Clinical Trials Directory

Trials / Completed

CompletedNCT02901665

Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
78 (actual)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
Sex
All
Age
1 Day – 3 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERFCC interventionCommunication to all NICU families that they should be in the NICU a minimum of 4 hours/day.

Timeline

Start date
2014-09-01
Primary completion
2018-09-30
Completion
2018-09-30
First posted
2016-09-15
Last updated
2019-04-04

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02901665. Inclusion in this directory is not an endorsement.