NCT03460496

Transition to Home (TtH) After Preterm Birth

Status unknown NA Last updated 3 April 2019

What this trial tests

NA trial testing neonatologists in Preterm Birth in 36 participants. Status unknown.

Timeline

1 February 2018

Primary endpoint
30 April 2019

31 December 2019

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	36
Start date	1 February 2018
Primary completion	30 April 2019
Estimated completion	31 December 2019
Sites	1 location across Switzerland

Drugs / interventions tested

• neonatologists
• psychological support
• lactation consultant
• physiotherapeutic interventions
• social workers
• music therapy
• other health care professionals
• interprofessional roundtable meetings
• Advanced practice nurses' interventions

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

Adults 24 Weeks to 35 Weeks, any sex, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of a Model of Transitional Care After Preterm Birth on Parents' Mental Health and Self-Efficacy: A Randomized Controlled Pilot Trial.
   Schuetz Haemmerli N, Stoffel L, Schmitt KU, Humpl T, et al · · 2024 · cited 1× · PMID 39457225 · DOI 10.3390/children11101260