Clinical trial NCT03357458: Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age
Official title: Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age: Effectiveness of a Cluster Randomized Controlled Trial of Family Integrated Care in Level II NICUs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Prematurity
Infant,Premature
Infant Development
Child Development
Parent-Child Relations
Mental Health Wellness 1
Keywords: Family Integrated Care
Parenting education
Nursing
Cost effectiveness
Patient engagement
Randomized controlled trial
Neonatal intensive care unit
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital Research Institute
First posted: 2017-11-30
Enrollment: 56
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of care for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU).

This follow-up study will enroll infants at 6 months CA (± 1 month) recruited to the original FICare randomized controlled trial (clinicaltrials.gov ID: NCT02879799) from four level II NICU sites; two intervention and two control.

Detailed description: The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). FICare is a psycho-educational intervention that empowers parents (mothers and fathers) to sequentially build their knowledge, skill, and confidence so the family is well-prepared to care for their preterm infant before discharge. FICare is dynamic, whereby parents and healthcare providers openly and mutually negotiate equitable caregiving roles during the infant's NICU stay. Parents are educated and coached to provide routine non-medical care. Healthcare providers continue to provide medical and technical care, such as intravenous medications and procedures, legal documentation, and professional support for families. Using a cluster randomized controlled trial (cRCT), our team is evaluating FICare in all 10 Level II NICUs in Alberta (5 intervention, 5 control sites; stratified by hospital size) with follow-up of infant development and costs at age 2 months corrected age (CA). Unless otherwise indicated, infant ages are corrected for prematurity. For the cRCT, we hypothesized that FICare would reduce length of NICU stay by 10%, reduce infant morbidities (e.g., nosocomial infections, respiratory support, feeding problems), increase breast-milk feeding, reduce maternal psychological distress, and reduce costs to the health care system and families. Maternal and infant data are currently being collected (1) shortly after admission to the NICU (baseline), (2) shortly before discharge from NICU (outcome), and (3) at 2 months CA (follow-up). At 2 months CA, our team will evaluate outcomes related to infant global development and maternal psychosocial distress. A follow-up study at 6 months CA will provide evidence of the sustainability of any effects, upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

There is currently no standardized timeline for follow-up of infants born prematurely. Follow-up at 6 months CA is appropriate as the utility of assessing development in preterm infants is questionable prior to this age, and evidence suggests that inter-individual variability in child development increases after 12 months. After 12 months, it becomes more difficult to capture parent-child interactions and environmental factors may exert a stronger influence on infant development, potentially diluting the ability to directly measure the effect of FICare.

Eligibility criteria: Inclusion Criteria:

* Mothers of infants born between 32 weeks and zero days and 34 weeks and 6 days gestation who enrolled in the FICare Alberta cluster controlled trial (cRCT) at one of four of the ten Level II NICU sites. The FICare cRCT enrolled mothers of any age who have decision making capacity; mothers who are able to speak, read and understand English well enough to provide informed consent, and complete surveys online or via telephone.

Exclusion Criteria:

* The FICare Alberta Level II NICU cRCT excluded mothers whose infants have serious congenital or chromosomal anomalies that require surgery, or are receiving palliative care; mothers who are not able to communicate in English; mothers with complex social issues.

Primary outcomes:
measure: Maternal-Child Interactions
timeFrame: At 6-months corrected age
Secondary outcomes:
measure: Infant global development
timeFrame: At 6-months corrected age
measure: Infant social and emotional development
timeFrame: At 6-months corrected age
measure: Maternal-reported infant sleep
timeFrame: At 6-months corrected age
measure: Maternal parenting self-efficacy
timeFrame: At 6-months corrected age
measure: Breastfeeding rates
timeFrame: At 6-months corrected age
measure: Number of emergency room visits
timeFrame: At 6-months corrected age
measure: Number of re-admissions to hospital
timeFrame: At 6-months corrected age
measure: Number of unplanned visits to physician or other provider
timeFrame: At 6-months corrected age
measure: Number of antibiotic prescriptions
timeFrame: At 6-months corrected age
measure: Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times).
timeFrame: At 6-months corrected age
measure: Parenting stress
timeFrame: At 6-months corrected age
measure: State Anxiety
timeFrame: At 6-months corrected age
measure: Postnatal depression risk
timeFrame: At 6-months corrected age
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References: