Preterm Birth Clinical Trial
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
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.
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.
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