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

NCT ID: NCT01537354

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Survanta®

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

Group Type: ACTIVE_COMPARATOR

Survanta®

Intervention Type: DRUG

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).

Curosurf®

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

Group Type: ACTIVE_COMPARATOR

Curosurf®

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 15 Minutes
• Maximum Eligible Age: 12 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cornerstone Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Steven Donn, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Donn, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan C & W Mott Children's Hospital

Locations

University of Michigan C & W Mott Children's Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Curosurf-Survanta-UM13888

Identifier Type: -

Identifier Source: org_study_id