Study Results
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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UNKNOWN
NA
720 participants
INTERVENTIONAL
2013-03-31
2017-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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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.
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.
Control Arm
Regular care by nurse will be provided to patients admitted to control sites.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
33 Weeks
ALL
No
Sponsors
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Foothills Medical Centre
OTHER
Sunnybrook Health Sciences Centre
OTHER
London Health Sciences Centre
OTHER
St. Boniface Hospital
OTHER
CHU de Quebec-Universite Laval
OTHER
IWK Health Centre
OTHER
Hamilton Health Sciences Corporation
OTHER
The Hospital for Sick Children
OTHER
Horizon Health Network
OTHER
Regina General Hospital
OTHER
Royal University Hospital Foundation
OTHER
Windsor Regional Hospital
OTHER
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
The Moncton Hospital
UNKNOWN
Health Sciences Centre, Winnipeg, Manitoba
OTHER
Kingston Health Sciences Centre
OTHER
Victoria General Hospital
UNKNOWN
Janeway Hospital
UNKNOWN
Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Principal Investigators
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Shoo K Lee, FRCPC PhD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Health Sciences Centre, Winnipeg
Winnipeg, Manitoba, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Centre hospitalier universitaire de Québec
Laval, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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References
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Mclean MA, Scoten OC, Yu W, Ye XY, Petrie J, Church PT, Soraisham AS, Mirea LS, Weinberg J, Synnes AR, O'Brien K, Grunau RE. Lower Maternal Chronic Physiological Stress and Better Child Behavior at 18 Months: Follow-Up of a Cluster Randomized Trial of Neonatal Intensive Care Unit Family Integrated Care. J Pediatr. 2022 Apr;243:107-115.e4. doi: 10.1016/j.jpeds.2021.12.055. Epub 2021 Dec 29.
Synnes AR, Petrie J, Grunau RE, Church P, Kelly E, Moddemann D, Ye X, Lee SK, O'Brien K; Canadian Neonatal Network Investigators; Canadian Neonatal Follow-Up Network Investigators. Family integrated care: very preterm neurodevelopmental outcomes at 18 months. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):76-81. doi: 10.1136/archdischild-2020-321055. Epub 2021 Jun 18.
O'Brien K, Robson K, Bracht M, Cruz M, Lui K, Alvaro R, da Silva O, Monterrosa L, Narvey M, Ng E, Soraisham A, Ye XY, Mirea L, Tarnow-Mordi W, Lee SK; FICare Study Group and FICare Parent Advisory Board. Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial. Lancet Child Adolesc Health. 2018 Apr;2(4):245-254. doi: 10.1016/S2352-4642(18)30039-7. Epub 2018 Feb 8.
O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.
Other Identifiers
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122173
Identifier Type: -
Identifier Source: org_study_id
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