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CCENT Intervention for Premature Infants (CCENT Trial)

N/A
Waitlist Available
Led By Julia Orkin, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

CCENT Trial Summary

This trial will evaluate a new model of follow-up care and support for parents of infants who spent time in the Neonatal Intensive Care Unit (NICU). The model, called the Coached, Coordinated, Enhanced Neonatal Transition (CCENT), involves a key worker who provides coaching, care coordination, and education for families during the first year after their child's NICU stay. The goal is to improve the psychosocial support and medical care coordination beyond the NICU, as many of the medical and social concerns do not end at the time of discharge.

Eligible Conditions
  • Premature Infants

CCENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Parental Stress
Secondary outcome measures
Child Development
Child Social and Emotional Development
Healthcare Service Delivery
+8 more
Other outcome measures
Health System Outcomes
Social support

CCENT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CCENT Intervention groupExperimental Treatment1 Intervention
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 II: Control groupActive Control1 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.

Find a Location

Who is running the clinical trial?

MOUNT SINAI HOSPITALOTHER
40 Previous Clinical Trials
14,356 Total Patients Enrolled
The Ottawa HospitalOTHER
93 Previous Clinical Trials
62,643 Total Patients Enrolled
Montreal Children's Hospital of the MUHCOTHER
29 Previous Clinical Trials
114,336 Total Patients Enrolled

Frequently Asked Questions

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~38 spots leftby Apr 2025