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

Ann & Robert H Lurie Children's Hospital of Chicago logo

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Completed

Conditions

Family Relationship
Breastfeeding
Complications
Bottle Feeding
Stress

Treatments

Other: FCC intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02901665
2014-15866 Horner

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

All

Ages

1 day to 3 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Pre-FCC Intervention
No Intervention group
Description:
Pre-intervention group. No intervention will be administered.
Post-FCC Intervention
Active Comparator group
Description:
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.
Treatment:
Other: FCC intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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