the risk of retinopathy of prematurity for very preterm infants
For mothers breastfeeding carries a reduced risk of type 2 diabetes breast- and ovarian cancer and reduce the risk of cardiovascular disease and benefits the mothers because it may reduce depression and stress Furthermore breastfeeding may increase a secure mother-infant attachment and improve the mothers emotional response to the infant proportionally with the duration of breastfeeding
The World Health OrganizationWHO recommends exclusive breastfeeding for six months and partially for two years or longer and has set a goal of optimizing breastfeeding in 2025 Danish Health Authorities also recommend exclusive breastfeeding for six months and partially for one year or longer
Internationally breastfeeding rates and duration has declined and Denmark is no exception Breastfeeding has a social barrier both in the early phase of initiation and in the first months in low-income as well as in high-income countries We know that breastfeeding follows a pattern of inequalities and women with less education and low socio-economic status are less likely to exclusively breastfeed
Declining rates of breastfeeding are a growing problem as exclusive breastfeeding has decreased over the last decade in all Danish regions Region Zealand is one of the regions with the lowest rate of exclusive breastfeeding when the infant is four months old compared to the rest of Denmark Even though Denmark has a relatively well developed health care system with at least formal equal access to health services inequality in health is growing especially in Region Zealand
Certain factors are known to be associated with difficulties in initiating and sustaining breastfeeding These include maternal overweight gestational diabetes delivery by cesarean section admission of the infant to Neonatal Intensive Care Unit NICU due to being small premature or sick as well as breastfeeding problems with a previous child previous operations on the breast social and economic constraints and psychosocial problems for the mother
In Denmark we have guidelines for breastfeeding counselling after uncomplicated birth We know that early interventions will change the trajectory of non-infectious diseases We lack however knowledge on how to offer differentiated care for breastfeeding mother and infant dyads with risk factors for complicated breastfeeding including how we can improve collaboration with healthcare visitors in the municipalities to make the best transition from hospital to home We do not have differentiated programs so we help the families who need help the most
Purpose and hypotheses This study aims to develop implement and assess the effect of cross-sectoral cooperation aiming to support breastfeeding in families who give birth at Slagelse Hospital and who are at high risk of complicated breastfeeding We intend to set up a new service where we provide families at high risk of complicated breastfeeding with differentiated practical counselling based on the familys needs and evidence-based knowledge
Our hypothesis is that an early differentiated and locally adapted intervention will increase the initiation rate and duration of breastfeeding among women delivering at Slagelse Hospital
The study is an independent part of an initiative at Slagelse Hospital Region Zealand aiming to reduce inequality in health among children
The study design is a clinical prospective observational cohort study The development implementation and evaluation of a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand Denmark
Aim To develop implement and evaluate a locally adapted and differentiated breastfeeding-counselling model focusing especially on families at risk of experiencing breastfeeding difficulties and therefore most likely to benefit from health-promoting efforts like breastfeeding support
Research question Will the implementation of a locally adapted intervention aimed at supporting families at high risk of complicated breastfeeding outcomes lead to an increase in the proportion of exclusively breastfed children at four months of age when compared to a cohort born before the intervention
Study design In a prospective observational design we will follow families delivering during eight months following the implementation of the intervention and compare to a control group of families delivering during eight months before the intervention
Intervention The intervention is a complex process and we will therefore use a theoretical framework for complex interventions developed by the Medical Research Council as a sustainable effort for breastfeeding requires collaboration across sectors the involvement of various health professions and the involvement of users and stakeholders from the local community
The exact design of the intervention will therefore be determined according to the results of this process
However the intervention is likely to include components described in the WHOs Baby Friendly Hospital Initiative BFHI and neonatal BFHI
We plan to stratify the intervention by identifying women at risk either at prenatal consultations during pregnancy or at birth
1 Women with low risk factors will be given the care described in Danish National Guideline for initiation of breastfeeding after an uncomplicated birth
2 Women with a moderate risk will be offered a seven day program with easy contact to the maternity ward as described by the Danish Health Authorities in the early postpartum period
