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Family Integrated Care in the NICU (FICare)

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ClinicalTrials.gov Identifier: NCT01852695
Recruitment Status : Unknown
Verified October 2015 by Mount Sinai Hospital, Canada.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : October 4, 2016
Sponsor:
Collaborators:
Foothills Medical Centre
Sunnybrook Health Sciences Centre
London Health Sciences Centre
St. Boniface Hospital
CHU de Quebec-Universite Laval
IWK Health Centre
Hamilton Health Sciences Corporation
The Hospital for Sick Children
Horizon Health Network
Regina General Hospital
Royal University Hospital Foundation
Windsor Regional Hospital
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
The Moncton Hospital
Health Sciences Centre, Winnipeg, Manitoba
Kingston Health Sciences Centre
Victoria General Hospital
Janeway Hospital
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Tracking Information
First Submitted Date  ICMJE December 19, 2012
First Posted Date  ICMJE May 14, 2013
Last Update Posted Date October 4, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
Weight Gain [ Time Frame: Day 0-21 ]
Change in weight from enrollment to day 21 following commencement of the intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
  • Weight gain velocity [ Time Frame: Day 0-21 ]
    Weight gain velocity at 21 days post-intervention commencement;
  • Breastfeeding rate [ Time Frame: up to 16 weeks ]
    Participants will be followed until first discharge home from hospital, an expected average 13 weeks
  • Clinical outcomes (mortality and Nosocomial infection (NI), Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia(BPD), Retinopathy of prematurity(ROP) & Intraventricular haemorrhage(IVH) [ Time Frame: up to 16 weeks ]
    Patients will be followed for the duration of their hospital stay for an expected average of 13 weeks. Mortality and five major morbidities: (a) Nosocomial infection will be defined using the Center for Disease Control criteria; (b) Necrotizing enterocolitis is defined using Bell's criteria;(c) Bronchopulmonary dysplasia is defined according to Shennan et al; (d) Intraventricular hemorrhage will be classified using the Canadian Pediatric Society classification, from cranial ultrasound performed during the first 28 days of life; (e) Retinopathy of prematurity will be staged according to the International Classification of Retinopathy of Prematurity.
  • Safety [ Time Frame: 1000 patient days ]
    Number of critical incident reports/1000 patient days
  • Parental stress and anxiety [ Time Frame: Day 0 and when the infant reaches 35 weeks corrected gestational age ]
    We will administer questionnaires to parents in the first week following admission and when their infant reaches 35 weeks corrected gestational age, in both the intervention and control sites
  • Resource Use [ Time Frame: Day 0 -week 16 ]
    Data on health care utilisation will be collected during the patients entire hospital stay until the first discharge home, averaging 13 weeks including length of stay, duration of oxygen therapy. Per diem costs will be used to estimate potential cost savings derived from any reduced length of stay.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family Integrated Care in the NICU
Official Title  ICMJE A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial
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 impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5.

In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff [personal communication, Levin,A.]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Premature Birth
Intervention  ICMJE Behavioral: Family Integrated Care
Parents are integrated into the care of their infants in the NICU. Parents consent to spending up to eight hours a day with their infant, attend special education sessions, participate in daily medical rounds, and do basic infant charting. This will enable parents to provide care for infants with nursing supervision in the areas of feeding, bathing, dressing and holding skin to skin.
Study Arms  ICMJE
  • Experimental: Family Integrated Care Arm
    Parents are integrated into the care of their infants in the NICU. Parents consent to spending up to eight hours a day with their infant, attend special education sessions, participate in daily medical rounds, and do basic infant charting. This will enable parents to provide care for infants with nursing supervision in the areas of feeding, bathing, dressing and holding skin to skin.
    Intervention: Behavioral: Family Integrated Care
  • No Intervention: Control Arm
    Regular care by nurse will be provided to patients admitted to control sites.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 19, 2015)
720
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2013)
675
Estimated Study Completion Date  ICMJE March 2017
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • < 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 Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 33 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852695
Other Study ID Numbers  ICMJE 122173
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mount Sinai Hospital, Canada
Study Sponsor  ICMJE Mount Sinai Hospital, Canada
Collaborators  ICMJE
  • Foothills Medical Centre
  • Sunnybrook Health Sciences Centre
  • London Health Sciences Centre
  • St. Boniface Hospital
  • CHU de Quebec-Universite Laval
  • IWK Health Centre
  • Hamilton Health Sciences Corporation
  • The Hospital for Sick Children
  • Horizon Health Network
  • Regina General Hospital
  • Royal University Hospital Foundation
  • Windsor Regional Hospital
  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke
  • The Moncton Hospital
  • Health Sciences Centre, Winnipeg, Manitoba
  • Kingston Health Sciences Centre
  • Victoria General Hospital
  • Janeway Hospital
Investigators  ICMJE
Principal Investigator: Shoo K Lee, FRCPC PhD MOUNT SINAI HOSPITAL
PRS Account Mount Sinai Hospital, Canada
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP