PretermRISEinFAMILYNCT06087666
Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units
A study testing FICare in people with Preterm, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in 2 countries.
Trial summary
International, multi-centre, pluri-cultural, stepped wedge cluster controlled trial, to demonstrate superiority of site tailored 'Family integrated care model'(FICare), that promotes the active participation of the parents as primary caregivers of their infants in neonatal intensive care units (NICU), versus standard… Read more about this study
- Who is it for?
- Ages 0 weeks to 1 year
- Conditions the study is for
- Preterm
- What is being tested?
- FICare
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 weeks to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight at or below 1500 g or gestational age at or below 34 weeks.
- Any other peri-neonatal condition anticipating NICU specialised care.
- Admission for at least 7 days
- Decision to provide full life support.
- Willingness to spend at least 6h per day at NICU OR commitment to attend educational sessions
- Active involvement in care for their infant at least a 7 day-period
Show all 9Show fewer
- No intellectual or language barriers[A] to understanding
- At least one primary caregivers involved in training [B]
- Signed informed consent
Who cannot join
- Decision not to provide full life support
- Critical illness unlikely to survive
- Scheduled for early transfer to another non-FICare hospital (expected hospital stay <7days)
- Intellectual handicaps that makes difficult learning-understanding
- Communication cannot be established even with translator
- Mental, psychiatric problems or under legal supervision
- Newborn under guardianship of social services
- Lack of parental signed informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, 06560
Nuriye Ebru Ergenekon, Prof. Dr, +90 312 202 6032, ebruer@gazi.edu.tr
About this study
Official title: Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres: the Impact of the Program
International, multi-centre, pluri-cultural, stepped wedge cluster controlled trial, to demonstrate superiority of site tailored 'Family integrated care model'(FICare), that promotes the active participation of the parents as primary caregivers of their infants in neonatal intensive care units (NICU), versus standard NICU care delivery with regards to short-term health outcomes in high-risk newborns with prolonged hospital stay.
- Conditions
- Preterm
- Being tested
- FICare
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FICareProcedure or surgery
The Family Integrated Care (FICare) programme has been developed in a multicenter cluster randomised controlled trial, with 26 tertiary NICUs from Canada, Australia and New Zealand, comparing standard NICU care (which was mainly care by nurses) (891 infants) to FICare programme (895 infants). FICare model and showed that the involvement of parents in the direct care improved weight gain and increased breastfeeding rates in the preterm infants. In addition, their parents had lower rates of stress and anxiety. These results were confirmed in a cluster-randomised controlled trial. Subsequent studies carried out so far have shown promising positive effects on a variety of domains. Maturation profiles have been shown to accelerate with the FICare intervention as a shorter time to achieve exclusive enteral nutrition as well as oral nutrition has been shown in the preterm infants included in FICARE programmes compared to control babies
| Study group | Role | What they receive |
|---|---|---|
| FICare intervention | Experimental | FICare implementation model will be demonstrated by setting 5 pilots in non-FICare-experienced NICUs from NL, TR, RO, UK, ZM (AMC, GU, CLUJ, UHS, and UNZA, partners, respectively) and 2 pilots in clinical sites who have recently implemented FICare from ES and NL (SERMAS and OLVG). Receives: Procedure: FICare |
| control intervention | No intervention | A cohort of patients born at the non-FICare clinical sites (AMC, GU, CLUJ, UHS, and UNZA) from the start of the study (November 2022) to the time assigned to start the intervention. A 3-month washout period will be established for staff training and site readiness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RISEinFAMILY implementation:
proportion of families completing basic and advanced training levels (observed vs expected).
Measured: Through study completion (average of 24 months)
RISEinFAMILY implementation:
Average time to complete basic and advanced training levels (observed vs expected)
Measured: Through study completion (average of 24 months)
RISEinFAMILY implementation:
Average time of kangaroo care per day
Measured: Through study completion (average of 24 months)
Short-term health infant's outcomes
proportion of high-risk infants achieving and maintaining adequate growth patterns during NICU admission.
Measured: Through study completion (average of 24 months)
Secondary outcomes (22)
Reported adverse event rate per 1000 patients/day
Measured: Through study completion (average of 24 months)
Feeding patterns at discharge:
proportion of infants on exclusive breastfeeding
Measured: Through study completion (average of 24 months)
Brestfeeding rates at discharge:
Number of patients with no breastfeeding
Measured: Through study completion (average of 24 months)
Brestfeeding rates at discharge:
Number of patients with <50% of intake
Measured: Through study completion (average of 24 months)
Brestfeeding rates at discharge:
Number of patients with >50% of intake
Measured: Through study completion (average of 24 months)
Parental psychological health
Parental stress will be measured using the abbreviated Pediatric Stress Scale for Pediatric Intensive Care Unit (PSS PICU).
Scale ranges from 0 to 5, higher scores indicate worse outcomes
Measured: Through study completion (average of 24 months)
Parental psychological health
Anxiety and depression symptoms will be measured using the Four Item Patient health (PHQ-4).
