An observational study in Respiratory Control in Premature Infants, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by Washington University School of Medicine · Observational
Among 85 studies in Apnea with a site in United States — 15 open to participants now, 18 under way, 2 of them phase 3. Apnea · United States.
Among the 85 studies in Apnea with a site in United States, this one is the 5th largest by enrollment of the 16 observational ones that give a count, is one of 7 that started in 2018, is one of 16 observational ones, and was the 60th registered.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
Browse Apnea studies →15 of the 85 studies in Apnea with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18+
University of Alabama at Birmingham · Sites in United States
Ages 22 wk–32 wk
Pfizer · Sites in United States
Ages 18+
University of Rochester · Sites in United States
Ages 0 days–27 wk
University of North Carolina, Chapel Hill · Sites in United States
Ages 8–13 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 40 Apnea studies recruiting now, 9 (23%) set no upper age limit and 27 (68%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 1 Day to 28 Days · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 3 · Phase 3 6 · Phase 4 8
First in 1999; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 177 is above the median of 60 across 78 observational studies indexed under Apnea.
Median enrollment 80 across the 69 interventional studies, 113 across the 16 observational. Of the 58 that completed or were terminated, 23 (40%) have results posted.
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18 of 85 have an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,804 studies on the registry; 270 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 4 studies filed under Apnea — fewer than ten, so there is no comparison to draw.
8 of the studies in Apnea with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06327152University of California, IrvineCaffeine Use in the Management of Preterm Infants | 2026-12 |
| NCT02431507Michael HarrisonMagnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety | 2026-12-01 |
| NCT07581938University of North Carolina, Chapel HillEarly Dental Risk Screening for Pediatric Sleep-Disordered Breathing | 2027-05 |
| NCT05527652University of MichiganSelf-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia | 2027-05 |
| NCT07570121Indiana UniversityPharmacokinetics and Placental Transfer of Caffeine | 2027-06 |
Add all 8 to your calendar (.ics) → With an account.
Among the 85 studies in Apnea with a site in United States, from their registry updates:
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The purpose of this research study is to improve our understanding of unstable breathing and heart blood flow patterns seen in premature infants. The investigator will use novel non-invasive measures to understand the determinants of these unstable breathing and heart flow patterns to potentially identify new therapies for their prevention.
The investigator will look at results of breathing tests, non-invasive sound wave (ultrasound) test of the heart and blood vessel (Echocardiography), and a sample of blood to see if it is possible for early detection of breathing control and lung blood vessel dysfunction (pulmonary vascular disease) in infants that are at risk for exposure to long term low oxygen levels. A subset of infants will have a magnetic resonance Imaging study (MRI) between 37- 40 weeks gestational age (GA) or at the time of discharge, whichever comes first.
Respiratory tests include:
Challenge Test completed at 36 weeks GA.
A subset of infants will have an MRI between 37-40 weeks GA or before discharge, whichever comes first. The MRI will allow the doctors to look and see if there is any injury present in the brain that can be linked to an abnormal breathing pattern called periodic breathing.
A subset of infants will have an Echocardiogram (Echo) at 32, 36 and 52 weeks GA. The Echo is performed to assess cardiac structure and function. Echocardiography is performed routinely in premature newborns in the Neonatal Intensive Care Unit (NICU). The echocardiogram will be performed at the infant bedside and will be coordinated with bedside nurse. The infant will remain on a cardio-respiratory monitor during the echocardiogram for approximately 15 minutes.
Infants that have an Echo will have a blood sample collected near the time of the Echo, 3-blood samples total. The purpose of collecting the blood sample is to detect if the Fibroblast Growth Factor (FGF2) level is elevated and possibly be a biomarker of early pulmonary hypertension in pre term infants validated with the echo.
Infants admitted to the Neonatal Intensive Care Unit who are born between 24 0/7 to 28 7/8 weeks GA
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Preterm infants Study Visits 1. Bedside Physiology Study at 28, 32, 36, 40, and 52 weeks GA. 2. Respiratory tests: * Carotid Body Function Test will be completed at 32, 36, 40 and 52 weeks GA * Room Air Challenge (RAC) or Hypoxia Challenge Test (HCT) will be completed at 36 weeks GA * Effects of nasal cannula flow be completed at 28, 32, 36, 40 and 52 weeks GA 3. Magnetic Resonance Imaging (MRI): Completed on a subset of infants between 37-40 weeks GA or before discharge, whichever comes first. 4. Echocardiogram (Echo): Completed at 32, 36 and 52 weeks GA 5. Blood sample: Obtained at 32, 36 and 52 weeks GA
Other: Bedside Physiology study · Other: Carotid Body Function Test · Other: Room Air Challenge · Other: Hypoxia Challenge Test · Other: Effects of Nasal Cannula Flow · Diagnostic Test: Magnetic Resonance Imaging · Diagnostic Test: Echocardiogram · Other: Blood Sample
A 90-minute recording in conjunction with the respiratory evaluations using standard recording equipment that includes a conventional pulse oximeter, an EEG, an airflow sampling catheter near the nose, and respiratory inductance plethysmography (RIP) bands. Standard clinical bedside monitoring will continue during the respiratory evaluations.
