Premature Birth of Newborn
Conditions
Keywords
Intensive Care Units, Neonatal, Parents, Mobile application
Brief 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. 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.
Interventions
BEHAVIORALFamily Integrated Care
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.
Sponsors
University of California, Los Angeles
University of California, San Diego
Kaiser Permanente
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Phase 1 is usual care and Phase 2 is the intervention phase.
Eligibility
Sex/Gender
ALL
Age
No minimum to 33 Weeks
Healthy volunteers
No
Inclusion criteria
* Infant ≤ 33 weeks and their parent or guardian
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in infant weight (z-score) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding rate | At study enrollment and at hospital discharge, usually 21 days after admission | 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 |
| Weight gain velocity | at NICU discharge, usually 21 days after admission | number of grams gained from enrollment to specified date divided by the number of days = weight gain velocity |
| Major morbidities | at NICU discharge, usually 21 days after admission | Nosocomial infection, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, and adverse events. |
| Parent perceived stress | at NICU discharge, usually 21 days after admission | Self- reported survey |
| Parenting competence | at NICU discharge, usually 21 days after admission | self reported survey |
| Perceived parenting self-efficacy | at NICU discharge, usually 21 days after admission | self-reported survey |
| Amount of human milk/formula supplementation | At study enrollment and at hospital discharge, usually 21 days after admission | number of ml for all breast feeding, breast pumping, bottle feeding, and nasal gastric (NG) feeding will be obtained from the medical record |
| Frequency of breastfeeding | At study enrollment and at hospital discharge, usually 21 days after admission | Number of feedings for breast feeding, breast pumping, bottle feeding, and NG feeding will be obtained from the medical record |
| Length of stay | Number of days of NICU and hospital stay, usually 21 days after admission | Number of days of NICU and hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding rate | 3 months post-discharge | self-reported survey |
| Breastfeeding frequency | 3 months post-discharge | self-reported survey |
| Hospital readmission rate | 3 months post-discharge | self-reported survey |
| Perceived parenting self-efficacy | 3 months post-discharge | self-reported survey |
| Change in infant weight (z-score) | 3 months post-discharge | Z-score will be calculated by obtaining weight in kilograms from medical record and compared between the mFICare and usual FCC groups |
Countries
United States
Outcome results
None listed