Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project

Family Centered Care Clinical Trial

Official title:

Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286983
• Other study ID #: 153/20
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: July 1, 2026

Study information

• Verified date: December 2023
• Source: University of Giessen
• Contact: Rahel Schuler, Dr.
• Phone: +4964198558821
• Email: rahel.schuler[@]paediat.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 495
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Minute to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Family Centered Care

Intervention

Behavioral:
• Family Centred Care (FCC) interventions as potentially better practices (PBPs)
After the previous period, additional Family Centred Care (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. The focus group consisting of nurses and healthcare professionals will meet regularly and will decide on new FCC interventions as potentially better practices (PBPs). New additional PBPs will be disseminated into the greater team through workshops, hands-on teaching, displays, etc. Potential PBPs for our department enclose: Parent participation on rounds Parent skill self-assessment Parent-to-parent support Regular staff education Improvement of psychosocial support Improvement of neonatal unit surroundings to promote parent-infant-closeness

Locations

Country	Name	City	State
Germany	Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany	Giessen	Hesse
Germany	Mihatsch Walter	Ulm	Baden Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Length of hospital stay measured by corrected gestational age at discharge	5.5years
Secondary	Key neonatal morbidities	Number of Participants with Bronchopulmonary Dysplasia (BPD), Number of Participants with Intraventricular Hemorrhage (IVH) Grade III-IV, Number of Participants with Periventricular Leucomalacia (PVL), Number of Participants with Necrotizing Enterocolitis (NEC) stage 2 or stage 3, Number of Participants with Retinopathia of Prematurity (ROP) stage 3 or greater or treatment	5.5years
Secondary	Weight gain	weight gain (g/kg/d) from admission to 36+0/40+0 weeks (corrected age)	5.5years
Secondary	Weight Z-Score	Z- Scores for weight at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Secondary	Weight	Weight in Gram at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Secondary	Length Z-Score	Z- Scores for length at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Secondary	Length	Length in cm at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Secondary	Head Circumference Z-Score	Z- Scores for head circumference at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Secondary	Head Circumference	Head circumference in cm at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Secondary	Full enteral feeds	Day of Life (DOL) of achievement of full enteral feeds defined as 150ml/kg/d for 3 consecutive days	5.5 years
Secondary	Length of tube feeding	corrected gestational age at removal of nasogastric tube	5.5 years
Secondary	First Breastmilk Feed	DOL (Day of Life) with first breast milk feed	5.5years
Secondary	Breastmilk Nutrition	Breastmilk proportion within Day of Life (DOL) 1-14	5.5years
Secondary	Fully Breastfed	DOL when infant is fed only with breast milk	5.5years
Secondary	Breastfeeding at Discharge	Breast milk proportion at discharge	5.5years
Secondary	Mechanical ventilation	Gestational age (GA) at end of respiratory support: Continuous Positive Airway Pressure (CPAP)/ Highflow Nasal Cannula (HFNC)/ oxygen supplementation	5.5years
Secondary	End of parenteral nutrition (PN)	DOL of end of PN	5.5years
Secondary	Family room	cGA at move-in with mother or father into a family room	5.5years
Secondary	Neurodevelopment at 12 months corrected age	Neurodevelopment measured with Neuropsychological Developmental Screening, Score 0-15, higher scores indicating better neurodevelopment	7.5years
Secondary	Neurodevelopmental outcome at 24 months corrected age	Neurodevelopmental outcome measured with Bayley Scales of Infant Development, German Version, 3rd Edition (mean 100; Standard Deviation 15, higher Scores indicating better neurodevelopment)	7.5years
Secondary	Motor Developmental outcome at 24 months corrected age	Gross Motor Function Classification System (GMFCS), Grade I-V, higher Grade indicating worse motor outcome	7.5years
Secondary	Parental Anxiety	Parental Anxiety, measured with the German version of the Hospital and Anxiety and Depression Scale (HADS-D) within the first 10 days after birth, after 4 weeks, at discharge, at 3, 12 and 24 months (corrected age of the preterm infant), Score 0-21; higher scores indicating more anxiety	5.5years
Secondary	Parental Depression	Parental Depression measured with the German version of the Hospital and Anxiety and Depression Scale (HADS-D) within the first 10 days after birth, after 4 weeks, at discharge, at 3, 12 and 24 months (corrected age of the preterm infant), Score 0-21, higher scores indicating more depression	5.5years
Secondary	Parental Stress	Parental Stress measured with the Parenting Stress Index (PSI), German Version (Eltern-Belastungs-Inventar, EBI) within the first 10 days after birth, after 4 weeks, at discharge, at 3, 12 and 24 months (corrected age of the preterm infant); Score 0-100, higher score indicating more stress	5.5years
Secondary	Parental Satisfaction	Measured with a newly designed Questionnaire focussing on Neonatal Intensive Care Surroundings, Visiting Hours, Medical Care and communication	5.5years
Secondary	Parental Skills	Self assessed with a Questionnaire	5.5years
Secondary	Parental Visiting Hours	Time spent with the infant. Measured seperately for mothers and fathers throughout hospital stay	5.5years
Secondary	Degree of Family Centred Care	Self Assessment Questionnaire (Institute for Family Centred Care) by staff members	5.5years
Secondary	Staff satisfaction	Self assessment (Copenhagen Psychosocial Questionnaire, COPSQ) by staff members	5.5years
Secondary	Kangarooing time	Time spent kangarooing with the infant. Measured separately for mothers and fathers throughout the NICU stay	5.5yrs