Premature Birth of NewbornmFI-CareNCT03418870
Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology
A study testing Family Integrated Care in people with Premature Birth of Newborn, run by University of California, San Francisco at 6 sites in United States.
Trial summary
The purpose of this study is to compare the standard of care in the neonatal intensive care unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced Family Integrated Care. Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- Premature Birth of Newborn
- What is being tested?
- Family Integrated Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Apr 2017to 15 Mar 2021
- 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 Up to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant ≤ 33 weeks and their parent or guardian
Who cannot join
- Infant has a life-threatening congenital anomaly, is unlikely to survive or is receiving palliative care
- Parent is not English literate
- Parent < 18 years of age
- Parent does not have access to hand-held computer (smartphone or tablet)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Community Regional Medical Center
Fresno, California, 93721
Jacobs Medical Center, UC San Diego Health
La Jolla, California, 92037
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
UCSF Benioff Children's Hospital San Francisco
San Francisco, California, 94158
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
About this study
The purpose of this study is to compare the standard of care in the neonatal intensive care unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced Family Integrated Care. This exploratory two-group comparison study will examine the feasibility, acceptability and effectiveness, providing the first United States (US) information about outcomes of a new NICU care model that better integrates parents into all aspects of their baby's care. The use of mobile technology as part of this new model of care could improve access and equity in family integration for the many US families who face barriers to NICU involvement.
Read the detailed description
Poor growth during neonatal intensive care unit (NICU) hospitalization is a modifiable risk factor contributing to mortality and serious long-term morbidity for many of the nearly 400,000 preterm infants born each year in the United States (US). Active parent involvement in preterm infant caregiving promotes parent-infant attachment and leads to higher breastfeeding rates, earlier discharge, and improved long-term neurodevelopment. Despite decades of evidence of the positive effects of parental involvement, parents remain for the most part passive bystanders in the NICU setting. Even with many NICUs adopting a Family-Centered Care (FCC) approach, parent-infant contact and parenting skills remain well below desired levels.
Family Integrated Care (FI-Care) is a novel intervention that differs from FCC because it formally teaches and supports parents to be primary caregivers for their infants and restructures the relationship between parents and clinicians so that parents are fully integrated into the care team. There is strong evidence from a large, well-designed cluster randomized trial conducted in Canada and Australia that FI-Care improves infant growth and breastfeeding rates and reduces maternal stress. However, these findings cannot be generalized to US NICUs where parents face many barriers to involvement in their infant's NICU care. The research team has developed a secure, HIPAA-compliant, mobile application to capture high quality data about parent involvement in NICU caregiving and to deliver essential elements of the FI-Care program remotely. This mobile-enhanced FI-Care (mFI-Care) may improve involvement of parents who cannot be present in the NICU during daytime hours due to distance, employment or other responsibilities and family commitments. Increasing access and equity in family-integrated care may improve outcomes for US preterm infants.
This exploratory two-group, multi-site comparison study will compare usual FCC with mFI-Care on growth and clinical outcomes of preterm infants < 33 weeks gestational age, as well as the stress, competence and self-efficacy of their parents. The feasibility and acceptability of using mobile technology to gather data about parent involvement in the care of preterm infants receiving FCC or mFICare as well as of the mFI-Care intervention will be evaluated (Aim 1). The effect sizes for infant growth (primary outcome) and for secondary infant and parent outcomes at NICU discharge and three months after discharge will be estimated (Aim 2). This study will provide important new information on innovative approaches to increasing parent involvement in NICU infant caregiving, including the use of a novel mobile application. The findings will be used to develop a future US cluster-randomized trial of mFI-Care with the aim of improving outcomes for preterm infants and their parents.
