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

NCT07674953 | Recruiting FDA Device

• 1 other identifier: 299138
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Respiratory Distress Syndrome (Neonatal); Respiratory Distress of Newborn

Keywords

respiratory distress syndrome; CPAP; preterm infant; effective oxygen delivery

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Lung Volume

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

Study Arms (1)

Infants on nCPAP

EXPERIMENTAL

All 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.

Device: Effective oxygen delivery and lung expansion measurement

Interventions

Effective oxygen delivery and lung expansion measurement DEVICE

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.

Also known as: EIT

Infants on nCPAP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

NOT YET RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 33246967 BACKGROUND

• 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.

  PMID: 10654946 BACKGROUND

• 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.

  PMID: 32762014 BACKGROUND

• 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.

  PMID: 26948884 BACKGROUND

• 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.

  PMID: 27596161 BACKGROUND

• 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.

  PMID: 34830385 BACKGROUND

• 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.

  PMID: 28545875 BACKGROUND

• 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.

  PMID: 34162692 BACKGROUND

• 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.

  PMID: 8130865 BACKGROUND

• 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.

  PMID: 19491438 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Nicholas A Rowley, MD

CONTACT

940-230-5002; NARowley@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning once data collection is complete and for three months afterward to afford time for statistical analysis.
• Access Criteria: Only primary investigators will be able to access de-coded IPD. One single collaborator will have access to coded IPD for the purpose of statistical analysis.

Locations

US (2)