Trial Outcomes & Findings for Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes (NCT NCT02901665)
NCT ID: NCT02901665
Last Updated: 2026-05-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
191 participants
Primary outcome timeframe
Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Results posted on
2026-05-29
Participant Flow
78 infants; 78 of the infants' mothers; 35 of the infants' fathers
Participant milestones
| Measure |
Pre-FCC Intervention
Pre-intervention group. No intervention will be administered.
|
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
91
|
|
Overall Study
NICU Infants
|
40
|
38
|
|
Overall Study
Mothers of Enrolled Infants
|
40
|
38
|
|
Overall Study
Fathers of Enrolled Infants
|
20
|
15
|
|
Overall Study
COMPLETED
|
100
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Population differs in that only enrolled Infants reported here (N=78; 40 pre, 38 post-intervention).
Baseline characteristics by cohort
| Measure |
Pre-FCC Intervention
n=100 Participants
Pre-intervention group. No intervention was administered.
|
Post-FCC Intervention
n=91 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Infants gestational age weeks)
|
36.03 weeks
STANDARD_DEVIATION 3.75 • n=40 Participants • Population differs in that only enrolled Infants reported here (N=78; 40 pre, 38 post-intervention).
|
36 weeks
STANDARD_DEVIATION 3.28 • n=38 Participants • Population differs in that only enrolled Infants reported here (N=78; 40 pre, 38 post-intervention).
|
36.01 weeks
STANDARD_DEVIATION 3.5 • n=78 Participants • Population differs in that only enrolled Infants reported here (N=78; 40 pre, 38 post-intervention).
|
|
Birth weight
|
2650.7 grams
STANDARD_DEVIATION 782 • n=40 Participants • Only infants birth weights analyzed. N=40 (pre) and 38 (post)
|
2730.2 grams
STANDARD_DEVIATION 939 • n=38 Participants • Only infants birth weights analyzed. N=40 (pre) and 38 (post)
|
2689.42 grams
STANDARD_DEVIATION 857.29 • n=78 Participants • Only infants birth weights analyzed. N=40 (pre) and 38 (post)
|
|
Age, Continuous
Mothers
|
29.68 years
STANDARD_DEVIATION 6.26 • n=40 Participants • Numbers differ from overall because only enrolled Mothers (N=78; 40 pre, 38 post-intervention) and enrolled Fathers (N=35; 20 pre, 15 post-intervention) are reported here.
|
30.03 years
STANDARD_DEVIATION 6.12 • n=38 Participants • Numbers differ from overall because only enrolled Mothers (N=78; 40 pre, 38 post-intervention) and enrolled Fathers (N=35; 20 pre, 15 post-intervention) are reported here.
|
29.85 years
STANDARD_DEVIATION 6.15 • n=78 Participants • Numbers differ from overall because only enrolled Mothers (N=78; 40 pre, 38 post-intervention) and enrolled Fathers (N=35; 20 pre, 15 post-intervention) are reported here.
|
|
Age, Continuous
Fathers
|
30.3 years
STANDARD_DEVIATION 7.17 • n=20 Participants • Numbers differ from overall because only enrolled Mothers (N=78; 40 pre, 38 post-intervention) and enrolled Fathers (N=35; 20 pre, 15 post-intervention) are reported here.
|
32.87 years
STANDARD_DEVIATION 5.1 • n=15 Participants • Numbers differ from overall because only enrolled Mothers (N=78; 40 pre, 38 post-intervention) and enrolled Fathers (N=35; 20 pre, 15 post-intervention) are reported here.
|
31.4 years
STANDARD_DEVIATION 6.41 • n=35 Participants • Numbers differ from overall because only enrolled Mothers (N=78; 40 pre, 38 post-intervention) and enrolled Fathers (N=35; 20 pre, 15 post-intervention) are reported here.
|
|
Sex: Female, Male
Infant sex · Female
|
23 Participants
n=40 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
19 Participants
n=38 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
42 Participants
n=78 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
|
Sex: Female, Male
Infant sex · Male
|
17 Participants
n=40 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
19 Participants
n=38 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
36 Participants
n=78 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
|
Sex: Female, Male
Mothers' sex · Female
|
40 Participants
n=40 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
38 Participants
n=38 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
78 Participants
n=78 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
|
Sex: Female, Male
Mothers' sex · Male
|
0 Participants
n=40 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
0 Participants
n=38 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
0 Participants
n=78 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
|
Sex: Female, Male
Fathers' sex · Female
|
0 Participants
n=20 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
0 Participants
n=15 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
0 Participants
n=35 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
|
Sex: Female, Male
Fathers' sex · Male
|
20 Participants
n=20 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
15 Participants
n=15 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
35 Participants
n=35 Participants • Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post)
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
100 participants
n=100 Participants
|
91 participants
n=91 Participants
|
191 participants
n=191 Participants
|
|
Infants Neonatal Medical Index
|
3.73 units on a scale
STANDARD_DEVIATION 1.22 • n=40 Participants • Only infant participants measured using Neonatal Medical Index Pre-intervention = 40; Post-intervention = 38
|
3.5 units on a scale
STANDARD_DEVIATION 1.31 • n=38 Participants • Only infant participants measured using Neonatal Medical Index Pre-intervention = 40; Post-intervention = 38
|
3.62 units on a scale
STANDARD_DEVIATION 1.26 • n=78 Participants • Only infant participants measured using Neonatal Medical Index Pre-intervention = 40; Post-intervention = 38
|
PRIMARY outcome
Timeframe: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.Population: Enrolled mothers and fathers
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.