- Conditions
- Premature Birth of Newborn
- Being tested
- Family Integrated Care
- Keywords
- Intensive Care Units, Neonatal, Parents, Mobile application
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Integrated CareBehavioural
Parents of infants assigned to mFI-Care will be trained and treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches.
| Study group | Role | What they receive |
|---|---|---|
| Family Integrated Care (mFI-Care) | Experimental | Parents of infants assigned to the Family Integrated Care (mFI-Care) intervention will be treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches. Parent training on the Canadian FI-Care Parent Curriculum will be provided during small group sessions facilitated by the study team. Parents will receive peer support from mFI-Care-trained alumni parents and can interact with other mFI-Care parents through the We3Health App secure online parent forum. mFI-Care parents will be expected to track time spent with their infant; record infant activity, feeds and output; track learning and skills acquisition; and keep a journal of the NICU experience using the We3Health app. Receives: Behavioral: Family Integrated Care |
| Family-Centered Care (FCC) | No intervention | Infants assigned to usual FCC will have NICU nurses as primary caregivers per standard NICU protocol. FCC provides parents with orientation to the NICU; individualized teaching and support; and encouragement to participate in infant care under nursing supervision. Individualized support from social workers, lactation consultants and other specialists will be offered. As part of the study, parents will be asked to use the We3Health mobile app track their time in the NICU, time learning and time spent in infant caregiving activities and to keep of a journal of their NICU experience. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infant weight (z-score)
Z-score will be calculated by obtaining weight in kilograms from medical record and compared between the mFICare and usual FCC groups
Measured: 21 days of age after enrollment
Secondary outcomes (9)
Amount of human milk/formula supplementation
number of ml for all breast feeding, breast pumping, bottle feeding, and nasal gastric (NG) feeding will be obtained from the medical record
Measured: At study enrollment and at hospital discharge, usually 21 days after admission
Frequency of breastfeeding
Number of feedings for breast feeding, breast pumping, bottle feeding, and NG feeding will be obtained from the medical record
Measured: At study enrollment and at hospital discharge, usually 21 days after admission
Breastfeeding rate
Breastfeeding rate will be calculated using amount of Number of feedings and ml for breast feeding, breast pumping, bottle feeding, and NG feeding will be obtained from the medical record
Measured: At study enrollment and at hospital discharge, usually 21 days after admission
Length of stay
Number of days of NICU and hospital stay
Measured: Number of days of NICU and hospital stay, usually 21 days after admission
Weight gain velocity
number of grams gained from enrollment to specified date divided by the number of days = weight gain velocity
Measured: at NICU discharge, usually 21 days after admission
Major morbidities
Nosocomial infection, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, and adverse events.
Measured: at NICU discharge, usually 21 days after admission
Parent perceived stress
Self- reported survey
Measured: at NICU discharge, usually 21 days after admission
Parenting competence
self reported survey
Measured: at NICU discharge, usually 21 days after admission
Perceived parenting self-efficacy
self-reported survey
Measured: at NICU discharge, usually 21 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start3 Apr 2017
- Primary completion31 Jan 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 is "usual care" and Phase 2 is the intervention phase.
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, San Diego, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Linda Franck, RN, PhD, Principal investigator, Dept of Family Care Nursing, California Preterm Birth Initiative, UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418870
- Sponsor's protocol ID
- 16-19542
- Acronym
- mFI-Care
- Status last verified
- Mar 2021
- First submitted
- 18 Dec 2017
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.
PubMed 26671340Franck LS, Magana J, Bisgaard R, Lothe B, Sun Y, Morton CH. Mobile-enhanced Family Integrated Care for preterm infants: A qualitative study of parents' views. PEC Innov. 2024 Apr 30;4:100284. doi: 10.1016/j.pecinn.2024.100284. eCollection 2024 Dec.
PubMed 38737891Franck LS, Gay CL, Hoffmann TJ, Kriz RM, Bisgaard R, Cormier DM, Joe P, Lothe B, Sun Y. Neonatal outcomes from a quasi-experimental clinical trial of Family Integrated Care versus Family-Centered Care for preterm infants in U.S. NICUs. BMC Pediatr. 2022 Nov 22;22(1):674. doi: 10.1186/s12887-022-03732-1.
PubMed 36418988Furtak SL, Gay CL, Kriz RM, Bisgaard R, Bolick SC, Lothe B, Cormier DM, Joe P, Sasinski JK, Kim JH, Lin CK, Sun Y, Franck LS. What parents want to know about caring for their preterm infant: A longitudinal descriptive study. Patient Educ Couns. 2021 Nov;104(11):2732-2739. doi: 10.1016/j.pec.2021.04.011. Epub 2021 Apr 17.
