Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology

Premature Birth of Newborn Clinical Trial

— mFI-Care  

Official title:

Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418870
• Other study ID #: 16-19542
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Premature Birth
• Premature Birth of Newborn

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