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

This study has been withdrawn prior to enrollment.
(Sponsor discontinued clinical trial before enrollment of subjects.)
Sponsor:
Collaborator:
Cornerstone Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Steven Donn, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01537354
First received: February 13, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome
Drug: Curosurf®
Drug: Survanta®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Immediate Changes in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in dynamic compliance [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: June 2012
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537354

Locations
United States, Michigan
University of Michigan C & W Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-0245
Sponsors and Collaborators
University of Michigan
Cornerstone Pharmaceuticals, Inc.
Investigators
Principal Investigator: Steven Donn, M.D. University of Michigan C & W Mott Children's Hospital
  More Information

No publications provided

Responsible Party: Steven Donn, M.D., Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01537354     History of Changes
Other Study ID Numbers: Curosurf-Survanta-UM13888
Study First Received: February 13, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Beractant
Poractant alfa
Pharmacologic Actions
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014