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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901665
• Other study ID #: 2014-15866 Horner
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2019
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Bottle Feeding
• Breastfeeding
• Complications
• Family Relationship
• Stress

Intervention

Other:
• FCC intervention
Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Childrens Hospital of Chicago	Chicago	Illinois
United States	Neonatal Intensive Care Unit, Children's Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. — View Citation

Franck LS, Cox S, Allen A, Winter I. Measuring neonatal intensive care unit-related parental stress. J Adv Nurs. 2005 Mar;49(6):608-15. — View Citation

Gooding JS, Cooper LG, Blaine AI, Franck LS, Howse JL, Berns SD. Family support and family-centered care in the neonatal intensive care unit: origins, advances, impact. Semin Perinatol. 2011 Feb;35(1):20-8. doi: 10.1053/j.semperi.2010.10.004. — View Citation

Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Stay in days	infant length of stay in days in the NICU from admission to discharge	Throughout duration of NICU stay, an expected average of 4 weeks
Other	Infant weight gain in grams/day	Average weight gain in grams/day throughout NICU stay	Throughout duration of NICU stay, an expected average of 4 weeks
Primary	Parent Salivary Cortisols	Salivary Cortisol levels obtained at admission, every 4 weeks and at discharge	Throughout duration of NICU stay, an expected average of 4 weeks
Primary	Parent Stress Scale: NICU	Measured at admission and discharge using validated Parent Stress Scale: NICU	Throughout duration of NICU stay, an expected average of 4 weeks
Primary	Infant Salivary Cortisol	Measured at admission, every 4 weeks and at discharge	Throughout duration of NICU stay, an expected average of 4 weeks
Secondary	Family Visiting Rate	Rate of family visiting in hours per week	Throughout duration of NICU stay, an expected average of 4 weeks
Secondary	Parent Kangaroo Care Rate	Rate of Kangaroo Care (skin to skin holding of infant by a parent) per week	Throughout duration of NICU stay, an expected average of 4 weeks
Secondary	Breastfeeding Rate	Rate of mother providing breast milk for her infant	Throughout duration of NICU stay, an expected average of 4 weeks