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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство Effective oxygen delivery and lung expansion measurement
  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.

Первичные конечные точки

• Inspired Oxygen [Срок оценки: Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.]

Вторичные конечные точки (1)

• Lung Volume [Срок оценки: Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• University of Arkansas for Medical Sciences — Little Rock
• University of Arkansas for Medical Sciences — Little Rock

Публикации

• 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
• 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
• 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
• 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
• 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 PMID 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. PMID 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. PMID 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. PMID 34162692

Идентификаторы

NCT: NCT07674953 · 299138

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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