Outcome measures
| Measure |
Pre-FCC Intervention
n=32 Participants
Pre-intervention group. No intervention will be administered.
|
Post-FCC Intervention
n=32 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Fathers Pre-FCC Intervention
n=17 Participants
Fathers enrolled pre-FCC intervention
|
Fathers Post-FCC Interventio
n=14 Participants
Fathers enrolled post-FCC intervention
|
|---|---|---|---|---|
|
Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
At baseline (at infant NICU admission at birth)
|
2.86 score on a scale
Standard Deviation 0.93
|
2.48 score on a scale
Standard Deviation 0.68
|
3.19 score on a scale
Standard Deviation 1.05
|
2.23 score on a scale
Standard Deviation 0.79
|
|
Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
At NICU discharge, average 47 days
|
2.8 score on a scale
Standard Deviation 0.88
|
2.14 score on a scale
Standard Deviation 0.84
|
2.74 score on a scale
Standard Deviation 0.97
|
1.96 score on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Pre-FCC Intervention
n=35 Participants
Pre-intervention group. No intervention will be administered.
|
Post-FCC Intervention
n=33 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Fathers Pre-FCC Intervention
Fathers enrolled pre-FCC intervention
|
Fathers Post-FCC Interventio
Fathers enrolled post-FCC intervention
|
|---|---|---|---|---|
|
Infant Salivary Cortisol
Salivary cortisol at NICU admission
|
5.3 nanograms per milliliter (ng/ml)
Standard Deviation 8.71
|
1.79 nanograms per milliliter (ng/ml)
Standard Deviation 2.1
|
—
|
—
|
|
Infant Salivary Cortisol
Salivary cortisol at NICU discharge
|
1.93 nanograms per milliliter (ng/ml)
Standard Deviation 2.77
|
1.46 nanograms per milliliter (ng/ml)
Standard Deviation 1.58
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.Population: Analysis conducted per infant
Rate of family visiting in hours per day
Outcome measures
| Measure |
Pre-FCC Intervention
n=40 Participants
Pre-intervention group. No intervention will be administered.
|
Post-FCC Intervention
n=38 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Fathers Pre-FCC Intervention
Fathers enrolled pre-FCC intervention
|
Fathers Post-FCC Interventio
Fathers enrolled post-FCC intervention
|
|---|---|---|---|---|
|
Family Visiting Rate
|
6.19 hours per day
Standard Deviation 3.50
|
6.71 hours per day
Standard Deviation 3.07
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.Population: Enrolled infants
Infant length of stay in days in the NICU. Measured from baseline (NICU admission at birth) to NICU discharge (an average of 47 days).
Outcome measures
| Measure |
Pre-FCC Intervention
n=40 Participants
Pre-intervention group. No intervention will be administered.
|
Post-FCC Intervention
n=38 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Fathers Pre-FCC Intervention
Fathers enrolled pre-FCC intervention
|
Fathers Post-FCC Interventio
Fathers enrolled post-FCC intervention
|
|---|---|---|---|---|
|
Length of Stay in Days
|
48.2 days
Standard Deviation 45.4
|
45.4 days
Standard Deviation 45.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.Population: Enrolled infants
Rate of Kangaroo Care (skin to skin holding of infant by a parent) in hours per day
Outcome measures
| Measure |
Pre-FCC Intervention
n=40 Participants
Pre-intervention group. No intervention will be administered.
|
Post-FCC Intervention
n=38 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Fathers Pre-FCC Intervention
Fathers enrolled pre-FCC intervention
|
Fathers Post-FCC Interventio
Fathers enrolled post-FCC intervention
|
|---|---|---|---|---|
|
Parent Kangaroo Care Rate
|
0.11 hours per day
Standard Deviation 0.19
|
0.15 hours per day
Standard Deviation 0.24
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at NICU discharge, an average of 47 days from NICU admission.Population: Population differs in that only enrolled mothers were analyzed (N=78; 40 pre, 38 post)
Number of mothers providing breastmilk at NICU discharge
Outcome measures
| Measure |
Pre-FCC Intervention
n=40 Participants
Pre-intervention group. No intervention will be administered.
|
Post-FCC Intervention
n=38 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Fathers Pre-FCC Intervention
Fathers enrolled pre-FCC intervention
|
Fathers Post-FCC Interventio
Fathers enrolled post-FCC intervention
|
|---|---|---|---|---|
|
Mothers Breastfeeding Rate
|
28 Participants
|
29 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.Average weight gain in grams/day measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Outcome measures
| Measure |
Pre-FCC Intervention
n=40 Participants
Pre-intervention group. No intervention will be administered.
|
Post-FCC Intervention
n=38 Participants
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.
FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
|
Fathers Pre-FCC Intervention
Fathers enrolled pre-FCC intervention
|
Fathers Post-FCC Interventio
Fathers enrolled post-FCC intervention
|
|---|---|---|---|---|
|
Infant Weight Gain in Grams/Day
|
14.75 grams/day
Standard Deviation 16.59
|
10.23 grams/day
Standard Deviation 19.18
|
—
|
—
|
Adverse Events
Post-FCC Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-FCC Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Susan Horner, Developmental Specialist, NICU
Ann & Robert H. Lurie Children's Hospital
Phone: 13122271452
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place