Trial Outcomes & Findings for Interventions to Help Infants Recover in the Hospital (NCT NCT03881553)
NCT ID: NCT03881553
Last Updated: 2022-06-01
Results Overview
Within each Group, percent sleep (and inversely percent wake) duration will be compared for periods of device on and device off separately for each intervention device within each study session.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Results posted on
2022-06-01
Participant Flow
Recruitment in the neonatal and pediatric hospital units where infants receiving in-patient care.
Within-subject design so each participant received periods with and without the intervention (NEATCAP and SVS mattress device). Assignment was based on equipment availability. Number of study sessions may have been related to: discharged from hospital prior to opportunity to participate in 1 or more study sessions; i.e., personnel and/or equipment availability to schedule session; Covid-19 halt on in-person subject participation; termination of project.
Participant milestones
| Measure |
Premature Infants (NICU)
Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP.
|
Opioid-Exposed Newborns (NICU)
Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP.
|
Hospitalized Infants (PICU)
Infants receiving treatment in the Pediatric Intensive Care or Inpatient Unit participated in up to 2 sessions with SVS mattress intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
2
|
4
|
|
Overall Study
COMPLETED
|
10
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Premature Infants (NICU)
Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP.
|
Opioid-Exposed Newborns (NICU)
Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP.
|
Hospitalized Infants (PICU)
Infants receiving treatment in the Pediatric Intensive Care or Inpatient Unit participated in up to 2 sessions with SVS mattress intervention.
|
|---|---|---|---|
|
Overall Study
Discharged prior to participation
|
1
|
1
|
0
|
|
Overall Study
Developed infection prior to participation--excluded per protocol criteria
|
0
|
0
|
1
|
Baseline Characteristics
Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
Baseline characteristics by cohort
| Measure |
Experimental: Premature Infants (NICU)
n=10 Participants
Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) will participate in up to 2 sessions with NEATCAP intervention and up to 2 sessions with SVS mattress intervention.
|
Experimental: Opioid-Exposed Newborns (NICU)
n=2 Participants
Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) will participate in up to 2 sessions with NEATCAP intervention and up to 2 sessions with SVS mattress intervention.
|
Experimental: Hospitalized Infants (PICU)
n=4 Participants
Infants receiving treatment in the Pediatric Intensive Care or Inpatient Unit will participate in up to 2 sessions with NEATCAP intervention and up to to 2 sessions with SVS mattress intervention.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
0 Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
0 Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
0 Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
0 Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
0 Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
0 Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Age, Continuous
Mean Gestational Age (weeks)
|
34.1 weeks
STANDARD_DEVIATION 1.3 • n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA weeks
STANDARD_DEVIATION NA • n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA weeks
STANDARD_DEVIATION NA • n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA weeks
STANDARD_DEVIATION NA • n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=1 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=3 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=14 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Race (NIH/OMB)
White
|
6 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA Participants
n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
|
Mean Post-Menstrual Age at time of 1st session
|
35.84 weeks
STANDARD_DEVIATION 1.2 • n=10 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA weeks
STANDARD_DEVIATION NA • n=2 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA weeks
STANDARD_DEVIATION NA • n=4 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
NA weeks
STANDARD_DEVIATION NA • n=16 Participants • Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection).
|
PRIMARY outcome
Timeframe: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)Within each Group, percent sleep (and inversely percent wake) duration will be compared for periods of device on and device off separately for each intervention device within each study session.
Outcome measures
| Measure |
Premature Infants (NICU)
n=10 Participants
Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP intervention
NEATCAP: NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
|
|---|---|
|
Sleep Rate With and Without NEATCAP Intervention
NEATCAP OFF1
|
79.99 percent of period sleep
Standard Deviation 19.49
|
|
Sleep Rate With and Without NEATCAP Intervention
NEATCAP ON
|
94.11 percent of period sleep
Standard Deviation 9.07
|
|
Sleep Rate With and Without NEATCAP Intervention
NEATCAP OFF2
|
75.74 percent of period sleep
Standard Deviation 25.46
|
PRIMARY outcome
Timeframe: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)Within each Group, mean respiratory rate will be compared for periods of device on and device off separately for each intervention device within each study session.
Outcome measures
| Measure |
Premature Infants (NICU)
n=10 Participants
Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP intervention
NEATCAP: NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
|
|---|---|
|
Mean Respiratory Rate With and Without Intervention
Respiratory Rate OFF1
|
66.7 breaths/min
Standard Deviation 13.6
|
|
Mean Respiratory Rate With and Without Intervention
Respiratory Rate ON
|
62.6 breaths/min
Standard Deviation 8.2
|
|
Mean Respiratory Rate With and Without Intervention
Respiratory Rate OFF2
|
64.9 breaths/min
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)Within each Group, mean heart rate will be compared for periods of device on and device off separately for each intervention device within each study session.
Outcome measures
| Measure |
Premature Infants (NICU)
n=10 Participants
Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP intervention
NEATCAP: NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
|
|---|---|
|
Mean Heart Rate With and Without Intervention
Heart Rate OFF1
|
149.8 beats/min
Standard Deviation 13.5
|
|
Mean Heart Rate With and Without Intervention
Heart Rate ON
|
151.8 beats/min
Standard Deviation 13.4
|
|
Mean Heart Rate With and Without Intervention
Heart Rate OFF2
|
149.6 beats/min
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)Within each Group, mean movement activity will be compared for periods of device on and device off separately for each intervention device within each study session.
Outcome measures
| Measure |
Premature Infants (NICU)
n=10 Participants
Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP intervention
NEATCAP: NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
|
|---|---|
|
Mean Movement Activity
Percent Movement OFF1
|
26.4 percent
Standard Deviation 6.8
|
|
Mean Movement Activity
Percent Movement ON
|
26.9 percent
Standard Deviation 8.6
|
|
Mean Movement Activity
Percent Movement OFF2
|
33.2 percent
Standard Deviation 7.0
|
Adverse Events
Premature Infants (NICU): NEATCAP Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opioid-Exposed Newborns (NICU): NEATCAP Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hospitalized Infants (PICU): Mattress Device
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
Elisabeth Salisbury, PhD
University of Pittsburgh School of Medicnie
Phone: 412-246-5378
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place