Supporting All Families of Premature Infants At Prentice Women's Hospital from Admission Through Discharge

NCT03505424 | Completed

• 1 other identifier: STU00207127
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the extent to which the SMART NICU2HOME (including EMR interface) and the NICU2HOME apps, mobile applications designed for parents of premature infants to receive daily, real-time information about their infants and personalized education material based on parents' anticipated concerns and their infant's clinical status, is effective in: 1) improving parents' competency in caring for their sick infants, 2) reducing stress, 3) supporting parents' social supports and 3) improving NICU outcomes (parent satisfaction, length of stay, readmission rates.)

Conditions

Premature Infant; Premature Birth; NICU

Keywords

Premature Infant; Premature Birth; Smartphone App; NICU

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be the level of confidence caring for their premature infants while in the NICU and once at home measured through a survey.

  We will use the PSOC Survey for this outcome.

  2-3 months

Secondary Outcomes (2)

• The primary outcome measure will be the level of stress caring for their premature infants while in the NICU and once at home measured through a survey.

  2-3 months

• Relationship quality will be measured through survey.

  2-3 months

Other Outcomes (5)

• Patient satisfaction with the hospitalization will be measured through survey.

  2-3 months

• Patient satisfaction with the discharge will be measured through survey.

  2-3 months

• Social support will be measured through survey.

  2-3 months

Study Arms (3)

Group 1: Standard of Care

ACTIVE COMPARATOR

Parents of infants born from April -mid-August 2018 (Group 1)

Other: Group 1: Standard of Care

Group 2: NICU2HOME app

ACTIVE COMPARATOR

Parents of infants born from mid-August 2018- January 2019 (Group 2)

Other: Group 2: NICU2HOME app

Group 3: SMART NICU2HOME app

ACTIVE COMPARATOR

Parents of infants born from February- June 2019 (Group 3)

Other: Group 3: SMART NICU2HOME app

Interventions

Group 1: Standard of Care OTHER

Those who are in Group 1 will receive the usual care which includes: 1. a welcome packet from the nursing staff 2. access to their infant's medical team including doctors and nurse 3. opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.

Group 1: Standard of Care

Group 2: NICU2HOME app OTHER

In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.

Group 2: NICU2HOME app

Group 3: SMART NICU2HOME app OTHER

In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 3 parents will be asked to download the SMART NICU2HOME app.

Group 3: SMART NICU2HOME app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of premature infants (\<37 weeks) admitted to Prentice NICU
• Competent in English (i.e. to fully understand the questions asked in the surveys)
• Smartphone owner

You may not qualify if:

• None Adults unable to consent/Cognitively Impaired
• Pregnant women (where the activities of the research may affect the pregnancy or the fetus)
• Prisoners or other detained individuals

Sponsors & Collaborators

• Northwestern University: lead
• Friends of Prentice: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (13)

• Hamilton BE Ph D, Martin JA, Osterman MJ M H S, Curtain SC M A. Births: Preliminary Data for 2014. Natl Vital Stat Rep. 2015 Jun;64(6):1-19.

  PMID: 26114874 BACKGROUND

• Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/

  PMID: 20669423 BACKGROUND

• Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021.

  PMID: 24927295 BACKGROUND

• Obeidat HM, Bond EA, Callister LC. The parental experience of having an infant in the newborn intensive care unit. J Perinat Educ. 2009 Summer;18(3):23-9. doi: 10.1624/105812409X461199.

  PMID: 20514124 BACKGROUND

• De Rouck S, Leys M. Information needs of parents of children admitted to a neonatal intensive care unit: a review of the literature (1990-2008). Patient Educ Couns. 2009 Aug;76(2):159-73. doi: 10.1016/j.pec.2009.01.014. Epub 2009 Mar 24.

  PMID: 19321288 BACKGROUND

• Strauss, A.L., et al., Social organization of medical work. 2nd ed. 1997, New Brunswick, London: Transaction Publishers.

  BACKGROUND

• Glaser, B.G. and A.L. Strauss, Time for dying. 1968, Chicago, U.S.A.: Aldine

  BACKGROUND

• Ward K. Perceived needs of parents of critically ill infants in a neonatal intensive care unit (NICU). Pediatr Nurs. 2001 May-Jun;27(3):281-6.

  PMID: 12964668 BACKGROUND

• Heermann JA, Wilson ME, Wilhelm PA. Mothers in the NICU: outsider to partner. Pediatr Nurs. 2005 May-Jun;31(3):176-81, 200.

  PMID: 16060580 BACKGROUND

• Dhillon AS, Albersheim SG, Alsaad S, Pargass NS, Zupancic JA. Internet use and perceptions of information reliability by parents in a neonatal intensive care unit. J Perinatol. 2003 Jul-Aug;23(5):420-4. doi: 10.1038/sj.jp.7210945.

  PMID: 12847540 BACKGROUND

• Kowalski WJ, Leef KH, Mackley A, Spear ML, Paul DA. Communicating with parents of premature infants: who is the informant? J Perinatol. 2006 Jan 1;26(1):44-8. doi: 10.1038/sj.jp.7211409.

  PMID: 16292336 BACKGROUND

• Garfield CF, Kerrigan E, Christie R, Jackson KL, Lee YS. A Mobile Health Intervention to Support Parenting Self-Efficacy in the Neonatal Intensive Care Unit from Admission to Home. J Pediatr. 2022 May;244:92-100. doi: 10.1016/j.jpeds.2022.01.004. Epub 2022 Jan 13.

  PMID: 35033562 DERIVED

• Garfield CF, Lee YS, Warner-Shifflett L, Christie R, Jackson KL, Miller E. Maternal and Paternal Depression Symptoms During NICU Stay and Transition Home. Pediatrics. 2021 Aug;148(2):e2020042747. doi: 10.1542/peds.2020-042747. Epub 2021 Jun 18.

  PMID: 34341101 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pediatrics

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 23, 2018
• Study Start: April 20, 2018
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)