Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology

NCT03418870 | Completed

• 1 other identifier: 16-19542
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 6

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.

Conditions

Premature Birth of Newborn

Keywords

Intensive Care Units, Neonatal; Parents; Mobile application

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Amount of human milk/formula supplementation

  At study enrollment and at hospital discharge, usually 21 days after admission

• Frequency of breastfeeding

  At study enrollment and at hospital discharge, usually 21 days after admission

• Breastfeeding rate

  At study enrollment and at hospital discharge, usually 21 days after admission

• Length of stay

  Number of days of NICU and hospital stay, usually 21 days after admission

• Weight gain velocity

  at NICU discharge, usually 21 days after admission

Other Outcomes (5)

• Change in infant weight (z-score)

  3 months post-discharge

• Breastfeeding rate

  3 months post-discharge

• Breastfeeding frequency

  3 months post-discharge

Study Arms (2)

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.

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.

Interventions

Family Integrated Care BEHAVIORAL

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.

Family Integrated Care (mFI-Care)

Eligibility Criteria

• Age: Up to 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant ≤ 33 weeks and their parent or guardian

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Los Angeles: collaborator
• University of California, San Diego: collaborator
• Kaiser Permanente: collaborator

Study Sites (6)

Community Regional Medical Center

Fresno, California, 93721, United States

Location

Jacobs Medical Center, UC San Diego Health

La Jolla, California, 92037, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

UCSF Benioff Children's Hospital San Francisco

San Francisco, California, 94158, United States

Location

Kaiser Permanente - Santa Clara

Santa Clara, California, 95051, United States

Location

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

Location

Related Publications (5)

• 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.

  PMID: 26671340 BACKGROUND

• Franck 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.

  PMID: 38737891 DERIVED

• Franck 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.

  PMID: 36418988 DERIVED

• Furtak 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.

  PMID: 33966954 DERIVED

• Franck 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.

  PMID: 31791285 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Linda Franck, RN, PhD

  Dept of Family Care Nursing, California Preterm Birth Initiative, UCSF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1 is "usual care" and Phase 2 is the intervention phase.

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: February 1, 2018
• Study Start: April 3, 2017
• Primary Completion: January 31, 2021
• Study Completion: March 15, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)