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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03418870
Other study ID # 16-19542
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2017
Est. completion date March 15, 2021

Study information

Verified date March 2021
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 347
Est. completion date March 15, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 33 Weeks
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Family 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.

Locations

Country Name City State
United States Community Regional Medical Center Fresno California
United States Jacobs Medical Center, UC San Diego Health La Jolla California
United States UCSF Benioff Children's Hospital Oakland Oakland California
United States UCSF Benioff Children's Hospital San Francisco San Francisco California
United States Kaiser Permanente - Santa Clara Santa Clara California
United States UCLA Medical Center, Santa Monica Santa Monica California

Sponsors (4)

Lead Sponsor Collaborator
University of California, San Francisco Kaiser Permanente, University of California, Los Angeles, University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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 3 months post-discharge
Other Breastfeeding rate self-reported survey 3 months post-discharge
Other Breastfeeding frequency self-reported survey 3 months post-discharge
Other Hospital readmission rate self-reported survey 3 months post-discharge
Other Perceived parenting self-efficacy self-reported survey 3 months post-discharge
Primary 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 21 days of age after enrollment
Secondary 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 At study enrollment and at hospital discharge, usually 21 days after admission
Secondary Frequency of breastfeeding Number of feedings for breast feeding, breast pumping, bottle feeding, and NG feeding will be obtained from the medical record At study enrollment and at hospital discharge, usually 21 days after admission
Secondary 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 At study enrollment and at hospital discharge, usually 21 days after admission
Secondary Length of stay Number of days of NICU and hospital stay Number of days of NICU and hospital stay, usually 21 days after admission
Secondary Weight gain velocity number of grams gained from enrollment to specified date divided by the number of days = weight gain velocity at NICU discharge, usually 21 days after admission
Secondary Major morbidities Nosocomial infection, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, and adverse events. at NICU discharge, usually 21 days after admission
Secondary Parent perceived stress Self- reported survey at NICU discharge, usually 21 days after admission
Secondary Parenting competence self reported survey at NICU discharge, usually 21 days after admission
Secondary Perceived parenting self-efficacy self-reported survey at NICU discharge, usually 21 days after admission
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