3 Women with high risk will be offered a tailored intervention with an easy access to qualified breastfeeding counselling This service will be planned in co-creation with peer support groups from the organization Forældre og Fødsel midwives and nurses at the Slagelse hospital maternity ward nurses at the Slagelse hospital neonatal ward and health visitors from three municipalities in Region Zealand
Although the intervention has a specific focus on those in the highest risk it may also improve the care given to families at lower risk of breastfeeding complication by raising general awareness and improving the knowledge among health care workers
Materials and methods We will perform a prospective observational cohort study following families giving birth during the eight months before the intervention pre-cohort compared to a cohort of families giving birth during eight months after the intervention is implemented post-cohort Children born during a pilot phase of 4 months between the pre-cohort and the complete implementation of the intervention will not be included in the data collection
Participants Primarily the intervention aims at families in a target group of families at high risk of complicated breastfeeding however as the intervention may also include a general change of culture and attitude as well as a general improved training among health staff it may potentially benefit all families We will therefore collect data from all families delivering at the hospital including families in the target group and from low-risk families delivering at the hospital who give consent to participate in the study collect data
Data collection Data will be collected on all consenting families giving birth at Slagelse Hospital in the period of eight months before the intervention and one year after Consent to collect and store patient data will be obtained from families at inclusion
Data on primary and secondary outcomes will be collected through electronic questionnaires after discharge If the families do not fill out in the questionnaires themselves they will be contacted by telephone
Power and sample size estimation It is assumed that 50 of all women currently breastfeed their child for four months based on the Danish Child Database18 Showing an increase after the intervention to 57 with a power of 80 and alpha of 005 requires that we include 796 families in the control and intervention cohort This is estimated to be achievable as there are approximately 1800 births annually Slagelse Hospital This means that in 8 months there are approximately 1200 women giving birth of which 80 are expected to give consent for data collection corresponding to 960 families
For infants breastfeeding has a protective effect against sudden infant death respiratory gastrointestinal and ear infections obesity diabetes and childhood leukemia Breastfeeding also benefits the infants cognitive development Studies have found that breastfeeding positively affects the infants cognitive abilities and IQ For premature infants mothers own milk also protects against the potentially life-threatening disease necrotizing enterocolitis as well as reducing the risk of retinopathy of prematurity for very preterm infants
For mothers breastfeeding carries a reduced risk of type 2 diabetes breast- and ovarian cancer and reduce the risk of cardiovascular disease and benefits the mothers because it may reduce depression and stress Furthermore breastfeeding may increase a secure mother-infant attachment and improve the mothers emotional response to the infant proportionally with the duration of breastfeeding
The World Health OrganizationWHO recommends exclusive breastfeeding for six months and partially for two years or longer and has set a goal of optimizing breastfeeding in 2025 Danish Health Authorities also recommend exclusive breastfeeding for six months and partially for one year or longer
Internationally breastfeeding rates and duration has declined and Denmark is no exception Breastfeeding has a social barrier both in the early phase of initiation and in the first months in low-income as well as in high-income countries We know that breastfeeding follows a pattern of inequalities and women with less education and low socio-economic status are less likely to exclusively breastfeed
Declining rates of breastfeeding are a growing problem as exclusive breastfeeding has decreased over the last decade in all Danish regions Region Zealand is one of the regions with the lowest rate of exclusive breastfeeding when the infant is four months old compared to the rest of Denmark Even though Denmark has a relatively well developed health care system with at least formal equal access to health services inequality in health is growing especially in Region Zealand
Certain factors are known to be associated with difficulties in initiating and sustaining breastfeeding These include maternal overweight gestational diabetes delivery by cesarean section admission of the infant to Neonatal Intensive Care Unit NICU due to being small premature or sick as well as breastfeeding problems with a previous child previous operations on the breast social and economic constraints and psychosocial problems for the mother
In Denmark we have guidelines for breastfeeding counselling after uncomplicated birth We know that early interventions will change the trajectory of non-infectious diseases We lack however knowledge on how to offer differentiated care for breastfeeding mother and infant dyads with risk factors for complicated breastfeeding including how we can improve collaboration with healthcare visitors in the municipalities to make the best transition from hospital to home We do not have differentiated programs so we help the families who need help the most
