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Completed

NCT Number: NCT03081611

RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants

Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature Infant, Premature, Diseases Intubation, Intratracheal Lung Diseases Noninvasive Ventilation Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Medical Center

Haifa, 31096, Israel

About this study

Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age 24-33.6
  • Physician decision on the need for non invasive ventilation
  • parental consent

Exclusion criteria

  • Pneumothorax before recruitment
  • Significant congenital heart disease or chromosomal disorder

Treatment and study plan

Ram cannula

Device

Ventilatory support for preterm infants using Ram cannula

Short nasal prongs

Device

Ventilatory support for preterm infants using short nasal prongs

Primary outcomes

  1. intubation

    Time frame: 72 hours

    The need for intubation

Secondary outcomes

  1. nasal trauma

    Time frame: during NIPPV procedure

    nasal trauma

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial

Acronym: RAMCAN

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 16, 2017
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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