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Supporting All Families of Premature Infants at Prentice Women's Hospital From Admission Through Discharge

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ClinicalTrials.gov Identifier: NCT03505424
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Friends of Prentice
Information provided by (Responsible Party):
Craig Garfield, Northwestern University

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.)

Condition or disease Intervention/treatment Phase
Premature Infant Premature Birth NICU Other: Group 1: Standard of Care Other: Group 2: NICU2HOME app Other: Group 3: SMART NICU2HOME app Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Supporting All Families of Premature Infants at Prentice Women's Hospital From Admission Through Discharge
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1: Standard of Care
Parents of infants born from April -mid-August 2018 (Group 1)
Other: Group 1: Standard of Care

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.

Active Comparator: Group 2: NICU2HOME app
Parents of infants born from mid-August 2018- January 2019 (Group 2)
Other: Group 2: NICU2HOME app
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.

Active Comparator: Group 3: SMART NICU2HOME app
Parents of infants born from February- June 2019 (Group 3)
Other: Group 3: SMART NICU2HOME app
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.




Primary Outcome Measures :
  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. [ Time Frame: 2-3 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 2-3 months ]
  2. Relationship quality will be measured through survey. [ Time Frame: 2-3 months ]

Other Outcome Measures:
  1. Patient satisfaction with the hospitalization will be measured through survey. [ Time Frame: 2-3 months ]
  2. Patient satisfaction with the discharge will be measured through survey. [ Time Frame: 2-3 months ]
  3. Social support will be measured through survey. [ Time Frame: 2-3 months ]
  4. Length of Stay will be measure. [ Time Frame: 2-3 months ]
  5. Readmission rates will be measure. [ Time Frame: 2-3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505424


Contacts
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Contact: Craig Garfield, MD (312)503-5463 c-garfield@northwestern.edu

Locations
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United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Craig Garfield, MD    312-503-5463    c-garfield@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Friends of Prentice

Publications:
Strauss, A.L., et al., Social organization of medical work. 2nd ed. 1997, New Brunswick, London: Transaction Publishers.
Glaser, B.G. and A.L. Strauss, Time for dying. 1968, Chicago, U.S.A.: Aldine

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Responsible Party: Craig Garfield, Associate Professor in Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT03505424     History of Changes
Other Study ID Numbers: STU00207127
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Craig Garfield, Northwestern University:
Premature Infant
Premature Birth
Smartphone App
NICU

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications