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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01537354
Other study ID # Curosurf-Survanta-UM13888
Secondary ID
Status Withdrawn
Phase N/A
First received February 13, 2012
Last updated January 7, 2014
Start date June 2012

Study information

Verified date January 2014
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Hours
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
United States University of Michigan C & W Mott Children's Hospital Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Cornerstone Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
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