Status:
COMPLETED
Coached, Coordinated, Enhanced Neonatal Transition (CCENT)
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
Children's Hospital of Eastern Ontario
Conditions:
Prematurity
Eligibility:
All Genders
Up to 4 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria (meets at least one of the following criteria):
- Infant born ≤ 26+6 weeks of gestational age (GA)
- 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
- 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.
- Infant with hypoxic ischemic encephalopathy (HIE) requiring therapeutic hypothermia and in the recruiting institution for ≥ 14 days.
- Exclusion Criteria:
- Families that do not speak English or French
- Parent will not be involved with child's care over the entirety of the study period (2 years) (e.g., adoption).
- 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.
- Infant that has previously been discharged home from the NICU/hospital.
- Decision/high likelihood of decision for act of withdrawal of care by clinical teams/families
Exclusion
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT03350243
Start Date
January 31 2018
End Date
October 31 2022
Last Update
April 13 2023
Active Locations (7)
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1
BC Children's Hospital and BC Women's Hospital & Health Centre
Vancouver, British Columbia, Canada
2
Children's Hospital Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
4
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8