Bottle Feeding, Breastfeeding, Complications, Family Relationship, Stress
Conditions
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.
Interventions
OTHERFCC intervention
Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU) | 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. |
| Infant Salivary Cortisol | 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). |
| Family Visiting Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay in Days | 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). |
| Parent Kangaroo Care Rate | 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 |
| Mothers Breastfeeding Rate | Measured at NICU discharge, an average of 47 days from NICU admission. | Number of mothers providing breastmilk at NICU discharge |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan M Horner, MS
Ann & Robert H Lurie Children's Hospital of Chicago
Participant flow
Recruitment details
78 infants; 78 of the infants' mothers; 35 of the infants' fathers
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Fathers | 30.3 years STANDARD_DEVIATION 7.17 |
| Age, Continuous Infants gestational age weeks) | 36.01 weeks STANDARD_DEVIATION 3.5 |
| Age, Continuous Mothers | 29.68 years STANDARD_DEVIATION 6.26 |
| Birth weight | 2650.7 grams STANDARD_DEVIATION 782 |
| Infants Neonatal Medical Index | 3.5 units on a scale STANDARD_DEVIATION 1.31 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 91 participants |
| Sex: Female, Male Fathers' sex Female | 0 Participants |
| Sex: Female, Male Fathers' sex Male | 15 Participants |
| Sex: Female, Male Infant sex Female | 19 Participants |
| Sex: Female, Male Infant sex Male | 19 Participants |
| Sex: Female, Male Mothers' sex Female | 38 Participants |
| Sex: Female, Male Mothers' sex Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 91 |
| other Total, other adverse events | 0 / 100 | 0 / 91 |
| serious Total, serious adverse events | 0 / 100 | 0 / 91 |
Outcome results
None listed