Respiratory Distress Syndrome in Premature Infant Clinical Trial
Official title:
Comparison of Two Nasal Interface for Continuous Distending Airway Pressure in Preterm Infants: RAM Nasal Cannula and Hudson Prongs
NCT number | NCT03212508 |
Other study ID # | STUDY00029410 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2016 |
Est. completion date | March 22, 2017 |
Verified date | July 2023 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Continuous distending airway pressure (CPAP) has gained popularity as a means to provide non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI). However, maintaining CPAP in preterm infants has been challenging, often related to issues with nasal interface such as nasal septal injury, problems with keeping the prongs in the nose and leak around the prongs with are important factors in proving effective CPAP. RAM cannula was recently approved for providing supplemental oxygen and soon adapted by many centers to provide CPAP in preterm infants. Concerns have been raised that RAM cannula interface results in sub-optimal pressure delivery compared to standard nasal prongs.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 22, 2017 |
Est. primary completion date | March 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 48 Hours to 52 Weeks |
Eligibility | Inclusion Criteria: - Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV will be eligible for the study. We will recruit preterm infant more than 48 hours old and stable on bubble CPAP Exclusion Criteria: - Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference between set pressure and measured pressure with RAM cannula and Hudson prong | Intraoral pressure measure using a differential pressure transducer with RAM cannula and then with Hudson prongs | one hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04016246 -
Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.
|
Phase 3 | |
Enrolling by invitation |
NCT04118400 -
Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates
|
||
Completed |
NCT01941745 -
Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
|
Phase 2 | |
Not yet recruiting |
NCT04019106 -
Budesonide With Intratracheal Surfactants in Extremely Preterm Infants
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04862377 -
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.
|
Phase 3 | |
Not yet recruiting |
NCT05791331 -
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
|
N/A | |
Completed |
NCT04086095 -
Feasibility Study - Neofact
|
N/A | |
Not yet recruiting |
NCT05609877 -
The NONA-LISA Trial
|
N/A | |
Recruiting |
NCT04326270 -
Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
|
N/A | |
Active, not recruiting |
NCT03969992 -
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
|
Phase 2 | |
Completed |
NCT03700606 -
Physiological Changes With High-Flow Nasal Cannula
|
N/A | |
Recruiting |
NCT04359134 -
Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.
|
||
Not yet recruiting |
NCT06229821 -
Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants
|
N/A | |
Recruiting |
NCT05446389 -
PAL to Improve Oral Feeding for Infants With Chronic Lung Disease
|
N/A | |
Withdrawn |
NCT04914715 -
nHFOV Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome
|
N/A | |
Recruiting |
NCT03825835 -
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
|
N/A | |
Recruiting |
NCT03562182 -
Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
|
||
Completed |
NCT05031650 -
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
|
N/A | |
Completed |
NCT03306524 -
The Role of Circuit Flow During Mechanical Ventilation of Neonates
|
N/A | |
Completed |
NCT01473264 -
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
|
Phase 1/Phase 2 |