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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

Tracking Information
First Submitted Date  ICMJE October 9, 2014
First Posted Date  ICMJE September 15, 2016
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE September 1, 2014
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2016)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02901665 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2016)
  • Family Visiting Rate [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Rate of family visiting in hours per week
  • 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
  • Breastfeeding Rate [ Time Frame: Throughout duration of NICU stay, an expected average of 4 weeks ]
    Rate of mother providing breast milk for her infant
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 11, 2016)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes
Official Title  ICMJE Impact of Increased Parent Presence in the NICU on Parent & Infant Outcomes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Family Relationship
  • Stress
  • Breastfeeding
  • Bottle Feeding
  • Complications
Intervention  ICMJE Other: FCC intervention
Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
Study Arms  ICMJE
  • 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.
    Intervention: Other: FCC intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2018)
78
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2016)
90
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02901665
Other Study ID Numbers  ICMJE 2014-15866 Horner
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Susan M Horner, MS, APN/CNS, RNC-NIC, Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor  ICMJE Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan M Horner, MS Ann & Robert H Lurie Children's Hospital of Chicago
PRS Account Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP