NCT01537354

Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome

A Comparison of Immediate Changes in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 15 Minutes – 12 Hours
• Healthy volunteers: Not accepted

Summary

This is a null hypothesis study. The investigators hypothesize that there will be no difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute intervals after administration of either surfactant and there will be no differences in the number of doses needed between the two surfactants in premature infants admitted to our NICU.

Detailed description

Premature newborn infants may have impaired lung function as a result of their prematurity. When this occurs, the newborns show poor oxygen and carbon dioxide exchange and difficulty in breathing. The reason for these symptoms is due in part to the lack of special chemicals in the lungs, called phospholipids or surfactant. The lack of these special chemicals causes the babies lung to be difficult to ventilate. Treatment of this condition can require placing an artificial airway (endotracheal tube) into the babies windpipe (intubation) and use of a breathing machine (ventilator). In addition, physicians frequently give these special chemicals (phospholipid) through the childs airway. There are several different types of phospholipids available for this treatment in newborns but very limited amount of studies have been done to examine differences in the ability to ventilate between the various types of surfactant. The investigators propose to examine immediate changes in ability to ventilate (dynamic compliance) at specific time intervals after administration of either type of surfactant; Curosurf or Survanta.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Curosurf®	Initial dose is 2.5ml/kg (200 mg/kg phospholipid) administered via endotracheal tube. Subsequent doses if needed are 1.25 mL/kg (100 mg/kg phospholipids).
DRUG	Survanta®	Initial dose is 4 mL/kg (100 mg/kg phospholipids) administered via endotracheal tube. Subsequent doses if needed are 4 mL/kg (100 mg/kg phospholipids).

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-12-01
• First posted: 2012-02-23
• Last updated: 2014-01-08

Locations

1 site across 1 country: United States