Scale ranges from 0 to 3, higher scores indicate worse outcomes
Measured: Through study completion (average of 24 months)
Parental psychological health
Postnatal depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS).
Scale ranges from 0 to 3, higher scores indicate worse outcome.
Measured: Through study completion (average of 24 months)
Parental psychological health
Maternal self-efficacy will be measured using the Perceived Maternal Parenting Self-Efficacy (PMP S-E).
Scale ranges from 0 to 3, higher scores indicate better outcome
Measured: Through study completion (average of 24 months)
Parental psychological health
Maternal-to-infant-bonding scale will be measured using the Maternal-to-Infant Bonding Scale.
Score ranges 0 to 3. For items 1,2 and 6, higher scores correlate to better outcomes; for items 2, 3, 5, 7 and 8, higher scores correlate to a worse outcome.
Measured: Through study completion (average of 24 months)
Parental psychological health
Resilience will be measured Brief Resilience Scale. Scale ranges from 0 yo 6. For items 4, 7, 9, 12, 17, 18, 19 and 21, higher scores indicate a better outcome. For items 1, 2, 3, 5, 6, 8, 10, 11, 13, 14, 15, 16m 20 and 22 a higher score indicates a worse outcome.
Measured: Through study completion (average of 24 months)
Feeding patterns at discharge:
Day of life (DOL) to complete oral feeding (nasogastric tube removed)
Measured: Through study completion (average of 24 months)
Feeding patterns at discharge:
day of life (DOL) to reach full enteral nutrition (>130 mL/K/day)
Measured: Through study completion (average of 24 months)
Feeding patterns at discharge:
DOL at discharge
Measured: Through study completion (average of 24 months)
Proportion of infants diagnosed of (at 36 weeks PMA or discharge): bronchopulmonary dysplasia, oxygen dependency, severe retinopathy of prematurity (grade 3 or need for treatment), nosocomial infection necrotising enterocoli
Measured: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
Anxiety and depression symptoms will be measured using the anxiety and depression survey (PHQ-4).
The scale ranges from 1 to 3. Higher scores indicate a worse outcome.
Measured: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
burnout symptoms will be measured using the Maslach burnout inventory human services survey (MBI-HSS). Scale ranges from 0 to 6. For Items 4, 7, 9, 12, 17, 18, 19 and 21, higher scores indicate a better outcome. For items 1, 2, 3, 5, 6, 8, 10, 11, 13, 14, 15, 16, 20 and 22, higher scores indicate a worse outcome.
Measured: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
post-traumatic stress will be measured using (post traumatic stress survey (PTSD-8). Scale ranges from 0 to 3, higher scores indicate worse outcomes
Measured: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
Work and wellbeing will be measured using Unwes-9 work and well-being survey (UWES).
Scale ranges from 0 to 6, a higher score indicates a better outcome
Measured: Through study completion (average of 24 months)
Feeding patterns at discharge:
postmenstrual age (PMA) to complete oral feeding (nasogastric tube removed)
Measured: Through study completion (average of 24 months)
Feeding patterns at discharge:
postmenstrual age (PMA) to reach full enteral nutrition (>130 mL/K/day)
Measured: Through study completion (average of 24 months)
Feeding patterns at discharge:
postmenstrual age (PMA) at discharge
Measured: Through study completion (average of 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PretermStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- stepped wedge cluster controlled trial
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adelina Pellicer, MD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087666
- Sponsor's protocol ID
- 101007922
- Acronym
- RISEinFAMILY
- Status last verified
- Oct 2023
- First submitted
- 26 May 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alferink MT, Moreno-Sanz B, Cabrera-Lafuente M, Ergenekon E, de Haan TR, van Kempen AAMW, Lakhwani J, Rabe H, Zaharie GC, Pellicer A; RISEinFAMILY Consortium (European Union, MSCA-RISE-H2020). RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial. Trials. 2024 Apr 10;25(1):248. doi: 10.1186/s13063-024-08043-7.
PubMed 38594733
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres: the Impact of the Program
- ClinicalTrials.gov ID
- NCT06087666
- Acronym / sponsor ID
- RISEinFAMILY / 101007922
- Conditions
- Preterm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Oct 2023 (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.
International, multi-centre, pluri-cultural, stepped wedge cluster controlled trial, to demonstrate superiority of site tailored 'Family integrated care model'(FICare), that promotes the active participation of the parents as primary caregivers of their infants in neonatal intensive care units (NICU), versus standard NICU care delivery with regards to short-term health outcomes in high-risk newborns with prolonged hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- stepped wedge cluster controlled trial
| Arm | Type | Receives |
|---|---|---|
| FICare intervention | Experimental | Procedure: FICareFICare implementation model will be demonstrated by setting 5 pilots in non-FICare-experienced NICUs from NL, TR, RO, UK, ZM (AMC, GU, CLUJ, UHS, and UNZA, partners, respectively) and 2 pilots in clinical sites who have recently implemented FICare from ES and NL (SERMAS and OLVG). |
| control intervention | No intervention | –A cohort of patients born at the non-FICare clinical sites (AMC, GU, CLUJ, UHS, and UNZA) from the start of the study (November 2022) to the time assigned to start the intervention. A 3-month washout period will be established for staff training and site readiness. |
Who may qualify
- Ages
- 0 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Birth weight at or below 1500 g or gestational age at or below 34 weeks.