Infants without nasal cannula will have a nasal cannula placed in their nares. After a 15-minute baseline period and during quiet sleep, the infant will then be exposed to 30 seconds of 100% oxygen (O2) by increasing FiO2. This test will be repeated 3 times, with at least 3 minutes between tests to allow for return of oxygen saturation (SpO2) to baseline values. If oxygen saturations increase to 99% for 15 seconds or the infant is apneic for greater than 5 seconds following initiation of 100% oxygen (O2), the test will be stopped and FiO2 brought back to baseline. Infants in the NICU will be monitored continuously with heart rate, respiratory rate, and SpO2% for 12 hours after Carotid Body Function Test according to NICU standards. Infants discharge who return for Carotid Body Function Test at 40 and 52 weeks PMA will be monitored continuously for 1 hour after the test is finished.
Infants receiving nasal cannula high flow support 3 liters per minute (LPM) or less with or without supplemental O2 at 36 weeks PMA will be eligible. After a 15-minute quiet sleep period, infants' FiO2 will be weaned, in 0.20 decrements for 5 min intervals. Flow then decreased in 10 min intervals, initially in 1 Liter Per Minute (LPM) decrement until nasal cannula flow is 1LPM, and then decreased by 50% decrements to 0.125 LPM then off. If the infant is weaned to room air alone for 15 minutes, not meeting failure criteria, he/she has passed the RAC. Failure of the RAC is defined as occurring when SpO2% falls below 80%, even briefly, or remains less than 90% for 5 consecutive minutes any time during the test, bradycardia (Heart rate \[HR\] \< 80 bpmx 10 sec) or persistent apnea despite stimulation. Infant is returned to the level of support provided before the RAC begun if meets any failure criteria.
Also known as: RAC
A physician investigator will review 30 minutes of continuous recording made 24 hours prior to test scheduled to identify infants that are at high risk for significant oxygen desaturations during Hypoxemia Challenge. If subject passes the screening test, the hypoxic challenge will be performed. For the hypoxemia test, a nasal cannula will be placed prior to a 15 minute period of quiet sleep recorded to confirm antecedent stability of ventilatory pattern and SpO2%. During the 15 minutes of quiet sleep, the infant is required to maintain a SpO2 of \> 92% in order to undergo the HCT. After the 15-minute baseline recording, HCT will begin using FiO2 = 0.18 for 5 minutes, unless failure criteria is met: SpO2% \< 80% even briefly, or SpO2% 80% to 85% for 15 seconds. If infant does not meet failure criteria, infant will be given FiO2 0.15 for 10 minutes. If an infant meets even a single criterion for failure, Hypoxic mixture will be stopped.
Also known as: HCT
Infants will have nasal catheter in place (NeoTech Premature RAM Cannula). A 15-minute baseline recording of physiologic study parameters prior to initiation. Tested in three groups of infants. 1. 28 and 32 weeks PMA flow rates increased after a 15-minute baseline period to 3LPM, or by 1LPM to a max of 5LPM for 15 minutes. Infant on Bubble CPAP will be increased 1cm H2O to max 8 cm H2O for 15 minutes. 2. Infant's that fail the RAC or HCT at 36 weeks with periodic breathing, high flow at 3LPM will be started for 2 minutes or until periodic breathing stops. Infants on Bubble CPAP will not undergo the RAC or HCT. Their pressure is increased by 1cm H20 to max of 8 cm H2O for 15 minutes. 3. Infant on RA at 40 and 52 weeks PMA with periodic breathing lasting longer than 1 minute during the 15-minute baseline period, flow at 3LPM will be started for 2 minutes or until periodic breathing stops.
A non-sedating MRI scan will be performed on 3 subsets of infants at 37-40 weeks Post Menstrual Age (PMA), or when infant is within one week of discharge from the NICU. Standard images as well as research images will be obtained. The research images use the same MRI scanner and collection techniques as standard clinical imaging, but provide a more detailed examination of brain anatomy and injury. Collection of these sequences using our standard non-sedated acquisition practices for infants is well tolerated. Infants will be placed in scanner by registered nurse accompanied by radiology technician to assure infants' comfort during scan. Infant will remain on cardio-respiratory monitor during MRI via a pulse oximetry probe. It will take no longer than one hour to complete MRI scan including transportation to radiology unit.
Also known as: MRI
An echocardiogram (referred to as an ultrasound of the heart on the consent form) will be performed to assess cardiac structure and function. Echocardiograms are performed routinely in premature newborns in the NICU. The Echocardiogram will be performed at the infant bedside and will be coordinated with bedside nurse. The infant will remain on a cardio-respiratory monitor during the echocardiogram for approximately 15 minutes.
Also known as: Echo
Infants that have echocardiograms will have a blood sample collected near the time the echocardiogram is obtained, 3-blood samples total. The blood sample will only be collected with parental permission on an opt-in or out-basis and collected only with routine clinical labs.
Respiratory phenotype based on physiologic testing
Categorization of subjects based on physiologic Challenge Tests into one of four respiratory phenotypes.
Time frame: 36 weeks post menstrual age
Plan to share: No
Ran from May 2018 to primary completion in Feb 2022, 44 months.
Of 35 observational studies under Apnea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 38. This study's 44 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine →