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Coached, Coordinated, Enhanced Neonatal Transition (CCENT)

T

The Hospital for Sick Children

Status

Completed

Conditions

Prematurity

Treatments

Other: CCENT Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03350243
1000057100

Details and patient eligibility

About

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.

Enrollment

275 patients

Sex

All

Ages

Under 4 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

275 participants in 2 patient groups

CCENT Intervention group
Experimental group
Description:
Participants will be assigned a dedicated key worker that will support families through the child's first year, in addition to standard medical care, which involves a primary care provider and/or neonatal follow-up at routine times.
Treatment:
Other: CCENT Intervention
Control group
No Intervention group
Description:
Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times.

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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