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

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.

Study Overview

• Status: Withdrawn
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Survanta®; Drug: Curosurf®

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0245
      • University of Michigan C & W Mott Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 minutes to 12 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• Major congenital anomaly
• Sepsis syndrome in extremis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Survanta®; Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.	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).
Active Comparator: Curosurf®; Curosurf® (Cornerstone Therapeutics, Inc., Cary, NC Surfactant will be administered by respiratory therapist not involved in patient's care.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dynamic compliance	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.	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.

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Cornerstone Pharmaceuticals
• Investigators: Principal Investigator: Steven Donn, M.D., University of Michigan C & W Mott Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants; Poractant alfa; Beractant
• Other Study ID Numbers: Curosurf-Survanta-UM13888