NCT03350243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4.2 years

First QC Date

November 1, 2017

Last Update Submit

April 11, 2023

Conditions

Prematurity

Keywords

Neonatal Intensive Care UnitMindfulnessCare coordinationAnticipatory guidanceParental supportNeonatal follow-upAcceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Parental Stress

    This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.

    12 months

Secondary Outcomes (20)

  • Parental Quality of Life (QoL)

    4 months

  • Parental Quality of Life (QoL)

    12 months

  • Parental Empowerment

    12 months

  • Child Social and Emotional Development

    12 months

  • Parent and Child Interaction

    12 months

  • +15 more secondary outcomes

Other Outcomes (2)

  • Health System Outcomes

    12 months

  • Social support

    Baseline

Study Arms (2)

CCENT Intervention group

EXPERIMENTAL

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.

Other: CCENT Intervention

Control group

NO INTERVENTION

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

Interventions

CCENT InterventionOTHER

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.

CCENT Intervention group

Eligibility Criteria

Age0 Months - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

BC Children's Hospital and BC Women's Hospital & Health Centre

Vancouver, British Columbia, Canada

Location

Children's Hospital Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

McGill University Health Centre/Montreal Children's Hospital

Montreal, Quebec, Canada

Location

The Ottawa Hospital

Ottawa, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34233983DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Julia Orkin, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Medical Director of the Complex Care Program

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 22, 2017

Study Start

January 31, 2018

Primary Completion

March 31, 2022

Study Completion

October 31, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(7)