Comparison of Two Nasal Interface for CPAP in Preterm

NCT03212508 | Completed FDA Device

• 1 other identifier: STUDY00029410
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

Continuous positive airway pressure, preterm

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

RAM cannula and Hudson prongs DEVICE

Measuring intraoral pressure using two different nasal interface for applying nasal continuous positive airway pressure

Eligibility Criteria

• Age: 48 Hours - 52 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Any preterm with respiratory distress requiring CPAP

You may qualify if:

• 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

You may not qualify if:

• Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Related Publications (1)

• Singh N, McNally MJ, Darnall RA. Does the RAM Cannula Provide Continuous Positive Airway Pressure as Effectively as the Hudson Prongs in Preterm Neonates? Am J Perinatol. 2019 Jul;36(8):849-854. doi: 10.1055/s-0038-1675330. Epub 2018 Nov 5.

  PMID: 30396227 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: August 1, 2016
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share