A Cluster Randomized Controlled Trial of FICare at 18 Months

Premature Birth Clinical Trial

Official title: Child Developmental Health, Maternal Psychosocial Distress, and Health System Costs at 18 Months Corrected Age: Effectiveness of a Cluster Randomized Controlled Trial of Family Integrated Care in Level II NICUs

Status Completed

Clinical Trial Summary

In Alberta, one in every twelve babies is born preterm. Compared with their full term counterparts, preterm infants who survive are at higher risk for respiratory problems, jaundice, infections, feeding problems, behavioural problems, and neuro-developmental disabilities, including cognitive delays, and visual and hearing impairments. As a result, parents must leave their preterm babies in the hospital to fully develop enough to care for them at home. When it is time for discharge, parents are often unprepared to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The aim of this novel health services study is to assess the longer-term outcomes and costs, to 18 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). A cluster randomized controlled trial (cRCT) of FICare is currently in progress. 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. The FICare cRCT evaluates outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

Clinical Trial Description

Each year, about 15 million of the world's infants are born preterm (<37 weeks gestation), and this number is increasing. In Alberta, the preterm birth rate was 8.43% in 2015, representing 4,749 infants. Alberta has the highest rate of preterm birth among the Canadian provinces, which can be attributed, in part, to delayed child bearing and assisted reproduction. Approximately 20% of all preterm infants are born at <32 weeks GA and require care in a Level III NICU. The remaining 80% are moderate and late preterm infants, which comprises 6.6% of all live births. As gestational age (GA) decreases, the risk of chronic health problems and developmental delays increases. Compared to their full term counterparts, moderate and late preterm infants (born at 32 weeks and zero days [32 0/7] to 36 weeks and six days [36 6/7] GA) are at higher risk for poor health (e.g., increased hospitalizations, respiratory morbidities, and growth and feeding problems) and developmental outcomes (e.g., neurodevelopmental disabilities and cognitive delays, communication and language impairments, and school-related problems). Results of recent studies also indicate that moderate and late preterm infants are at greater risk of experiencing social-emotional problems. In Alberta, preterm infants represent the largest proportion of expenditures of all pediatric health care utilization at 8.45%, with a cost of approximately $35 million per year. The costs associated with preterm infants are greater than for term infants because of longer hospital stays following birth, increased resource utilization, hospital readmissions, and the need for additional health, education, and social services. Financial consequences for families of preterm infants are associated with reduced work force participation and lost earnings, specialized nutritional requirements, and learning and development supports for the child. In addition, there are unquantifiable costs associated with psychological distress, marital and family distress, and social isolation.

The aim of this novel health services research proposal is to assess the longer-term outcomes and costs, to 18 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) (clinicaltrials.gov ID: NCT02879799), the investigators are 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. Unless otherwise indicated, infant ages are corrected for prematurity. For the cRCT, investigators hypothesized that FICare would reduce length of NICU stay by 10%, reduce infant morbidities (e.g., nosocomial infections, respiratory support, feeding problems), increase breastmilk 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 (follow-up). With current funding, investigators can evaluate outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

The investigators hypothesize that compared to standard care in a Level II NICU, FICare will:

(1) improve global development of moderate and late preterm infants at 18 months (primary outcome); (2) improve infant social and emotional development; (3) reduce the frequency of child emergency department visits, hospital readmission rates, and physician visits additional to recommended health surveillance visits; (4) improve child growth trajectories; (5) decrease use of antibiotic prescriptions; (6) increase maternal confidence in caring for their child; (7) decrease maternal psychosocial distress; (8) improve maternal-reported toddler sleep, and (9) decrease public healthcare payer costs.

There is currently no standardized timeline for follow-up of infants born prematurely. Evidence suggests that 18 months is ideal for follow-up because there is decreased inter-individual variability in child development, and social-emotional outcomes can be more accurately assessed. After 18 months, environmental factors may exert a stronger influence on infant development, potentially diluting the ability to directly measure the effect of FICare. Eighteen months is the age at which Canadian Neonatal Follow-Up Network data are collected for infants admitted to a Level III NICU, which will enable comparisons of some outcomes with infants in the Level II NICU FICare Alberta cRCT. There are no plans for further follow-up past 18 months. ;

Related Conditions & MeSH terms

• Premature Birth

• NCT number: NCT03337659
• Study type: Interventional
• Source: University of Calgary
• Status: Completed
• Phase: N/A
• Start date: September 27, 2017
• Completion date: March 26, 2020