Clinical Trials Logo

Clinical Trial Summary

Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.

The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.


Clinical Trial Description

30 infants were randomized to receive either poractant or calfactant for Respiratory Distress Syndrome.

Tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02834624
Study type Interventional
Source University of Missouri-Columbia
Contact
Status Completed
Phase N/A
Start date July 2013
Completion date July 2015

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