Interventions to Help Infants Recover in the Hospital

Stopped early · Not applicable

Conditions studied: Infant Apnea, Neonatal Abstinence Syndrome, Sleep

In brief

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.

Key facts

Study ID

NCT03881553

Run by

Elisabeth Salisbury, PhD

People needed

17

Starts

2019-07-19

Expected to finish

2020-12-31

Last updated by the study team

2022-06-01

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UMass Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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