Transition to Home (TtH) After Preterm Birth
NCT03460496 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2019-04-03
Summary
Preterm birth is associated with significant and often life-long developmental, emotional and financial burdens. Preterm infants face several challenges that continue late into life, including developmental delays, social, and behavioural problems and poor academic performance. Parents also suffer considerable emotional and physical stress which in turn can have a negative impact on the child's development.
In Switzerland, during the transition from hospital to home, there are not many interventions intended to improve mental health outcomes in parents or to promote positive parenting to improve developmental outcomes for the preterm infant. There are also few interventions to reduce associated health care costs.
In order to improve parent and preterm infant outcomes, reduce hospital stay in the neonatal intensive care unit (NICU), lower readmission rates, and avoid unnecessary use of primary care resources a unique, new model of transitional care was developed. The new 'Transition to Home' (TtH) model makes use of well-tested, successful methods of post-discharge care.
The investigators' study will evaluate the organizational and financial feasibility and cost effectiveness of the TtH model for infants born preterm by measuring the impact of an Advanced Practice Nurse (APN)-led intervention at the Children's University Hospital Bern. The intervention focuses on improving parental mental health and well-being, on infant growth and development, and on lowering overall costs. The investigators will gather data and then adapt and test the model within a longitudinal interventional comparative effectiveness study, and prepare it for other Cantons in Switzerland to implement.
Conditions
Interventions
- BEHAVIORAL
-
neonatologists
will continue to be contact persons for the APN, even after hospital discharge, and will be available for 3 fixed outpatient consultations with the APN and families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician.
- BEHAVIORAL
-
psychological support
Psychological support will be standard for all families. In a first consultation, psychologist and family will decide about long-term psychological support. They will have at least 3 follow-up consultations during hospital stay and one before discharge; specific psychological interventions will be provided. The aim of the interventions is to re-establish emotional stability and improve the ability of parents to cope with the situation, to prevent parental and family adaptive disorders and child developmental disorders. Support focus on screening for psychological disorders. Techniques include family-centred, holistic interventions (e.g. activating parental resources and coping, crisis intervention, stabilization techniques etc.). Parents will receive outpatient psychological support.
- BEHAVIORAL
-
lactation consultant
during hospitalization, the lactation consultant will be involved more frequently than during standard care. Breastfeeding support will take a structured approach and will be performed in close collaboration with both parents. The main aims of structured breastfeeding support are strengthen parent-child bonding. Infants will be breastfed according to their needs. Parents will become competent in meeting their child's nutritional needs. After discharge, parents may schedule outpatient breastfeeding consultations.
- BEHAVIORAL
-
physiotherapeutic interventions
physiotherapeutic interventions will also be structured. The physiotherapist will make an assessment during hospitalization, and decide which physiotherapeutic interventions are necessary. Each family will learn how to handle their premature child in everyday life, based on the child's developmental stage, in a single consultation.
- BEHAVIORAL
-
social workers
social workers will closely collaborate with the APN within the transitional model. They will be involved with every family and will assist the APN in establishing a network with social and medical services within and outside the clinic. They will also support families in coping with daily life and with their integration into society, family and work. Furthermore, they will give advice on social security issues and on asserting claims as well as clarify financial possibilities.
- BEHAVIORAL
-
music therapy
music therapy with premature infants and their parents creates a new dimension of contact, and helps stabilize the child and supports their development through music. It also reduces the anxiety of parents, and enhances self-efficacy and makes them more sensitive to their child 74,75, thus enhancing the parent-child relationship. In standard care, music therapy is offered only during hospitalization. In the new model of care, after NICU discharge, the program will offer 10 follow-up sessions at the family's home or in the music therapists' private practice.
- BEHAVIORAL
-
other health care professionals
the APN will contact and involve other health care professionals, like the family's paediatrician, the outpatient midwife, the community health care nurse or the mother and father counselling as soon as need becomes evident. The APN will help set up meetings between health care professionals and the family, and will keep them up-to-date on the family's situation.
- BEHAVIORAL
-
interprofessional roundtable meetings
interprofessional roundtable meetings with health care professionals involved in the care of a specific family will be held every two weeks. The meeting is aimed at developing consensus on the best possible support in the care of preterm infants and their families. Parents will be invited to participate in these meetings, led by the APN. The meeting will focus on two family situations, and then determine and initiate supportive interventions in collaboration with the parents.
