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CPAP Delivery Systems for Neonatal Respiratory Distress Syndrome

Q: What is the primary aim of this research endeavor?

This trial will last for 2.5 hours as investigators measure the efficacy of CPAP treatment. Secondary outcomes comprise clinical results of different CPAP modalities, frequency of exogenous surfactant administration (as a percentage), lung physiology measurements such as pressure rate product (cm H2O / min) and end expiratory pressure via esophageal balloon manometry (mm Hg). These metrics form an exploratory pilot study in preparation for a more comprehensive larger trial.

Q: Who is eligible to participate in this clinical experiment?

Candidates hoping to join this clinical trial must attest that they have respiratory distress syndrome and fall between the ages of 12 Hours and 36 hours. The study is looking for approximately 20 participants in total.

Q: Does this medical experiment accept participants who are senior citizens?

This research is looking for participants aged 12 to 36 years old.

Q: Are new participants accepted for this research project?

Per clinicaltrials.gov, this medical experiment is currently enrolling individuals. The trial was initially posted on October 18th 2023 and has since undergone its most recent update one day prior.

Q: What is the expected cohort size for this medical trial?

Affirmative. As seen on clinicaltrials.gov, this medical experiment is still actively enrolling patients with the initial posting date being October 18th 2023 and its most recent amendment occurring two days prior to that. Currently, they are recruiting for a total of twenty participants from one particular centre.

N/A

Recruiting

Led By Jessica E Shui, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medically stable neonates born >32 0/7 weeks and < 37 0/7 weeks gestational age, with birth weights > 1500 grams, chronologically 12-36 hours old, and receiving RAM cannula ventilator CPAP with PEEP between 5-6 cm H2O and FiO2 < 0.3 for the suspected diagnosis of respiratory distress syndrome

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 hours during the lung physiology assessment

Awards & highlights

Study Summary

This trial seeks to compare CPAP devices for newborns with respiratory distress, to find which works best and how to shorten recovery time.

Who is the study for?

This trial is for stable newborns born between 32 and less than 37 weeks of gestation, weighing over 1500 grams, aged 12-36 hours, suspected to have respiratory distress syndrome and already on CPAP treatment. Newborns with certain conditions affecting the lungs or skin, or those who can't have an esophageal balloon placed are excluded.Check my eligibility

What is being tested?

The study compares two types of CPAP devices in late preterm infants with breathing difficulties: RAM cannula ventilator CPAP versus Occlusive interface bubble CPAP. It aims to determine which device offers better support and predicts shorter treatment duration using lung physiology data.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing a chest belt or having an esophageal balloon manometry. There might also be risks associated with switching between different CPAP devices that will be monitored by healthcare professionals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn is stable, was born slightly early, weighs over 1500 grams, is 12-36 hours old, and needs mild breathing support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 hours during the lung physiology assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 hours during the lung physiology assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 hours during the lung physiology assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in electrical impedance

duration of CPAP treatment

Secondary outcome measures

clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)

clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation

clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"Experimental Treatment1 Intervention

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

Group II: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"Experimental Treatment1 Intervention

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

Group III: Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"Active Control1 Intervention

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

Group IV: Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"Active Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,621 Total Patients Enrolled

16 Trials studying Respiratory Distress Syndrome

9,323 Patients Enrolled for Respiratory Distress Syndrome

Jessica E Shui, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary aim of this research endeavor?

"This trial will last for 2.5 hours as investigators measure the efficacy of CPAP treatment. Secondary outcomes comprise clinical results of different CPAP modalities, frequency of exogenous surfactant administration (as a percentage), lung physiology measurements such as pressure rate product (cm H2O / min) and end expiratory pressure via esophageal balloon manometry (mm Hg). These metrics form an exploratory pilot study in preparation for a more comprehensive larger trial."

Answered by AI

Who is eligible to participate in this clinical experiment?

"Candidates hoping to join this clinical trial must attest that they have respiratory distress syndrome and fall between the ages of 12 Hours and 36 hours. The study is looking for approximately 20 participants in total."

Answered by AI

Does this medical experiment accept participants who are senior citizens?

"This research is looking for participants aged 12 to 36 years old."

Answered by AI

Are new participants accepted for this research project?

"Per clinicaltrials.gov, this medical experiment is currently enrolling individuals. The trial was initially posted on October 18th 2023 and has since undergone its most recent update one day prior."

Answered by AI

What is the expected cohort size for this medical trial?

"Affirmative. As seen on clinicaltrials.gov, this medical experiment is still actively enrolling patients with the initial posting date being October 18th 2023 and its most recent amendment occurring two days prior to that. Currently, they are recruiting for a total of twenty participants from one particular centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

Jessica E Shui, MD 2023. "Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038565.

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