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Respiratory Distress Syndrome (Neonatal)NCT07674953

How Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants

A study testing Effective oxygen delivery and lung expansion measurement in people with Respiratory Distress Syndrome (Neonatal) and Respiratory Distress of Newborn, run by University of Arkansas at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine. Read more about this study

Who is it for?
Any age
What is being tested?
Effective oxygen delivery and lung expansion measurement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
15 Apr 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical
  • The infant must be stable while receiving nasal CPAP at any pressure level at the time of study
  • The infant must be receiving 22-40% at the time of the study

Who cannot join

  • Oxygen requirements greater than 40% at time of enrollment
  • currently receiving invasive ventilation or not requiring ventilatory support
  • Major congenital anomalies of the heart and/or lungs

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicholas A Rowley, MD contact

940-230-5002

NARowley@uams.edu

United States2 sites, 2 recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Nicholas A Rowley, MD, 940-230-5002, NARowley@uams.edu

    Not yet recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Sherry Courtney Research Mentor, MD, 501-526-1500, SECourtney@uams.edu

    Nicholas Rowley, MD

    Recruiting

Other trials in United States

About this study

Official title: Oxygen Delivery in CPAP and Its Relationship With Regional Lung Ventilation in Preterm Infants

With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine.

Read the detailed description

This study will tell more about a specific method of breathing support used frequently with preterm babies called nasal continuous positive airway pressure (nCPAP). It helps the baby breathe by providing air pressure and a certain amount of oxygen. It is very important for the baby's health to provide only as much oxygen as they need.

With this study, it is expected to learn if the amount of oxygen ordered by a doctor on the nCPAP machine changes when it reaches the baby's airway, and if the amount of oxygen changes depending on how much air pressure the doctor provides. The answers to these questions, are not known, because special measurements are required that are difficult to know while a baby is on nCPAP. This study will collect these special measurements

Being tested
Effective oxygen delivery and lung expansion measurement
Keywords
respiratory distress syndrome, CPAP, preterm infant, effective oxygen delivery
Medical subject headings
Pulmonary Atelectasis, Respiratory Distress Syndrome, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Effective oxygen delivery and lung expansion measurementDevice

    Also called EIT

    This intervention arm will involve any infant who is already on nCPAP. It will involve placing a catheter in the infant's oropharynx and wrapping soft EIT bands around the infants chest to measure effective oxygen delivery and lung expansion, respectively.

Study groups in NCT07674953
Study groupRoleWhat they receive
Infants on nCPAPExperimentalAll infants on CPAP will have a catheter placed in their oropharynx to measure delivered oxygen and a soft band placed around the infant's chest to measure lung expansion.
Receives: Device: Effective oxygen delivery and lung expansion measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inspired Oxygen

    Percent of oxygen delivered to the back of the infant's mouth. This will be measured by placing a small plastic tube in the back of the infant's mouth and sampling the air while the infant is receiving several different pressure levels of CPAP.

    Measured: Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.

Secondary outcomes (1)

  1. Lung Volume

    Using Electrical Impedance Tomography bands, the infant's lung volume will be monitored at several different CPAP pressure levels. These bands wrap around the infant's chest and measure lung volume using mild electrical currents.

    Measured: Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start15 Apr 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07674953
Sponsor's protocol ID
299138
Status last verified
Jun 2026
First submitted
23 Jun 2026
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Coded IPD will be shared with a collaborator once data collection is complete for the purpose of statistical analysis. All shared IPD will be de-identified and individual patients will be given an identifying code. Shared information will include gestational age, date of birth, postnatal age, race/ethnicity, vital signs, prior medical history, current respiratory support, complications during pregnancy, medical problems and diagnoses that the infant receives during hospitalization, and the inspired oxygen and lung volume values gathered during the study itself.

Publications

  • Thomson J, Ruegger CM, Perkins EJ, Pereira-Fantini PM, Farrell O, Owen LS, Tingay DG. Regional ventilation characteristics during non-invasive respiratory support in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):370-375. doi: 10.1136/archdischild-2020-320449. Epub 2020 Nov 27.

    PubMed 33246967

  • Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542/peds.105.2.295.

    PubMed 10654946

  • Ramaswamy VV, More K, Roehr CC, Bandiya P, Nangia S. Efficacy of noninvasive respiratory support modes for primary respiratory support in preterm neonates with respiratory distress syndrome: Systematic review and network meta-analysis. Pediatr Pulmonol. 2020 Nov;55(11):2940-2963. doi: 10.1002/ppul.25011. Epub 2020 Sep 4.

    PubMed 32762014

  • Gupta S, Donn SM. Continuous positive airway pressure: Physiology and comparison of devices. Semin Fetal Neonatal Med. 2016 Jun;21(3):204-11. doi: 10.1016/j.siny.2016.02.009. Epub 2016 Mar 3.

    PubMed 26948884

  • Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

    PubMed 27596161

  • Cannavo L, Perrone S, Viola V, Marseglia L, Di Rosa G, Gitto E. Oxidative Stress and Respiratory Diseases in Preterm Newborns. Int J Mol Sci. 2021 Nov 19;22(22):12504. doi: 10.3390/ijms222212504.

    PubMed 34830385

  • Bhatia R, Davis PG, Tingay DG. Regional Volume Characteristics of the Preterm Infant Receiving First Intention Continuous Positive Airway Pressure. J Pediatr. 2017 Aug;187:80-88.e2. doi: 10.1016/j.jpeds.2017.04.046. Epub 2017 May 22.

    PubMed 28545875

  • Bhatia R, Carlisle HR, Armstrong RK, Kamlin COF, Davis PG, Tingay DG. Extubation generates lung volume inhomogeneity in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):82-86. doi: 10.1136/archdischild-2021-321788. Epub 2021 Jun 23.

    PubMed 34162692

  • Benaron DA, Benitz WE. Maximizing the stability of oxygen delivered via nasal cannula. Arch Pediatr Adolesc Med. 1994 Mar;148(3):294-300. doi: 10.1001/archpedi.1994.02170030064015.

    PubMed 8130865

  • Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2.

    PubMed 19491438

Questions about this trial

What is this clinical trial studying?

A study testing Effective oxygen delivery and lung expansion measurement in people with Respiratory Distress Syndrome (Neonatal) and Respiratory Distress of Newborn, run by University of Arkansas at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicholas A Rowley, MD (940-230-5002, NARowley@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspired Oxygen (time frame: Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07674953, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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