PubMed 33966954Franck LS, Kriz RM, Bisgaard R, Cormier DM, Joe P, Miller PS, Kim JH, Lin C, Sun Y. Comparison of family centered care with family integrated care and mobile technology (mFICare) on preterm infant and family outcomes: a multi-site quasi-experimental clinical trial protocol. BMC Pediatr. 2019 Dec 2;19(1):469. doi: 10.1186/s12887-019-1838-3.
PubMed 31791285
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology
- ClinicalTrials.gov ID
- NCT03418870
- Acronym / sponsor ID
- mFI-Care / 16-19542
- Conditions
- Premature Birth of Newborn
- Keywords
- Intensive Care Units, Neonatal, Parents, Mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, San Diego, Kaiser Permanente
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 1 Feb 2018 (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.
The purpose of this study is to compare the standard of care in the neonatal intensive care unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced Family Integrated Care. This exploratory two-group comparison study will examine the feasibility, acceptability and effectiveness, providing the first United States (US) information about outcomes of a new NICU care model that better integrates parents into all aspects of their baby's care. The use of mobile technology as part of this new model of care could improve access and equity in family integration for the many US families who face barriers to NICU involvement.
Detailed description
Poor growth during neonatal intensive care unit (NICU) hospitalization is a modifiable risk factor contributing to mortality and serious long-term morbidity for many of the nearly 400,000 preterm infants born each year in the United States (US). Active parent involvement in preterm infant caregiving promotes parent-infant attachment and leads to higher breastfeeding rates, earlier discharge, and improved long-term neurodevelopment. Despite decades of evidence of the positive effects of parental involvement, parents remain for the most part passive bystanders in the NICU setting. Even with many NICUs adopting a Family-Centered Care (FCC) approach, parent-infant contact and parenting skills remain well below desired levels.
Family Integrated Care (FI-Care) is a novel intervention that differs from FCC because it formally teaches and supports parents to be primary caregivers for their infants and restructures the relationship between parents and clinicians so that parents are fully integrated into the care team. There is strong evidence from a large, well-designed cluster randomized trial conducted in Canada and Australia that FI-Care improves infant growth and breastfeeding rates and reduces maternal stress. However, these findings cannot be generalized to US NICUs where parents face many barriers to involvement in their infant's NICU care. The research team has developed a secure, HIPAA-compliant, mobile application to capture high quality data about parent involvement in NICU caregiving and to deliver essential elements of the FI-Care program remotely. This mobile-enhanced FI-Care (mFI-Care) may improve involvement of parents who cannot be present in the NICU during daytime hours due to distance, employment or other responsibilities and family commitments. Increasing access and equity in family-integrated care may improve outcomes for US preterm infants.
This exploratory two-group, multi-site comparison study will compare usual FCC with mFI-Care on growth and clinical outcomes of preterm infants < 33 weeks gestational age, as well as the stress, competence and self-efficacy of their parents. The feasibility and acceptability of using mobile technology to gather data about parent involvement in the care of preterm infants receiving FCC or mFICare as well as of the mFI-Care intervention will be evaluated (Aim 1). The effect sizes for infant growth (primary outcome) and for secondary infant and parent outcomes at NICU discharge and three months after discharge will be estimated (Aim 2). This study will provide important new information on innovative approaches to increasing parent involvement in NICU infant caregiving, including the use of a novel mobile application. The findings will be used to develop a future US cluster-randomized trial of mFI-Care with the aim of improving outcomes for preterm infants and their parents.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 is "usual care" and Phase 2 is the intervention phase.
