Clinical trial NCT03350243: Coached, Coordinated, Enhanced Neonatal Transition (CCENT)
Official title: Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: Neonatal Intensive Care Unit
Mindfulness
Care coordination
Anticipatory guidance
Parental support
Neonatal follow-up
Acceptance and Commitment Therapy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Children's Hospital of Eastern Ontario
name: MOUNT SINAI HOSPITAL
name: The Ottawa Hospital
name: Montreal Children's Hospital of the MUHC
name: Provincial Health Services Authority
First posted: 2017-11-22
Enrollment: 275
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate a new neonatal follow-up model that offers additional support and coping resources for parents during their child's NICU admission as well as during their transition home. The Coached, Coordinated, Enhanced Neonatal Transition (CCENT) model involves a key worker who will be the primary support for families during the first year of their child's life. The key worker's role involves 1) parental coaching using an Acceptance and Commitment Therapy approach, 2) coordinating care across various levels of care as well as supporting families in system and resource navigation, and 3) provided proactive education targeting normal challenges in caring for a child who required intensive care support. The goal is to improve the psychosocial support and medical care coordination beyond the neonatal intensive care unit as many of the medical and social concerns do not end at the time of discharge. Primary objective is parent stress at 12 months.


Eligibility criteria: Inclusion Criteria (meets at least one of the following criteria):

1. Infant born ≤ 26+6 weeks of gestational age (GA)
2. Infant born between 27-29+6 weeks GA with ≥ 1 of the following risk factors:

   i)≥ Grade III intraventricular hemorrhage with post hemorrhagic hydrocephalus ii)Retinopathy of prematurity requiring intraocular bevacizumab/ anti-vascular endothelial growth factor or laser surgery therapy iii)Requires invasive (e.g., intubated) or non-invasive (e.g., CPAP or BiPAP) at ≥ 34 weeks GA and/or supplemental oxygen at ≥ 37 weeks gestational age iv)Requires surgery for management of necrotizing enterocolitis (NEC)- stage 3
3. Infant with ≥ 2 major congenital anomalies as defined by EUROCAT(13) (e.g., congenital heart disease, spina bifida, cleft palate, etc. Not including minor congenital anomalies, e.g., dysmorphic facies), and length of stay in recruiting institution ≥ 14 days.
4. Infant with hypoxic ischemic encephalopathy (HIE) requiring therapeutic hypothermia and in the recruiting institution for ≥ 14 days.

Exclusion Criteria:

1. Families that do not speak English or French
2. Parent will not be involved with child's care over the entirety of the study period (2 years) (e.g., adoption).
3. Infant will be followed by an out-of-province neonatal follow-up program or lives a significant distance from the neonatal follow up program and therefore not routinely followed by the team.
4. Infant that has previously been discharged home from the NICU/hospital.
5. Decision/high likelihood of decision for act of withdrawal of care by clinical teams/families

Primary outcomes:
measure: Change in Parental Stress
timeFrame: 12 months
Secondary outcomes:
measure: Parental Quality of Life (QoL)
timeFrame: 4 months
measure: Parental Quality of Life (QoL)
timeFrame: 12 months
measure: Parental Empowerment
timeFrame: 12 months
measure: Child Social and Emotional Development
timeFrame: 12 months
measure: Parent and Child Interaction
timeFrame: 12 months
measure: Maternal Depression
timeFrame: 6 weeks
measure: Maternal Depression
timeFrame: 4 months
measure: Maternal Depression
timeFrame: 12 months
measure: Child Development
timeFrame: 18 months
measure: Healthcare Service Delivery
timeFrame: 12 months
measure: Maternal Anxiety
timeFrame: 4 months
measure: Maternal Anxiety
timeFrame: 12 months
measure: Resource Utilization
timeFrame: 4 months
measure: Resource Utilization
timeFrame: 12 months
measure: Psychology Inflexibility
timeFrame: 6 weeks
measure: Psychology Inflexibility
timeFrame: 4 months
measure: Psychology Inflexibility
timeFrame: 12 months
measure: Psychology Inflexibility
timeFrame: 18 months
measure: Child Development
timeFrame: 18 months
measure: Parental perception of transition experience
timeFrame: 6 weeks post discharge
Other outcomes:
measure: Health System Outcomes
timeFrame: 12 months
measure: Social support
timeFrame: Baseline
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital and BC Women's Hospital & Health Centre
state: British Columbia
city: Ottawa
country: Canada
facility: Children's Hospital Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre/Montreal Children's Hospital
state: Quebec
city: Ottawa
country: Canada
facility: The Ottawa Hospital
Study officials:
affiliation: The Hospital for Sick Children
name: Julia Orkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orkin J, Major N, Esser K, Parmar A, Couture E, Daboval T, Kieran E, Ly L, O'Brien K, Patel H, Synnes A, Robson K, Barreira L, Smith WL, Rizakos S, Willan AR, Yaskina M, Moretti ME, Ungar WJ, Ballantyne M, Church PT, Cohen E. Coached, Coordinated, Enhanced Neonatal Transition (CCENT): protocol for a multicentre pragmatic randomised controlled trial of transition-to-home support for parents of high-risk infants. BMJ Open. 2021 Jul 7;11(7):e046706. doi: 10.1136/bmjopen-2020-046706.