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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Family Centered Care
• Intervention / Treatment: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)

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.

• Study Type: Observational
• Enrollment (Estimated): 495

Contacts and Locations

• Study Contact: Name: Rahel Schuler, Dr.; Phone Number: +4964198558821; Email: rahel.schuler@paediat.med.uni-giessen.de
• Study Contact Backup: Name: Harald Ehrhardt, Prof.; Email: harald.ehrhardt@paediat.med.uni-giessen.de

Study Locations

• Germany
  • Baden Wuerttemberg
    • Ulm, Baden Wuerttemberg, Germany, 89231
      • Active, not recruiting
      • Mihatsch Walter
  • Hesse
    • Giessen, Hesse, Germany, 35390
      • Recruiting
      • Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
      • Contact: Rahel Schuler; Phone Number: +4964198558821; Email: rahel.schuler@paediat.med.uni-giessen.de
      • Contact: Harald Ehrhardt; Email: harald.ehrhardt@paediat.med.uni-giessen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

11

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
K0 - baseline cohort; 45 preterm infants and their parents (average number of patient admissions per 6 months during the last 5 years)
K1 - 1st intervention cohort; All preterm infants and their parents enrolled during the first 6 months period after completion of the baseline cohort and who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K2 - 2nd intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K3 - 3rd intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K4 - 4th intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K5 - 5th intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K6 - 6th intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K7 - 7th intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K8 - 8th intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K9 - 9th intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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
K10 - 10th intervention cohort; All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay measured by corrected gestational age at discharge	5.5years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Weight gain	weight gain (g/kg/d) from admission to 36+0/40+0 weeks (corrected age)	5.5years
Weight Z-Score	Z- Scores for weight at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Weight	Weight in Gram at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Length Z-Score	Z- Scores for length at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Length	Length in cm at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Head Circumference Z-Score	Z- Scores for head circumference at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
Head Circumference	Head circumference in cm at 36+0, 40+0, 3, 12 and 24 months (corrected age)	5.5years
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
Length of tube feeding	corrected gestational age at removal of nasogastric tube	5.5 years
First Breastmilk Feed	DOL (Day of Life) with first breast milk feed	5.5years
Breastmilk Nutrition	Breastmilk proportion within Day of Life (DOL) 1-14	5.5years
Fully Breastfed	DOL when infant is fed only with breast milk	5.5years
Breastfeeding at Discharge	Breast milk proportion at discharge	5.5years
Mechanical ventilation	Gestational age (GA) at end of respiratory support: Continuous Positive Airway Pressure (CPAP)/ Highflow Nasal Cannula (HFNC)/ oxygen supplementation	5.5years
End of parenteral nutrition (PN)	DOL of end of PN	5.5years
Family room	cGA at move-in with mother or father into a family room	5.5years
Neurodevelopment at 12 months corrected age	Neurodevelopment measured with Neuropsychological Developmental Screening, Score 0-15, higher scores indicating better neurodevelopment	7.5years
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
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
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
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
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
Parental Satisfaction	Measured with a newly designed Questionnaire focussing on Neonatal Intensive Care Surroundings, Visiting Hours, Medical Care and communication	5.5years
Parental Skills	Self assessed with a Questionnaire	5.5years
Parental Visiting Hours	Time spent with the infant. Measured seperately for mothers and fathers throughout hospital stay	5.5years
Degree of Family Centred Care	Self Assessment Questionnaire (Institute for Family Centred Care) by staff members	5.5years
Staff satisfaction	Self assessment (Copenhagen Psychosocial Questionnaire, COPSQ) by staff members	5.5years
Kangarooing time	Time spent kangarooing with the infant. Measured separately for mothers and fathers throughout the NICU stay	5.5yrs

Collaborators and Investigators

• Sponsor: University of Giessen
• Collaborators: University of Ulm
• Investigators: Principal Investigator: Rahel Schuler, Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 153/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No