Purpose and hypotheses This study aims to develop implement and assess the effect of cross-sectoral cooperation aiming to support breastfeeding in families who give birth at Slagelse Hospital and who are at high risk of complicated breastfeeding We intend to set up a new service where we provide families at high risk of complicated breastfeeding with differentiated practical counselling based on the familys needs and evidence-based knowledge
Our hypothesis is that an early differentiated and locally adapted intervention will increase the initiation rate and duration of breastfeeding among women delivering at Slagelse Hospital
The study is an independent part of an initiative at Slagelse Hospital Region Zealand aiming to reduce inequality in health among children
The study design is a clinical prospective observational cohort study The development implementation and evaluation of a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand Denmark
Aim To develop implement and evaluate a locally adapted and differentiated breastfeeding-counselling model focusing especially on families at risk of experiencing breastfeeding difficulties and therefore most likely to benefit from health-promoting efforts like breastfeeding support
Research question Will the implementation of a locally adapted intervention aimed at supporting families at high risk of complicated breastfeeding outcomes lead to an increase in the proportion of exclusively breastfed children at four months of age when compared to a cohort born before the intervention
Study design In a prospective observational design we will follow families delivering during eight months following the implementation of the intervention and compare to a control group of families delivering during eight months before the intervention
Intervention The intervention is a complex process and we will therefore use a theoretical framework for complex interventions developed by the Medical Research Council as a sustainable effort for breastfeeding requires collaboration across sectors the involvement of various health professions and the involvement of users and stakeholders from the local community
The exact design of the intervention will therefore be determined according to the results of this process
However the intervention is likely to include components described in the WHOs Baby Friendly Hospital Initiative BFHI and neonatal BFHI
We plan to stratify the intervention by identifying women at risk either at prenatal consultations during pregnancy or at birth
1 Women with low risk factors will be given the care described in Danish National Guideline for initiation of breastfeeding after an uncomplicated birth
2 Women with a moderate risk will be offered a seven day program with easy contact to the maternity ward as described by the Danish Health Authorities in the early postpartum period
3 Women with high risk will be offered a tailored intervention with an easy access to qualified breastfeeding counselling This service will be planned in co-creation with peer support groups from the organization Forældre og Fødsel midwives and nurses at the Slagelse hospital maternity ward nurses at the Slagelse hospital neonatal ward and health visitors from three municipalities in Region Zealand
Although the intervention has a specific focus on those in the highest risk it may also improve the care given to families at lower risk of breastfeeding complication by raising general awareness and improving the knowledge among health care workers
Materials and methods We will perform a prospective observational cohort study following families giving birth during the eight months before the intervention pre-cohort compared to a cohort of families giving birth during eight months after the intervention is implemented post-cohort Children born during a pilot phase of 4 months between the pre-cohort and the complete implementation of the intervention will not be included in the data collection
Participants Primarily the intervention aims at families in a target group of families at high risk of complicated breastfeeding however as the intervention may also include a general change of culture and attitude as well as a general improved training among health staff it may potentially benefit all families We will therefore collect data from all families delivering at the hospital including families in the target group and from low-risk families delivering at the hospital who give consent to participate in the study collect data
Data collection Data will be collected on all consenting families giving birth at Slagelse Hospital in the period of eight months before the intervention and one year after Consent to collect and store patient data will be obtained from families at inclusion
Data on primary and secondary outcomes will be collected through electronic questionnaires after discharge If the families do not fill out in the questionnaires themselves they will be contacted by telephone
Power and sample size estimation It is assumed that 50 of all women currently breastfeed their child for four months based on the Danish Child Database18 Showing an increase after the intervention to 57 with a power of 80 and alpha of 005 requires that we include 796 families in the control and intervention cohort This is estimated to be achievable as there are approximately 1800 births annually Slagelse Hospital This means that in 8 months there are approximately 1200 women giving birth of which 80 are expected to give consent for data collection corresponding to 960 families
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None