- Any other peri-neonatal condition anticipating NICU specialised care.
- Admission for at least 7 days
- Decision to provide full life support.
- Willingness to spend at least 6h per day at NICU OR commitment to attend educational sessions
Key exclusion criteria (8 listed)
- Decision not to provide full life support
- Critical illness unlikely to survive
- Scheduled for early transfer to another non-FICare hospital (expected hospital stay <7days)
- Intellectual handicaps that makes difficult learning-understanding
- Communication cannot be established even with translator
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 |
|---|---|---|
| FICareThe Family Integrated Care (FICare) programme has been developed in a multicenter cluster randomised controlled trial, with 26 tertiary NICUs from Canada, Australia and New Zealand, comparing standard NICU care (which was mainly care by nurses) (891 infants) to FICare programme (895 infants). FICare model and showed that the involvement of parents in the direct care improved weight gain and increased breastfeeding rates in the preterm infants. In addition, their parents had lower rates of stress and anxiety. These results were confirmed in a cluster-randomised controlled trial. Subsequent studies carried out so far have shown promising positive effects on a variety of domains. Maturation profiles have been shown to accelerate with the FICare intervention as a shorter time to achieve exclusive enteral nutrition as well as oral nutrition has been shown in the preterm infants included in FICARE programmes compared to control babies | Procedure or surgery | FICare intervention |
Primary outcome
RISEinFAMILY implementation:
Time frame: Through study completion (average of 24 months)
proportion of families completing basic and advanced training levels (observed vs expected).
RISEinFAMILY implementation:
Time frame: Through study completion (average of 24 months)
Average time to complete basic and advanced training levels (observed vs expected)
RISEinFAMILY implementation:
Time frame: Through study completion (average of 24 months)
Average time of kangaroo care per day
Short-term health infant's outcomes
Time frame: Through study completion (average of 24 months)
proportion of high-risk infants achieving and maintaining adequate growth patterns during NICU admission.
22 secondary outcomes
Reported adverse event rate per 1000 patients/day
Time frame: Through study completion (average of 24 months)
Feeding patterns at discharge:
Time frame: Through study completion (average of 24 months)
Brestfeeding rates at discharge:
Time frame: Through study completion (average of 24 months)
Brestfeeding rates at discharge:
Time frame: Through study completion (average of 24 months)
Brestfeeding rates at discharge:
Time frame: Through study completion (average of 24 months)
Parental psychological health
Time frame: Through study completion (average of 24 months)
Parental psychological health
Time frame: Through study completion (average of 24 months)
Parental psychological health
Time frame: Through study completion (average of 24 months)
Parental psychological health
Time frame: Through study completion (average of 24 months)
Parental psychological health
Time frame: Through study completion (average of 24 months)
Parental psychological health
Time frame: Through study completion (average of 24 months)
Feeding patterns at discharge:
Time frame: Through study completion (average of 24 months)
Feeding patterns at discharge:
Time frame: Through study completion (average of 24 months)
Feeding patterns at discharge:
Time frame: Through study completion (average of 24 months)
Proportion of infants diagnosed of (at 36 weeks PMA or discharge): bronchopulmonary dysplasia, oxygen dependency, severe retinopathy of prematurity (grade 3 or need for treatment), nosocomial infection necrotising enterocoli
Time frame: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
Time frame: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
Time frame: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
Time frame: Through study completion (average of 24 months)
Satisfaction and self-care of professionals measured by surveys
Time frame: Through study completion (average of 24 months)
Feeding patterns at discharge:
Time frame: Through study completion (average of 24 months)
Feeding patterns at discharge:
Time frame: Through study completion (average of 24 months)
Feeding patterns at discharge:
Time frame: Through study completion (average of 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 38594733Alferink MT, Moreno-Sanz B, Cabrera-Lafuente M, Ergenekon E, de Haan TR, van Kempen AAMW, Lakhwani J, Rabe H, Zaharie GC, Pellicer A; RISEinFAMILY Consortium (European Union, MSCA-RISE-H2020). RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial. Trials. 2024 Apr 10;25(1):248. doi: 10.1186/s13063-024-08043-7.
- Individual participant dataSharing planned: Undecided
Related trials for Preterm
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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. This study is not recruiting at the moment.
Adelina Pellicer, MD principal investigator
Hospital Universitario La Paz
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FICare in people with Preterm, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in 2 countries.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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 Spain, Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adelina Pellicer, MD (617316799, adelina.pellicer@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RISEinFAMILY implementation: (time frame: Through study completion (average of 24 months)). The study lists 4 primary outcomes in all. 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 NCT06087666, which also lists 1 linked publication.
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 18 Oct 2023.