Family Integrated Care in the NICU (FICare)

Mount Sinai Hospital, Canada

Status: Unknown

Conditions: Premature Birth

Treatments: Behavioral: Family Integrated Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01852695

122173

Details and patient eligibility

About

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.

Enrollment: 720 patients

Sex: All

Ages: Under 33 weeks old

Volunteers: No Healthy Volunteers

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).

Trial design

720 participants in 2 patient groups

Family Integrated Care Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Family Integrated Care

Control Arm

No Intervention group

Description:

Regular care by nurse will be provided to patients admitted to control sites.