Family RelationshipNCT02901665
Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes
A study testing FCC intervention in people with Family Relationship and Stress, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Family Relationship, Stress, Breastfeeding
- What is being tested?
- FCC intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2014to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 2 weeks of age
- Must be admitted to NICU
Who cannot join
- Previously discharged home
- <28 weeks gestation
- Anticipated hospital stay > 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Neonatal Intensive Care Unit, Children's Memorial Hospital
Chicago, Illinois, 60148
Ann & Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Impact of Increased Parent Presence in the NICU on Parent & Infant Outcomes
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.
Read the 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.
- Conditions
- Family Relationship, Stress, Breastfeeding, Bottle Feeding, Complications
- Being tested
- FCC intervention
- Medical subject headings
- Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCC interventionOther
Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
| Study group | Role | What they receive |
|---|---|---|
| Pre-FCC Intervention | No intervention | Pre-intervention group. No intervention will be administered. |
| Post-FCC Intervention | Active comparator | 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. Receives: Other: FCC intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
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.
Measured: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Infant Salivary Cortisol
Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days in Nanograms per milliliter (ng/ml).
Measured: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Family Visiting Rate
Rate of family visiting in hours per day
Measured: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Secondary outcomes (3)
Length of Stay in 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).
Measured: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Parent Kangaroo Care Rate
Rate of Kangaroo Care (skin to skin holding of infant by a parent) in hours per day
Measured: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Mothers Breastfeeding Rate
Number of mothers providing breastmilk at NICU discharge
Measured: Measured at NICU discharge, an average of 47 days from NICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start1 Sep 2014
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Family RelationshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Horner, PhD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Susan M Horner, MS, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901665
- Sponsor's protocol ID
- 2014-15866 Horner
- Other IDs
- 2014
- Status last verified
- May 2026
- First submitted
- 9 Oct 2014
- Last updated
- 29 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840.
PubMed 18034178Gooding JS, Cooper LG, Blaine AI, Franck LS, Howse JL, Berns SD. Family support and family-centered care in the neonatal intensive care unit: origins, advances, impact. Semin Perinatol. 2011 Feb;35(1):20-8. doi: 10.1053/j.semperi.2010.10.004.
PubMed 21255703Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb 14.
PubMed 23412640Franck LS, Cox S, Allen A, Winter I. Measuring neonatal intensive care unit-related parental stress. J Adv Nurs. 2005 Mar;49(6):608-15. doi: 10.1111/j.1365-2648.2004.03336.x.
PubMed 15737221
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Increased Parent Presence in the NICU on Parent & Infant Outcomes
- ClinicalTrials.gov ID
- NCT02901665
- Acronym / sponsor ID
- 2014-15866 Horner
- Conditions
- Family Relationship, Stress, Breastfeeding, Bottle Feeding, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-FCC Intervention | No intervention | –Pre-intervention group. No intervention will be administered. |
| Post-FCC Intervention | Active comparator | Other: FCC interventionFollowing 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. |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Less than 2 weeks of age
- Must be admitted to NICU
Key exclusion criteria (3 listed)
- Previously discharged home
- <28 weeks gestation
- Anticipated hospital stay > 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCC interventionCommunication to all NICU families that they should be in the NICU a minimum of 4 hours/day. | Other | Post-FCC Intervention |
Primary outcome
Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
Time frame: 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
Time frame: 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
Time frame: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Rate of family visiting in hours per day
3 secondary outcomes
Length of Stay in Days
Time frame: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Parent Kangaroo Care Rate
Time frame: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Mothers Breastfeeding Rate
Time frame: Measured at NICU discharge, an average of 47 days from NICU admission.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18034178Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840.
- Results publication: PubMed 21255703Gooding JS, Cooper LG, Blaine AI, Franck LS, Howse JL, Berns SD. Family support and family-centered care in the neonatal intensive care unit: origins, advances, impact. Semin Perinatol. 2011 Feb;35(1):20-8. doi: 10.1053/j.semperi.2010.10.004.
- Results publication: PubMed 23412640Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb 14.
- Results publication: PubMed 15737221Franck LS, Cox S, Allen A, Winter I. Measuring neonatal intensive care unit-related parental stress. J Adv Nurs. 2005 Mar;49(6):608-15. doi: 10.1111/j.1365-2648.2004.03336.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Horner, MS principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCC intervention in people with Family Relationship and Stress, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU) (time frame: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901665, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.