Status:

UNKNOWN

Family Integrated Care in the NICU

Lead Sponsor:

Mount Sinai Hospital, Canada

Collaborating Sponsors:

Foothills Medical Centre

Sunnybrook Health Sciences Centre

Conditions:

Premature Birth

Eligibility:

All Genders

Up to 33 years

Phase:

NA

Brief Summary

In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this i...

Eligibility Criteria

Inclusion

  • \< 33 weeks gestational age at birth;
  • On no respiratory support or low level respiratory support (i.e., oxygen by cannula or mask, or continuous positive airway pressure (CPAP);
  • A primary caregiver parent who is willing and able to commit to spending at least 8 hours per day with her/his infant between the hours of 0700 and 2000;
  • Parental consent.

Exclusion

  • Palliative care;
  • Major life threatening congenital anomaly;
  • Critical illness (unlikely to survive);
  • On high level of respiratory support (mechanical ventilator, high frequency oscillatory or jet ventilation, extra-corporeal membrane oxygenation)
  • Parental request for early transfer to another hospital;
  • Parental inability to participate (e.g., health, social or language issues that might inhibit their ability to communicate with the healthcare team).

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2017

Estimated Enrollment :

720 Patients enrolled

Trial Details

Trial ID

NCT01852695

Start Date

March 1 2013

End Date

March 1 2017

Last Update

October 4 2016

Active Locations (15)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (15 locations)

1

Foothills Medical Centre

Calgary, Alberta, Canada

2

Health Sciences Centre, Winnipeg

Winnipeg, Manitoba, Canada

3

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

4

The Moncton Hospital

Moncton, New Brunswick, Canada