| Arm | Type | Receives |
|---|---|---|
| Family Integrated Care (mFI-Care) | Experimental | Behavioral: Family Integrated CareParents of infants assigned to the Family Integrated Care (mFI-Care) intervention will be treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches. Parent training on the Canadian FI-Care Parent Curriculum will be provided during small group sessions facilitated by the study team. Parents will receive peer support from mFI-Care-trained alumni parents and can interact with other mFI-Care parents through the We3Health App secure online parent forum. mFI-Care parents will be expected to track time spent with their infant; record infant activity, feeds and output; track learning and skills acquisition; and keep a journal of the NICU experience using the We3Health app. |
| Family-Centered Care (FCC) | No intervention | –Infants assigned to usual FCC will have NICU nurses as primary caregivers per standard NICU protocol. FCC provides parents with orientation to the NICU; individualized teaching and support; and encouragement to participate in infant care under nursing supervision. Individualized support from social workers, lactation consultants and other specialists will be offered. As part of the study, parents will be asked to use the We3Health mobile app track their time in the NICU, time learning and time spent in infant caregiving activities and to keep of a journal of their NICU experience. |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant ≤ 33 weeks and their parent or guardian
Key exclusion criteria (4 listed)
- Infant has a life-threatening congenital anomaly, is unlikely to survive or is receiving palliative care
- Parent is not English literate
- Parent < 18 years of age
- Parent does not have access to hand-held computer (smartphone or tablet)
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 Integrated CareParents of infants assigned to mFI-Care will be trained and treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches. | Behavioural | Family Integrated Care (mFI-Care) |
Primary outcome
Change in infant weight (z-score)
Time frame: 21 days of age after enrollment
Z-score will be calculated by obtaining weight in kilograms from medical record and compared between the mFICare and usual FCC groups
9 secondary outcomes
Amount of human milk/formula supplementation
Time frame: At study enrollment and at hospital discharge, usually 21 days after admission
Frequency of breastfeeding
Time frame: At study enrollment and at hospital discharge, usually 21 days after admission
Breastfeeding rate
Time frame: At study enrollment and at hospital discharge, usually 21 days after admission
Length of stay
Time frame: Number of days of NICU and hospital stay, usually 21 days after admission
Weight gain velocity
Time frame: at NICU discharge, usually 21 days after admission
Major morbidities
Time frame: at NICU discharge, usually 21 days after admission
Parent perceived stress
Time frame: at NICU discharge, usually 21 days after admission
Parenting competence
Time frame: at NICU discharge, usually 21 days after admission
Perceived parenting self-efficacy
Time frame: at NICU discharge, usually 21 days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 26671340O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.
- Derived from this study: PubMed 38737891Franck LS, Magana J, Bisgaard R, Lothe B, Sun Y, Morton CH. Mobile-enhanced Family Integrated Care for preterm infants: A qualitative study of parents' views. PEC Innov. 2024 Apr 30;4:100284. doi: 10.1016/j.pecinn.2024.100284. eCollection 2024 Dec.
- Derived from this study: PubMed 36418988Franck LS, Gay CL, Hoffmann TJ, Kriz RM, Bisgaard R, Cormier DM, Joe P, Lothe B, Sun Y. Neonatal outcomes from a quasi-experimental clinical trial of Family Integrated Care versus Family-Centered Care for preterm infants in U.S. NICUs. BMC Pediatr. 2022 Nov 22;22(1):674. doi: 10.1186/s12887-022-03732-1.
- Derived from this study: PubMed 33966954Furtak SL, Gay CL, Kriz RM, Bisgaard R, Bolick SC, Lothe B, Cormier DM, Joe P, Sasinski JK, Kim JH, Lin CK, Sun Y, Franck LS. What parents want to know about caring for their preterm infant: A longitudinal descriptive study. Patient Educ Couns. 2021 Nov;104(11):2732-2739. doi: 10.1016/j.pec.2021.04.011. Epub 2021 Apr 17.
- Derived from this study: PubMed 31791285Franck LS, Kriz RM, Bisgaard R, Cormier DM, Joe P, Miller PS, Kim JH, Lin C, Sun Y. Comparison of family centered care with family integrated care and mobile technology (mFICare) on preterm infant and family outcomes: a multi-site quasi-experimental clinical trial protocol. BMC Pediatr. 2019 Dec 2;19(1):469. doi: 10.1186/s12887-019-1838-3.
- Individual participant dataSharing planned: No
Related trials for Premature Birth of Newborn
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
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
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.
Linda Franck, RN, PhD principal investigator
Dept of Family Care Nursing, California Preterm Birth Initiative, UCSF
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Integrated Care in people with Premature Birth of Newborn, run by University of California, San Francisco at 6 sites in United States.
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 1 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: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in infant weight (z-score) (time frame: 21 days of age after enrollment). 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 NCT03418870, which also lists 5 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 23 Mar 2021.