- BEHAVIORAL
-
Advanced practice nurses' interventions
The APN will participate in comprehensively planning individual discharge, coordinating services, consulting with other healthcare professionals, assessing needs on a case by case basis, and coaching the family from birth to 6 months after discharge from the NICU. The APN will provide the Newborn Behavioral Observation (NBO), an infant-centred and family-focused method for building relationships, to parents and children, during and after hospitalization. The NBO helps sensitize parents to their infant's competencies and capabilities, teaching them to read their infant's signals and understand their behaviours. It promotes positive interactions between parent and preterm infant. The APN will also offer telephone support and follow-up Visits at home after discharge.
Sponsors & Collaborators
-
Bern University of Applied Sciences
collaborator OTHER -
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
Mathias Nelle, PD · Insel Gruppe AG, University Hospital Bern
-
Eva Cignacco, PD · Bern University of Applied Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 24 Weeks
- Max Age
- 35 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-02-01
- Primary Completion
- 2019-04-30
- Completion
- 2019-12-31
Countries
- Switzerland
Study Locations
More Related Trials
-
Impact of an Intervention Program on Parenting Stress After Preterm Birth
NCT02394444 ·Status: COMPLETED ·Phase: NA
-
Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality
NCT06224764 ·Status: RECRUITING ·Phase: NA
-
Home Support for Mothers Whose Premature Infants
NCT04741672 ·Status: COMPLETED ·Phase: NA
-
E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
NCT06939192 ·Status: RECRUITING ·Phase: NA
-
Early Family Based Intervention in Preterm Infants
NCT02415530 ·Status: COMPLETED ·Phase: NA
-
Parental Stress and Attachment in Preterm Infants
NCT06813560 ·Status: NOT_YET_RECRUITING
-
Adolescents Born Preterm; Nurtured Beginnings
NCT00310869 ·Status: UNKNOWN ·Phase: NA
-
Effect of Support for Low-Income Mothers of Preterm Infants
NCT06362798 ·Status: RECRUITING ·Phase: NA
-
The Effectiveness of Audiovisual Intervention
NCT06525142 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond
NCT04118751 ·Status: UNKNOWN
-
Educational/Behavioral Intervention Program for Parents of Premature Infants
NCT00120614 ·Status: COMPLETED ·Phase: NA
-
Impact of Preterm Birth on Symptoms of Anxiety and Depression in Parents, and on the Precursors of Cognition, Including Social Cognition in Their Child
NCT05734768 ·Status: RECRUITING
-
Guided Participation Discharge Program for Very Preterm Infants
NCT03668912 ·Status: COMPLETED ·Phase: NA
-
Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates
NCT02803866 ·Status: UNKNOWN
-
Incubator Weaning of Moderately Preterm Infants
NCT02160002 ·Status: COMPLETED ·Phase: NA
-
Feeding and Transition to Home for Preterms at Social Risk
NCT02041923 ·Status: COMPLETED ·Phase: NA
-
A Longitudinal Study of Effectiveness of Early Intervention for Preterm Infants
NCT00946244 ·Status: COMPLETED
-
Weaning Preterm Infants at 1500 Grams From Incubators
NCT01083303 ·Status: COMPLETED ·Phase: NA
-
Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
NCT03668626 ·Status: COMPLETED ·Phase: NA
-
Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
NCT04932044 ·Status: COMPLETED ·Phase: NA
-
FAcilitating Safe Transition to Home for Preterm Infants: an Observational Study
NCT05609305 ·Status: ACTIVE_NOT_RECRUITING
-
Reproducibility of a New Practical Newborn Behavioral Observation Scale
NCT02844205 ·Status: UNKNOWN
-
Development, ADL, Participation, and Quality of Life in Preterm Infants: Longitudinal Research
NCT06532695 ·Status: RECRUITING
-
Early Intervention in Preterm Infants: Short and Long Term Developmental Outcome After a Parental Training Program
NCT02983513 ·Status: COMPLETED ·Phase: NA
-
Early Weaning From Incubator To Crib
NCT06230172 ·Status: RECRUITING ·Phase: NA