Clinical trial NCT05286983: Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project
Official title: Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Family Centered Care
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: University of Ulm
First posted: 2022-03-18
Enrollment: 495
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of inborn and outborn preterm infants of ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g who are admitted to the Level 3 NICU and their parents

Brief summary: This prospective single centre longitudinal cohort study enrols preterm infants ≤32+0 weeks of gestation and/or birthweight ≤1500g and their parents. Following a baseline period additional Family Centred Care elements are introduced as potentially better practices, these elements focus on four areas: the NICU (Neonatal Intensive Care Unit) environment, staff training, parental education and psychosocial support to the families. The effect of the implementation of additional Family Centred Care elements on infant, parent and staff outcomes are assessed. The parallel data collection enables to study the interrelation between these three important areas of research.

Detailed description: Background: The therapeutic advances and progress in the care for preterm infants have enabled the regular survival of more and more immature infants. However, the high burden of lifelong sequelae following premature delivery constitutes an ongoing challenge and psychomotor disorders and neurobehavioral difficulties persist into adulthood. Regardless of premature delivery, parental mental health and a healthy parent-child relationship were identified as essential prerogatives for normal infant development. Family centered care (FCC) supports preterm infants and their families by respecting the particular developmental, social and emotional needs in the NICU. Due to the large variations in concepts and goals of different FCC initiatives, scientific data on the benefits of FCC for the infant and family outcome are sparse and its effects on the clinical team need to be elaborated.

Methods: This prospective longitudinal single-center cohort study will enroll preterm infants with a gestational length of ≤32+0 weeks and/or a birth weight of ≤1500 g and their parents. After a baseline period, additional FCC elements will be introduced gradually every 6 months, covering staff training, parent education, psychosocial support for families, and last but not least, the neonatal intensive care unit environment. Recruitment will occur over a 5.5-year period, and outcomes will be tracked through periodic follow-up until 24 month of corrected age. Sample size calculation is based on corrected gestational age at discharge as the primary outcome. Secondary outcomes in infants include morbidities and treatment aspects of prematurity such as somatic growth, duration of ventilatory support, and psychomotor development. Parental outcomes relate to success of parenting education and skills, parent-family interaction, parental satisfaction, and mental health with particular emphasis on anxiety, depression, and stress. Staffing issues are addressed with special attention to the job satisfaction item. Quality improvement steps are monitored using the Plan-Do-Study-Act (PDSA) cycle method, and outcome measures address the child, parent, and medical team as they are inextricably linked. Parallel data collection allows for the interrelationship between these three important research areas to be examined.

Discussion: It is scientifically impossible to allocate improvements in outcome measures to individual enhancement steps of FCC that constitutes a continuous change in NICU culture and attitudes covering diverse areas of change. Therefore, our trial is designed to allocate childhood, parental and staff outcome measures during the stepwise changes introduced by a FCC intervention program. But even if no positive outcome measures can be confirmed, the successful execution of our standardized statistical process control method approach is suited to guide quality improvement in future studies in neonatology and beyond.

Eligibility criteria: Inclusion Criteria:

* ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
* biparental (or guardian) written informed consent

Exclusion Criteria:

* severe congenital anomalies (e.g. cyanotic heart disease, severe lung hypoplasia, congenital diaphragmatic hernia)
* decision not to provide full life support
* decision for palliative care before study entry
* parents with severe psychiatric disease

Primary outcomes:
measure: Length of hospital stay
timeFrame: 5.5years
Secondary outcomes:
measure: Key neonatal morbidities
timeFrame: 5.5years
measure: Weight gain
timeFrame: 5.5years
measure: Weight Z-Score
timeFrame: 5.5years
measure: Weight
timeFrame: 5.5years
measure: Length Z-Score
timeFrame: 5.5years
measure: Length
timeFrame: 5.5years
measure: Head Circumference Z-Score
timeFrame: 5.5years
measure: Head Circumference
timeFrame: 5.5years
measure: Full enteral feeds
timeFrame: 5.5 years
measure: Length of tube feeding
timeFrame: 5.5 years
measure: First Breastmilk Feed
timeFrame: 5.5years
measure: Breastmilk Nutrition
timeFrame: 5.5years
measure: Fully Breastfed
timeFrame: 5.5years
measure: Breastfeeding at Discharge
timeFrame: 5.5years
measure: Mechanical ventilation
timeFrame: 5.5years
measure: End of parenteral nutrition (PN)
timeFrame: 5.5years
measure: Family room
timeFrame: 5.5years
measure: Neurodevelopment at 12 months corrected age
timeFrame: 7.5years
measure: Neurodevelopmental outcome at 24 months corrected age
timeFrame: 7.5years
measure: Motor Developmental outcome at 24 months corrected age
timeFrame: 7.5years
measure: Parental Anxiety
timeFrame: 5.5years
measure: Parental Depression
timeFrame: 5.5years
measure: Parental Stress
timeFrame: 5.5years
measure: Parental Satisfaction
timeFrame: 5.5years
measure: Parental Skills
timeFrame: 5.5years
measure: Parental Visiting Hours
timeFrame: 5.5years
measure: Degree of Family Centred Care
timeFrame: 5.5years
measure: Staff satisfaction
timeFrame: 5.5years
measure: Kangarooing time
timeFrame: 5.5yrs
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Mihatsch Walter
state: Baden Wuerttemberg
city: Giessen
country: Germany
facility: Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
state: Hesse
Study officials:
affiliation: Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany
name: Rahel Schuler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuler R, Ehrhardt H, Mihatsch WA. Safety and Parental Satisfaction With Early Discharge of Preterm Infants on Nasogastric Tube Feeding and Outpatient Clinic Follow-Up. Front Pediatr. 2020 Aug 25;8:505. doi: 10.3389/fped.2020.00505. eCollection 2020.