Infant Apnea, Neonatal Abstinence Syndrome, Sleep
Conditions
Keywords
Prematurity, Neonatal Abstinence Syndrome, Autonomic Function, Sleep, Stochastic Resonance, Newborn/Infant
Brief summary
This pilot project will evaluate independently two non-pharmacological interventions, 1) Neurosensory, Environmental Adaptive Technology (NEATCAP) and 2) Stochastic Vibrotactile Stimulation (SVS), as adjuvant non-pharmacological interventions for improving sleep and cardio-respiratory function in hospitalized infants. Within-subject design allows subjects to serve as their own control and receive periods of routine care with and without intervention. One intervention will be evaluated per study session. Infants may participate in up to four sessions.
Detailed description
Infants and children treated in the hospital often present with autonomic and sleep disturbances that may be related to prematurity, opioid and other drug exposures in utero, illness, surgery, medical procedures, and/or treatment medications. In addition, patients treated in neonatal and pediatric units often require prolonged hospitalization with medical monitoring and life-sustaining devices equipped with patient safety alarms. Such bedside equipment may result in patients being exposed to loud and/or persistent noises that may further disrupt sleep and autonomic function and compromise recovery and outcomes. This pilot study will study three separate pediatric populations being treated in neonatal and pediatric hospital units: 1) Premature Infants; 2) Opioid-exposed newborns requiring medication for Neonatal Abstinence Syndrome; and 3) Hospitalized infants treated for illness or surgery. Subjects will participate in up to 4 study sessions during their hospitalization, testing independent effects of two interventions complementary to routine care: 1) Neurosensory, Environmental Adaptive Technology (NEATCAP), and 2) stochastic vibrotactile stimulation (SVS). Within-subject design will allow for comparisons between periods, i.e., with and without the study-session intervention, separately for each device, for improving sleep and cardio-respiratory function in three independent groups of hospitalized infants.
Interventions
DEVICENEATCAP
NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
DEVICESVS mattress
SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Elisabeth Salisbury, PhD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Within-subjects design. Each subject will serve as own control and receive periods of intervention and no intervention within a study session.
Eligibility
Sex/Gender
ALL
Age
2 Days to 3 Years
Healthy volunteers
No
Inclusion criteria
* Pre-term infants (\>30 wks PMA) and full-term newborns receiving care since birth in the NICU/CCN. * Infants/Children receiving care in the PICU/PIU (may have had a history of prematurity). * May be with or without in utero opioid exposure and/or other drug exposure (prescribed or illicit). * May have received or be receiving opioids and/or other treatment medications as part of their medical-care plan. * Infants and children on respiratory support and/or with medical complications will not be excluded if these complications are potentially reversible.
Exclusion criteria
* Congenital anomalies of the head and/or neck. * Significant cranial trauma. * Hydrocephalus. * Current or history of intraventricular hemorrhage\>grade 2. * Clinically significant cardiac shunt. * Hemodynamic instability requiring pharmacological intervention at time of study participation. * Documented HIV and/or MRSA positivity requiring treatment at time of study participation. * Seizure disorder not due to opioid withdrawal. * Invasive ventilation at time of study participation. * Recommendation of attending physician or primary medical caregiver not to enroll the patient for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Rate With and Without NEATCAP Intervention | 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. |
| Mean Respiratory Rate With and Without Intervention | 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. |
| Mean Heart Rate With and Without Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Movement Activity | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment in the neonatal and pediatric hospital units where infants receiving in-patient care.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Premature Infants (NICU) 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. | 10 |
| Experimental: Opioid-Exposed Newborns (NICU) 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. | 2 |
| Experimental: Hospitalized Infants (PICU) 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. | 4 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Developed infection prior to participation--excluded per protocol criteria | 0 | 0 | 1 |
| Overall Study | Discharged prior to participation | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental: Premature Infants (NICU) | Experimental: Opioid-Exposed Newborns (NICU) | Experimental: Hospitalized Infants (PICU) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | NA Participants | NA Participants | NA Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Mean Gestational Age (weeks) | 34.1 weeks STANDARD_DEVIATION 1.3 | NA weeks | NA weeks | NA weeks |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | NA Participants | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | NA Participants | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | NA Participants | NA Participants | NA Participants |
| Mean Post-Menstrual Age at time of 1st session | 35.84 weeks STANDARD_DEVIATION 1.2 | NA weeks | NA weeks | NA weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Asian | 0 Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) More than one race | 1 Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) White | 6 Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | 5 Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | 5 Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 10 | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 10 | 0 / 1 | 0 / 3 |
Outcome results
Primary
Mean Heart Rate With and Without Intervention
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.
Time frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premature Infants (NICU) | Mean Heart Rate With and Without Intervention | Heart Rate OFF1 | 149.8 beats/min | Standard Deviation 13.5 |
| Premature Infants (NICU) | Mean Heart Rate With and Without Intervention | Heart Rate ON | 151.8 beats/min | Standard Deviation 13.4 |
| Premature Infants (NICU) | Mean Heart Rate With and Without Intervention | Heart Rate OFF2 | 149.6 beats/min | Standard Deviation 12.9 |
Primary
Mean Respiratory Rate With and Without Intervention
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.
Time frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premature Infants (NICU) | Mean Respiratory Rate With and Without Intervention | Respiratory Rate OFF1 | 66.7 breaths/min | Standard Deviation 13.6 |
| Premature Infants (NICU) | Mean Respiratory Rate With and Without Intervention | Respiratory Rate ON | 62.6 breaths/min | Standard Deviation 8.2 |
| Premature Infants (NICU) | Mean Respiratory Rate With and Without Intervention | Respiratory Rate OFF2 | 64.9 breaths/min | Standard Deviation 10.9 |
Primary
Sleep Rate With and Without NEATCAP Intervention
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.
Time frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premature Infants (NICU) | Sleep Rate With and Without NEATCAP Intervention | NEATCAP OFF1 | 79.99 percent of period sleep | Standard Deviation 19.49 |
| Premature Infants (NICU) | Sleep Rate With and Without NEATCAP Intervention | NEATCAP ON | 94.11 percent of period sleep | Standard Deviation 9.07 |
| Premature Infants (NICU) | Sleep Rate With and Without NEATCAP Intervention | NEATCAP OFF2 | 75.74 percent of period sleep | Standard Deviation 25.46 |
p-value: 0.081Friedman's
p-value: 0.05Wilcoxon (Mann-Whitney)
p-value: 0.021Wilcoxon (Mann-Whitney)
Secondary
Mean Movement Activity
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.
Time frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premature Infants (NICU) | Mean Movement Activity | Percent Movement OFF1 | 26.4 percent | Standard Deviation 6.8 |
| Premature Infants (NICU) | Mean Movement Activity | Percent Movement ON | 26.9 percent | Standard Deviation 8.6 |
| Premature Infants (NICU) | Mean Movement Activity | Percent Movement OFF2 | 33.2 percent | Standard Deviation 7 |