Coached, Coordinated, Enhanced Neonatal Transition (CCENT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CCENT Intervention group

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.

Group Type EXPERIMENTAL

CCENT Intervention

Intervention Type OTHER

1. Acceptance and Commitment Therapy approach: engaging families through structured individual or group sessions within the NICU and continue this support once discharged.
2. Care coordination: supporting providers in clear communication when liaising across various levels of care as well as supporting families in system and resource navigation.
3. Anticipatory guidance: proactive education targeting normal challenges in caring for a child who required intensive care support.

Control group

Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CCENT Intervention

1. Acceptance and Commitment Therapy approach: engaging families through structured individual or group sessions within the NICU and continue this support once discharged.
2. Care coordination: supporting providers in clear communication when liaising across various levels of care as well as supporting families in system and resource navigation.
3. Anticipatory guidance: proactive education targeting normal challenges in caring for a child who required intensive care support.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

0 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No