Clinical trial NCT02901665: Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes
Official title: Impact of Increased Parent Presence in the NICU on Parent & Infant Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Relationship
Stress
Breastfeeding
Bottle Feeding
Complications
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Parent Salivary Cortisols
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
measure: Parent Stress Scale: NICU
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
measure: Infant Salivary Cortisol
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
Secondary outcomes:
measure: Family Visiting Rate
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
measure: Parent Kangaroo Care Rate
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
measure: Breastfeeding Rate
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
Other outcomes:
measure: Length of Stay in days
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
measure: Infant weight gain in grams/day
timeFrame: Throughout duration of NICU stay, an expected average of 4 weeks
Locations:
city: Chicago
country: United States
facility: Neonatal Intensive Care Unit, Children's Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Ann & Robert H Lurie Childrens Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Susan M Horner, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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 14.
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. doi: 10.1111/j.1365-2648.2004.03336.x.