Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

NCT06038565 | Withdrawn

• 1 other identifier: 2023P001796
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare late preterm newborn lung physiology when supported with different continuous positive airway pressure (CPAP) devices. The main questions it aims to answer are:

• Which CPAP modality provides better breathing support in newborns with respiratory distress syndrome who are greater than 32 weeks gestational age?
• Does the lung physiology data predict the CPAP modality that will result in a shorter CPAP treatment duration? Participants will wear a belt of electrodes on their chest (electrical impedance tomography) and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while switching CPAP devices. Participants will then be randomly assigned to a CPAP device to support their breathing until they recover from respiratory distress syndrome.

Conditions

Prematurity; Respiratory Distress Syndrome

Keywords

continuous positive airway pressure

Outcome Measures

Primary Outcomes (2)

• change in electrical impedance

  change in average electrical impedance with each CPAP delivery modality

  2.5 hours during the lung physiology assessment

• duration of CPAP treatment

  compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2

  through study completion, an average of 2 weeks after the lung physiology assessment

Secondary Outcomes (14)

• lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance

  2.5 hours during the lung physiology assessment

• lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility

  2.5 hours during the lung physiology assessment

• lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume

  2.5 hours during the lung physiology assessment

• lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation

  2.5 hours during the lung physiology assessment

• lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance

  2.5 hours during the lung physiology assessment

Study Arms (4)

Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"

EXPERIMENTAL

After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar). In this Arm A-1, these subjects had higher change in impedance while supported on RAM cannula ventilator CPAP

Device: RAM cannula ventilator CPAP

Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"

EXPERIMENTAL

After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar). In this Arm A-2, these subjects had higher change in impedance while supported on occlusive mask bubble CPAP

Device: Occlusive interface bubble CPAP

Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"

ACTIVE COMPARATOR

Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the Neonatal Intensive Care Unit (NICU) where the newborn is hospitalized. In this Arm B-1, these subjects are randomized 1:1 to RAM cannula ventilator CPAP

Device: RAM cannula ventilator CPAP

Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"

ACTIVE COMPARATOR

Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the NICU where the newborn is hospitalized. In this Arm B-2, these subjects are randomized 1:1 to occlusive mask bubble CPAP

Device: Occlusive interface bubble CPAP

Interventions

RAM cannula ventilator CPAP DEVICE

RAM cannula ventilator CPAP

Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"; Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"

Occlusive interface bubble CPAP DEVICE

Occlusive interface bubble CPAP

Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"; Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"

Eligibility Criteria

• Age: 12 Hours - 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• medically stable neonates born \>32 0/7 weeks and \< 37 0/7 weeks gestational age, with birth weights \> 1500 grams, are chronologically 12-36 hours old, and are receiving RAM cannula ventilator CPAP with positive end expiratory pressure (PEEP) between 5-6 cm water (H2O) and Fraction of inspired oxygen (FiO2) \< 0.3 for the suspected diagnosis of respiratory distress syndrome

You may not qualify if:

• neonates with congenital anomalies that potentially will affect respiratory physiology, for example hypoplastic lungs or gastroschisis.
• neonates with contraindications for wearing an occlusive interface, for example epidermolysis bullosa which may have risk of worsening skin integrity at the pressure points of the occlusive interface, or a known small air leak that may potentially develop into a large pneumothorax.
• neonates with contraindications for placement of esophageal balloon manometry, for example hypoglycemia managed with extended feeding times greater than 30 minutes.
• neonates with contraindications for electrical impedance tomography, for example inability to ensure contact of the electrodes on the belt with the skin on the circumference of the chest due to presence of a chest tube dressing.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

• Prakash R, De Paoli AG, Davis PG, Oddie SJ, McGuire W. Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD015130. doi: 10.1002/14651858.CD015130.

  PMID: 37009665 BACKGROUND

• Prakash R, De Paoli AG, Oddie SJ, Davis PG, McGuire W. Masks versus prongs as interfaces for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD015129. doi: 10.1002/14651858.CD015129.

  PMID: 36374241 BACKGROUND

• Green EA, Dawson JA, Davis PG, De Paoli AG, Roberts CT. Assessment of resistance of nasal continuous positive airway pressure interfaces. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F535-F539. doi: 10.1136/archdischild-2018-315838. Epub 2018 Dec 19.

  PMID: 30567774 BACKGROUND

• Courtney SE, Pyon KH, Saslow JG, Arnold GK, Pandit PB, Habib RH. Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics. 2001 Feb;107(2):304-8. doi: 10.1542/peds.107.2.304.

  PMID: 11158463 BACKGROUND

• Nascimento MS, do Prado C, Costa ELV, Alcala GC, Correa LC, Rossi FS, Amato MBP, Rebello CM. Effect of flow rate on the end-expiratory lung volume in infants with bronchiolitis using high-flow nasal cannula evaluated through electrical impedance tomography. Pediatr Pulmonol. 2022 Nov;57(11):2681-2687. doi: 10.1002/ppul.26082. Epub 2022 Aug 17.

  PMID: 35931651 BACKGROUND

• Seddon PC, Davis GM. Validity of esophageal pressure measurements with positive end-expiratory pressure in preterm infants. Pediatr Pulmonol. 2003 Sep;36(3):216-22. doi: 10.1002/ppul.10284.

  PMID: 12910583 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

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica E Shui, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Given the nature of CPAP, it is not possible to mask which CPAP device the subject is supported by, but the participant, care provider, and outcomes assessor will be masked to whether the subject was randomized to arm A (the device the lung physiology assessment deemed superior for that subject) or arm B (random assignment to the CPAP device, not taking into account the subject's lung physiology).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist, Assistant Professor of Pediatrics at MGH

Model Details: Lung physiology measurements with electrical impedance tomography and esophageal manometry will be collected while the participant is supported with RAM cannula ventilator CPAP followed by occlusive interface ventilator CPAP followed by occlusive interface bubble CPAP. A 1:1 block randomization of either A) physiology-based CPAP or B) one size fits all CPAP of either RAM cannula ventilator CPAP or occlusive interface bubble CPAP will be assigned to the participant. Arm B is further randomized 1:1 to either RAM cannula ventilator CPAP or occlusive interface bubble CPAP. The duration of CPAP treatment will be compared between the two arms (precision medicine approach vs standard of care) as well as compare each device and whether the physiology data would have predicted the CPAP device would have resulted in a shorter treatment period.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 15, 2023
• Study Start: October 18, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)