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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Family Relationship, Breastfeeding, Stress, Bottle Feeding, Complications

Intervention / Treatment
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* Other: FCC intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-FCC Intervention<br>Pre-intervention group. No intervention will be administered. | |
| Active Comparator: Post-FCC Intervention<br>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<br>* Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family Visiting Rate | Rate of family visiting in hours per week | Throughout duration of NICU stay, an expected average of 4 weeks | 
| Parent Kangaroo Care Rate | Rate of Kangaroo Care (skin to skin holding of infant by a parent) per week | Throughout duration of NICU stay, an expected average of 4 weeks | 
| Breastfeeding Rate | Rate of mother providing breast milk for her infant | Throughout duration of NICU stay, an expected average of 4 weeks |