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

University of Michigan

Status: Withdrawn

Conditions: Respiratory Distress Syndrome

Treatments: Drug: Curosurf®; Drug: Survanta®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01537354

Curosurf-Survanta-UM13888

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 15 minutes to 12 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Survanta®

Active Comparator group

Description:

Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.

Treatment:

Drug: Survanta®

Curosurf®

Active Comparator group

Description:

Curosurf® (Cornerstone Therapeutics, Inc., Cary, NC Surfactant will be administered by respiratory therapist not involved in patient's care.

Treatment:

Drug: Curosurf®