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

Not Applicable

Withdrawn

• Conditions: Respiratory Distress Syndrome
• Interventions: Drug: Survanta®; Drug: Curosurf®

• Registration Number: NCT01537354
• Lead Sponsor: University of Michigan

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-23
• Study Start: 2012-06
• Primary Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Preterm infants between 28 and 31 6/7 weeks' gestational age
• Inborn to UM NICU
• < 12 hours of age
• Respiratory Distress Syndrome
• radiographic evidence
• need for endotracheal intubation
• Oxygen requirement > 30% FiO2
• Decision to give surfactant by the treatment team

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Exclusion Criteria

• Major congenital anomaly
• Sepsis syndrome in extremis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Survanta®	Survanta®	Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.
Curosurf®	Curosurf®	Curosurf® (Cornerstone Therapeutics, Inc., Cary, NC Surfactant will be administered by respiratory therapist not involved in patient's care.

Primary Outcome Measures

Name	Time	Method
Change in dynamic compliance	15 minutes, 30 minutes, 45 minutes and then hourly intervals after administration of surfactant. Subjects' compliance will be monitored hourly after the first 60 minutes while they are being ventilated in the Neonatal Intensive Care Unit.	Patient's dynamic compliance will be measured immediately after initial dosage, q15 minutes for 60 minutes and hourly for 48 hrs as long as intubated.

Trial Locations

Locations (1)

University of Michigan C & W Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States