Skip to main content
Clinical Trials/NCT02901665
NCT02901665
Completed
Not Applicable

Impact of Increased Parent Presence in the NICU on Parent & Infant Outcomes

Ann & Robert H Lurie Children's Hospital of Chicago2 sites in 1 country78 target enrollmentSeptember 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Family Relationship
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
78
Locations
2
Primary Endpoint
Parent Salivary Cortisols
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence.

Detailed Description

Family centered care (FCC) is becoming the standard of care in the Neonatal Intensive Care Unit (NICU) and many benefits of FCC programs are reported in the literature. However, the integration of FCC practices remains inconsistent in NICUs and many families do not fully access available FCC supports. As a result NICU families continue to report feelings of powerlessness, stress, depression and lack of confidence in their ability to care for their infants at home. Studies of increased family presence in the NICU (8hours/day and 24/hours/day) have reported promising results for infants and families, but these studies report on programs implemented outside of the US. It is not known whether a program requiring fewer hours/day of parent presence, which may be a better fit with current US family demographics and policies, would demonstrate similar benefits. The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the NICU. The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence. Following informed consent, data will be collected on up to 45 NICU infants and families pre- and post- the intervention for a total sample of up to 90. Infant measures will include Salivary Cortisol levels, Infant weight gain, Length of Stay and Feeding route at discharge as well as rates of Family Visiting, Traditional Holding, Kangaroo Care (KC), and Breastfeeding. Parent measures will include Salivary Cortisol Levels and reported stress using the Parent Stress Scale: NICU. Unit-wide data will also be collected pre- and post- the intervention. Unit wide measures will include rates of Visitation, KC, Breastfeeding, Nosocomial Infections, IV infiltrates, Medication Errors and Incident (SERS) report rates.

Registry
clinicaltrials.gov
Start Date
September 1, 2014
End Date
September 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan M Horner, MS, APN/CNS, RNC-NIC

Clinical Nurse Specialist - Developmental Specialist

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

Inclusion Criteria

  • Less than 2 weeks of age
  • Must be admitted to NICU

Exclusion Criteria

  • Previously discharged home
  • \<28 weeks gestation
  • Anticipated hospital stay \> 3 months

Outcomes

Primary Outcomes

Parent Salivary Cortisols

Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks

Salivary Cortisol levels obtained at admission, every 4 weeks and at discharge

Parent Stress Scale: NICU

Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks

Measured at admission and discharge using validated Parent Stress Scale: NICU

Infant Salivary Cortisol

Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks

Measured at admission, every 4 weeks and at discharge

Secondary Outcomes

  • Family Visiting Rate(Throughout duration of NICU stay, an expected average of 4 weeks)
  • Parent Kangaroo Care Rate(Throughout duration of NICU stay, an expected average of 4 weeks)
  • Breastfeeding Rate(Throughout duration of NICU stay, an expected average of 4 weeks)

Study Sites (2)

Loading locations...

Similar Trials