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Completed

NCT Number: NCT02901665

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

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.

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Key information

Conditions

Family Relationship Behavior Bottle Feeding Breast Feeding Breastfeeding Complications Feeding Behavior Stress

Age range

1 day–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FCC intervention

Other

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

Primary outcomes

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

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

    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.

  2. Infant Salivary Cortisol

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

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

  3. Family Visiting Rate

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

    Rate of family visiting in hours per day

Secondary outcomes

  1. Length of Stay in Days

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

    Infant length of stay in days in the NICU. Measured from baseline (NICU admission at birth) to NICU discharge (an average of 47 days).

  2. Parent Kangaroo Care Rate

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

    Rate of Kangaroo Care (skin to skin holding of infant by a parent) in hours per day

  3. Mothers Breastfeeding Rate

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

    Number of mothers providing breastmilk at NICU discharge

Other outcomes

  1. Infant Weight Gain in Grams/Day

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

    Average weight gain in grams/day measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2016
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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