An interventional study of Nasal interface in Respiratory Distress Syndrome in Premature Infant, sponsored by Arkansas Children's Hospital Research Institute. Status unknown at 1 site in United States. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Treatment
Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.
Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).
Arkansas Children's Hospital Research Institute is the lead sponsor of 122 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Device: Nasal interface
Device: Nasal interface
Randomized to initial interface of nCPAP prongs or infant cannula
Also known as: Neotech RAM infant cannula, Miniflow Nasal CPAP Prongs
Relative tidal volume delivery, breath type I
Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths
Time frame: 1 hour
Relative tidal volume delivery, breath type II
Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths
Time frame: 1 hour
Relative tidal volume delivery, breath type III
Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths
Time frame: 1 hour
Ventilator pressure delivery
Time frame: 1 hour
Ventilator flow delivery
Time frame: 1 hour
Heart rate
Time frame: 1 hour
Oxygen saturation
Time frame: 1 hour
Transcutaneous carbon dioxide tension
Time frame: 1 hour
Transcutaneous oxygen tension
Time frame: 1 hour
Plan to share: Undecided
Started Mar 2019 (actual). Primary completion is estimated for Jun 2020, 15 months after the start.
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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