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

NCT02901665 | Completed Results

• 1 other identifier: 2014-15866 Horner
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 2

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.

Conditions

Family Relationship; Stress; Breastfeeding; Bottle Feeding; Complications

Outcome Measures

Primary Outcomes (3)

• Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)

  Measured at baseline (NICU admission, from birth to 2 weeks of infant age) and at NICU discharge, an average of 47 days using validated Parent Stressor Scale: Neonatal Intensive Care Unit. Measure uses a 5 level Likert scale from not experienced (0) to extremely stressful (4). Higher score indicated more stress experienced. Total score used was calculated using average of subscale scores. Total score range also 0-4 units on scale.

  Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.

• Infant Salivary Cortisol

  Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days in Nanograms per milliliter (ng/ml).

  Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.

• Family Visiting Rate

  Rate of family visiting in hours per day

  Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.

Secondary Outcomes (3)

• Length of Stay in Days

  Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.

• Parent Kangaroo Care Rate

  Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.

• Mothers Breastfeeding Rate

  Measured at NICU discharge, an average of 47 days from NICU admission.

Other Outcomes (1)

• Infant Weight Gain in Grams/Day

  Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.

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 intervention OTHER

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

Post-FCC Intervention

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

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: 18034178 RESULT

• 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: 21255703 RESULT

• 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: 23412640 RESULT

• 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: 15737221 RESULT

MeSH Terms

Conditions

Breast Feeding; Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Limitations and Caveats

Use of electronic medical record (EMR) data may have resulted in biased documentation. EMR data did not differentiate between maternal and paternal presence and kangaroo care. EMR data may have inflated parent presence and kangaroo care numbers in that nurses may have documented "present" instead of a time during an hour. Single site study.

Results Point of Contact

• Title: Dr. Susan Horner, Developmental Specialist, NICU
• Organization: Ann & Robert H. Lurie Children's Hospital

shorner@luriechildrens.org

13122271452

Study Officials

• Susan M Horner, MS

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)