Interventions to Help Infants Recover in the Hospital
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any - 5 |
| Updated: | 3/21/2019 |
| Start Date: | March 2019 |
| End Date: | July 2021 |
| Contact: | Elisabeth Salisbury, PhD |
| Email: | elisabeth.salisbury@umassmed.edu |
| Phone: | 508-334-8627 |
Interventions to Help Infants and Children Recover in the Hospital
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.
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.
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) Critically-ill 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.
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) Critically-ill 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.
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.
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