Family Centered CareNCT05286983
Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project
An observational study of Family Centered Care, run by University of Giessen at 2 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 1 minute to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Family Centered Care
- What is being tested?
- Family Centred Care (FCC) interventions as potentially better practices (PBPs)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 495 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2020to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 14 days
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
- biparental (or guardian) written informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Harald Ehrhardt, Prof. contact
Germany2 sites, 1 recruiting
- Recruiting
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
Giessen, Hesse, 35390
Rahel Schuler, +4964198558821, rahel.schuler@paediat.med.uni-giessen.de
Harald Ehrhardt, harald.ehrhardt@paediat.med.uni-giessen.de
- Active, not recruiting
Mihatsch Walter
Ulm, Baden-Wurttemberg, 89231
About this study
Official title: 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.
Read the 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.
- Conditions
- Family Centered Care
- Being tested
- Family Centred Care (FCC) interventions as potentially better practices (PBPs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Centred Care (FCC) interventions as potentially better practices (PBPs)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) | |
| 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. Receives: Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay measured by corrected gestational age at discharge
Measured: 5.5years
Secondary outcomes (29)
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
Measured: 5.5years
Weight gain
weight gain (g/kg/d) from admission to 36+0/40+0 weeks (corrected age)
Measured: 5.5years
Weight Z-Score
Z- Scores for weight at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Measured: 5.5years
Weight
Weight in Gram at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Measured: 5.5years
Length Z-Score
Z- Scores for length at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Measured: 5.5years
Length
Length in cm at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Measured: 5.5years
Head Circumference Z-Score
Z- Scores for head circumference at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Measured: 5.5years
Head Circumference
Head circumference in cm at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Measured: 5.5years
Full enteral feeds
Day of Life (DOL) of achievement of full enteral feeds defined as 150ml/kg/d for 3 consecutive days
Measured: 5.5 years
Length of tube feeding
corrected gestational age at removal of nasogastric tube
Measured: 5.5 years
First Breastmilk Feed
DOL (Day of Life) with first breast milk feed
Measured: 5.5years
Breastmilk Nutrition
Breastmilk proportion within Day of Life (DOL) 1-14
Measured: 5.5years
Fully Breastfed
DOL when infant is fed only with breast milk
Measured: 5.5years
Breastfeeding at Discharge
Breast milk proportion at discharge
Measured: 5.5years
Mechanical ventilation
Gestational age (GA) at end of respiratory support: Continuous Positive Airway Pressure (CPAP)/ Highflow Nasal Cannula (HFNC)/ oxygen supplementation
Measured: 5.5years
End of parenteral nutrition (PN)
DOL of end of PN
Measured: 5.5years
Family room
cGA at move-in with mother or father into a family room
Measured: 5.5years
Neurodevelopment at 12 months corrected age
Neurodevelopment measured with Neuropsychological Developmental Screening, Score 0-15, higher scores indicating better neurodevelopment
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5.5years
Parental Satisfaction
Measured with a newly designed Questionnaire focussing on Neonatal Intensive Care Surroundings, Visiting Hours, Medical Care and communication
Measured: 5.5years
Parental Skills
Self assessed with a Questionnaire
Measured: 5.5years
Parental Visiting Hours
Time spent with the infant. Measured seperately for mothers and fathers throughout hospital stay
Measured: 5.5years
Degree of Family Centred Care
Self Assessment Questionnaire (Institute for Family Centred Care) by staff members
Measured: 5.5years
Staff satisfaction
Self assessment (Copenhagen Psychosocial Questionnaire, COPSQ) by staff members
Measured: 5.5years
Kangarooing time
Time spent kangarooing with the infant. Measured separately for mothers and fathers throughout the NICU stay
Measured: 5.5yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Oct 2020
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family Centered CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm
- Responsible party
- Principal investigator, Dr. Rahel Schuler, University of Giessen
- Investigators
- Rahel Schuler, Principal investigator, Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286983
- Sponsor's protocol ID
- 153/20
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32984217Schuler R, Woitschitzky L, Eiben C, Beck J, Jagers A, Windhorst A, Kampschulte B, Petzinger J, Waitz M, Kilsdonk MOR, Neubauer BA, Zimmer KP, Ehrhardt H, Brosig B, Mihatsch WA. Multidimensional assessment of infant, parent and staff outcomes during a family centered care enhancement project in a tertiary neonatal intensive care unit: study protocol of a longitudinal cohort study. BMC Pediatr. 2023 Jul 7;23(1):344. doi: 10.1186/s12887-023-04165-0.
