Clinical Trials Logo

Clinical Trial Summary

There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP may be beneficial. On the other hand, removing CPAP too early may lead to complications that include: increasing apnea, increased oxygen requirement, increased work of breathing, the need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental study have demonstrated an improvement in lung growth after the prolonged use of CPAP.

Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of preterm infants. The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.

The purpose of this randomized controlled trial is to evaluate the clinical impact of two methods for weaning preterm infants from nCPAP.


Clinical Trial Description

The objective of this study is to test the null hypothesis that in preterm infants with gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen concentrations (FiO2) <0.30, keeping these infants on CPAP or changing them to NC flow of 1-2 L/min will not make any difference in length of hospitalization, length of respiratory support and incidence of complications. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01093495
Study type Interventional
Source Mansoura University
Contact
Status Completed
Phase N/A
Start date January 2009
Completion date January 2010

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06168149 - The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Suspended NCT01852916 - NHFOV Versus NCPAP to Prevent Exubation Failure N/A
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Recruiting NCT03510169 - Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe N/A
Completed NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT03292562 - A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation N/A
Completed NCT05948332 - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Completed NCT05038514 - The Effect of Music Therapy in COVID-19 Patients Given Prone Position N/A
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT05462509 - Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda N/A
Active, not recruiting NCT03808402 - The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
Completed NCT01812681 - Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities N/A
Completed NCT01517958 - Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates N/A
Not yet recruiting NCT01440868 - Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome N/A
Completed NCT01222247 - Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Phase 3