Clinical trial NCT01537354: Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
Official title: A Comparison of Immediate Changes in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Cornerstone Pharmaceuticals
First posted: 2012-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in dynamic compliance
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan C & W Mott Children's Hospital
state: Michigan
Study officials:
affiliation: University of Michigan C & W Mott Children's Hospital
name: Steven Donn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: