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

NCT ID: NCT02901665

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2018-09-30

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.

Conditions

Family Relationship; Stress; Breastfeeding; Bottle Feeding; Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pre-FCC Intervention

Pre-intervention group. No intervention will be administered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-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.

Group Type: ACTIVE_COMPARATOR

FCC intervention

Intervention Type: OTHER

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

Interventions

FCC intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

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

Clinical Nurse Specialist - Developmental Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan M Horner, MS

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Neonatal Intensive Care Unit, Children's Memorial Hospital

Chicago, Illinois, United States

Ann & Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

References

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. doi: 10.1038/sj.jp.7211840.

Reference Type: RESULT

PMID: 18034178 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21255703 (View on PubMed)

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 14.

Reference Type: RESULT

PMID: 23412640 (View on PubMed)

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. doi: 10.1111/j.1365-2648.2004.03336.x.

Reference Type: RESULT

PMID: 15737221 (View on PubMed)

Other Identifiers

2014-15866 Horner

Identifier Type: -

Identifier Source: org_study_id