Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome (NEOSURF)

Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.

The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Drug: calfactant; Drug: Poractant alfa

Detailed Description

30 infants were randomized to receive either poractant or calfactant for Respiratory Distress Syndrome.

Tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri, Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrolled prior to delivery with signed informed consent and HIPAA by parents
• Gestational age of less than 35 weeks
• No maternal chorioamnionitis of other maternal or fetal infection
• Respiratory Distress Syndrome (RDS) determined by the attending neonatologist that needs to be treated with exogenous surfactant and mechanical ventilation

Exclusion Criteria:

• Major Birth Defect, Malformation Syndrome
• Chromosomal or Inherited Metabolic Disorder
• Proven Presence of an Immunodeficiency
• Antenatal exposure of illicit substance (e.g., methamphetamines, cocaine, etc., but not marijuana)
• Birth Asphyxia (cord pH <7.0, Apgar score of 3 or less at 10 minutes of age)
• HIV or other congenital viral, bacterial or fungal infection
• Lack of Parental consent of refusal of attending neonatologist to allow participation
• Discretion of the investigator
• The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Calfactant; Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.	Drug: calfactant; Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist; Other Names: Infasurf
Active Comparator: Poractant Alfa; Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.	Drug: Poractant alfa; Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.; Other Names: Curosurf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Blood C-reactive (CRP) Protein	Difference between measurement of CRP at baseline and 48 hours after administration of surfactant	baseline, 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Pulmonary Hemorrhage	Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.	intraoperative
Change in Number of Tracheal Macrophages	measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate	baseline, 48 hours

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Naomi Lauriello, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: inflammation; respiratory distress syndrome; surfactant; c-reactive protein; lipid peroxidation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants; Calfactant; Poractant alfa
• Other Study ID Numbers: 1206415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No