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Trial record 1 of 1 for:    NCT02901665
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Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes

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ClinicalTrials.gov Identifier: NCT02901665
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Susan M Horner, MS, APN/CNS, RNC-NIC, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Condition or disease Intervention/treatment Phase
Family Relationship Stress Breastfeeding Bottle Feeding Complications Other: FCC intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Increased Parent Presence in the NICU on Parent & Infant Outcomes
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Arm Intervention/treatment
No Intervention: Pre-FCC Intervention
Pre-intervention group. No intervention will be administered.
Active Comparator: 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.
Other: FCC intervention
Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.




Primary Outcome Measures :
  1. Parent Salivary Cortisols [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Salivary Cortisol levels obtained at admission, every 4 weeks and at discharge

  2. Parent Stress Scale: NICU [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Measured at admission and discharge using validated Parent Stress Scale: NICU

  3. Infant Salivary Cortisol [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Measured at admission, every 4 weeks and at discharge


Secondary Outcome Measures :
  1. Family Visiting Rate [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Rate of family visiting in hours per week

  2. Parent Kangaroo Care Rate [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Rate of Kangaroo Care (skin to skin holding of infant by a parent) per week

  3. Breastfeeding Rate [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Rate of mother providing breast milk for her infant


Other Outcome Measures:
  1. Length of Stay in days [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    infant length of stay in days in the NICU from admission to discharge

  2. Infant weight gain in grams/day [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Average weight gain in grams/day throughout NICU stay



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901665


Locations
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United States, Illinois
Neonatal Intensive Care Unit, Children's Memorial Hospital
Chicago, Illinois, United States, 60148
Ann & Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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Principal Investigator: Susan M Horner, MS Ann & Robert H Lurie Children's Hospital of Chicago