PubMed 37420180
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT05286983
- Acronym / sponsor ID
- 153/20
- Conditions
- Family Centered Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- University of Ulm
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K2 - 2nd intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K3 - 3rd intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K4 - 4th intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K5 - 5th intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K6 - 6th intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K7 - 7th intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K8 - 8th intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K9 - 9th intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
| K10 - 10th intervention cohort | – | Behavioral: Family Centred Care (FCC) interventions as potentially better practices (PBPs)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. |
Who may qualify
- Ages
- 1 minute to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
- biparental (or guardian) written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | K1 - 1st intervention cohort, K10 - 10th intervention cohort, K2 - 2nd intervention cohort, K3 - 3rd intervention cohort, K4 - 4th intervention cohort, K5 - 5th intervention cohort, K6 - 6th intervention cohort, K7 - 7th intervention cohort, K8 - 8th intervention cohort, K9 - 9th intervention cohort |
Primary outcome
Length of hospital stay
Time frame: 5.5years
Length of hospital stay measured by corrected gestational age at discharge
29 secondary outcomes
Key neonatal morbidities
Time frame: 5.5years
Weight gain
Time frame: 5.5years
Weight Z-Score
Time frame: 5.5years
Weight
Time frame: 5.5years
Length Z-Score
Time frame: 5.5years
Length
Time frame: 5.5years
Head Circumference Z-Score
Time frame: 5.5years
Head Circumference
Time frame: 5.5years
Full enteral feeds
Time frame: 5.5 years
Length of tube feeding
Time frame: 5.5 years
First Breastmilk Feed
Time frame: 5.5years
Breastmilk Nutrition
Time frame: 5.5years
Fully Breastfed
Time frame: 5.5years
Breastfeeding at Discharge
Time frame: 5.5years
Mechanical ventilation
Time frame: 5.5years
End of parenteral nutrition (PN)
Time frame: 5.5years
Family room
Time frame: 5.5years
Neurodevelopment at 12 months corrected age
Time frame: 7.5years
Neurodevelopmental outcome at 24 months corrected age
Time frame: 7.5years
Motor Developmental outcome at 24 months corrected age
Time frame: 7.5years
Parental Anxiety
Time frame: 5.5years
Parental Depression
Time frame: 5.5years
Parental Stress
Time frame: 5.5years
Parental Satisfaction
Time frame: 5.5years
Parental Skills
Time frame: 5.5years
Parental Visiting Hours
Time frame: 5.5years
Degree of Family Centred Care
Time frame: 5.5years
Staff satisfaction
Time frame: 5.5years
Kangarooing time
Time frame: 5.5yrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 32984217Schuler 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.
- Derived from this study: PubMed 37420180Schuler R, Woitschitzky L, Eiben C, Beck J, Jagers A, Windhorst A, Kampschulte B, Petzinger J, Waitz M, Kilsdonk MOR, Neubauer BA, Zimmer KP, Ehrhardt H, Brosig B, Mihatsch WA. Multidimensional assessment of infant, parent and staff outcomes during a family centered care enhancement project in a tertiary neonatal intensive care unit: study protocol of a longitudinal cohort study. BMC Pediatr. 2023 Jul 7;23(1):344. doi: 10.1186/s12887-023-04165-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harald Ehrhardt, Prof. contact
Rahel Schuler principal investigator
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Centered Care, run by University of Giessen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahel Schuler, Dr. (+4964198558821, rahel.schuler@paediat.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 5.5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286983, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.