NCT02901665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

4.1 years

First QC Date

October 9, 2014

Last Update Submit

April 2, 2019

Conditions

Family RelationshipStressBreastfeedingBottle FeedingComplications

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Infant Salivary Cortisol

    Measured at admission, every 4 weeks and at discharge

    Throughout duration of NICU stay, an expected average of 4 weeks

Secondary Outcomes (3)

  • Family Visiting Rate

    Throughout duration of NICU stay, an expected average of 4 weeks

  • Parent Kangaroo Care Rate

    Throughout duration of NICU stay, an expected average of 4 weeks

  • Breastfeeding Rate

    Throughout duration of NICU stay, an expected average of 4 weeks

Other Outcomes (2)

  • Length of Stay in days

    Throughout duration of NICU stay, an expected average of 4 weeks

  • Infant weight gain in grams/day

    Throughout duration of NICU stay, an expected average of 4 weeks

Study Arms (2)

Pre-FCC Intervention

NO INTERVENTION

Pre-intervention group. No intervention will be administered.

Post-FCC Intervention

ACTIVE COMPARATOR

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.

Other: FCC intervention

Interventions

FCC interventionOTHER

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

Post-FCC Intervention

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Less than 2 weeks of age
  • Must be admitted to NICU

You may not qualify if:

  • Previously discharged home
  • \<28 weeks gestation
  • Anticipated hospital stay \> 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neonatal Intensive Care Unit, Children's Memorial Hospital

Chicago, Illinois, 60148, United States

Location

Ann & Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related 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. doi: 10.1038/sj.jp.7211840.

    PMID: 18034178RESULT

  • 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.

    PMID: 21255703RESULT

  • 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.

    PMID: 23412640RESULT

  • 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.

    PMID: 15737221RESULT

MeSH Terms

Conditions

Breast FeedingBottle Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Susan M Horner, MS

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist - Developmental Specialist

Study Record Dates

First Submitted

October 9, 2014

First Posted

September 15, 2016

Study Start

September 1, 2014

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)