Family Integrated Care in the NICU

Premature Birth Clinical Trial

— FICare  

Official title:

A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01852695
• Other study ID #: 122173
• Status: Active, not recruiting
• Phase: N/A
• First received: December 19, 2012
• Last updated: October 3, 2016
• Start date: March 2013
• Est. completion date: March 2017

Study information

• Verified date: October 2015
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 720
• Est. completion date: March 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 33 Weeks

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Centre hospitalier universitaire de Québec	Laval	Quebec
Canada	London Health Sciences Centre	London	Ontario
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Regina General Hospital	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Windsor Regional Hospital	Windsor	Ontario
Canada	Health Sciences Centre, Winnipeg	Winnipeg	Manitoba
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (19)

Lead Sponsor

Collaborator

Mount Sinai Hospital, Canada

Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre Hospitalier Universitaire de Québec, CHU de Québec, Foothills Medical Centre, Hamilton Health Sciences Corporation, Health Sciences Centre, Winnipeg, Manitoba, Horizon Health Network, IWK Health Centre, Janeway Hospital, Kingston General Hospital, London Health Sciences Centre, Regina General Hospital, Royal University Hospital Foundation, St. Boniface General Hospital Research Centre, Sunnybrook Health Sciences Centre, The Hospital for Sick Children, The Moncton Hospital, Victoria General Hospital, Windsor Regional Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain	Change in weight from enrollment to day 21 following commencement of the intervention	Day 0-21	No
Secondary	Weight gain velocity	Weight gain velocity at 21 days post-intervention commencement;	Day 0-21	No
Secondary	Breastfeeding rate	Participants will be followed until first discharge home from hospital, an expected average 13 weeks	up to 16 weeks	No
Secondary	Clinical outcomes (mortality and Nosocomial infection (NI), Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia(BPD), Retinopathy of prematurity(ROP) & Intraventricular haemorrhage(IVH)	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.	up to 16 weeks	No
Secondary	Safety	Number of critical incident reports/1000 patient days	1000 patient days	Yes
Secondary	Parental stress and anxiety	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	Day 0 and when the infant reaches 35 weeks corrected gestational age	No
Secondary	Resource Use	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.	Day 0 -week 16	No