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

Not Applicable

Completed

• Conditions: Stress; Family Relationship; Breastfeeding; Bottle Feeding; Complications
• Interventions: Other: FCC intervention

• Registration Number: NCT02901665
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2016-09-11
• Study First Posted: 2016-09-15
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-FCC Intervention	FCC intervention	Following unit-wide implementation of FCC intervention consisting of communicating to families an expectation that they spend 4 hours per day in the NICU with their infants.

Primary Outcome Measures

Name	Time	Method
Parent Salivary Cortisols	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	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	Throughout duration of NICU stay, an expected average of 4 weeks	Measured at admission, every 4 weeks and at discharge

Secondary Outcome Measures

Name	Time	Method
Family Visiting Rate	Throughout duration of NICU stay, an expected average of 4 weeks	Rate of family visiting in hours per week
Parent Kangaroo Care Rate	Throughout duration of NICU stay, an expected average of 4 weeks	Rate of Kangaroo Care (skin to skin holding of infant by a parent) per week
Breastfeeding Rate	Throughout duration of NICU stay, an expected average of 4 weeks	Rate of mother providing breast milk for her infant

Trial Locations

Locations (2)

Ann & Robert H Lurie Childrens Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Neonatal Intensive Care Unit, Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States