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

• ClinicalTrials.gov Identifier: NCT02834624
• Recruitment Status: Completed
• First Posted: July 15, 2016
• Results First Posted: June 6, 2017
• Last Update Posted: June 6, 2017
• Sponsor: University of Missouri-Columbia
• Information provided by (Responsible Party): University of Missouri-Columbia

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome	Drug: Poractant alfa; Drug: calfactant	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
• Study Start Date: July 2013
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

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 Name: 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 Name: Curosurf

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Blood C-reactive (CRP) Protein [ Time Frame: baseline, 48 hours ]
   Difference between measurement of CRP at baseline and 48 hours after administration of surfactant

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 22 Weeks to 35 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Missouri

University of Missouri, Women's and Children's Hospital

Columbia, Missouri, United States, 65201

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

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

More Information

• Responsible Party: University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT02834624
• Other Study ID Numbers: 1206415
• First Posted: July 15, 2016
• Results First Posted: June 6, 2017
• Last Update Posted: June 6, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:

surfactant; respiratory distress syndrome; inflammation; c-reactive protein; lipid peroxidation

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Poractant alfa; Calfactant; Pulmonary Surfactants; Respiratory System Agents