search
Back to results

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

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Poractant alfa
calfactant
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring surfactant, respiratory distress syndrome, inflammation, c-reactive protein, lipid peroxidation

Eligibility Criteria

22 Weeks - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Calfactant

Poractant Alfa

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Presence of Pulmonary Hemorrhage
Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.
Change in Number of Tracheal Macrophages
measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate

Full Information

First Posted
May 19, 2016
Last Updated
May 8, 2017
Sponsor
University of Missouri-Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT02834624
Brief Title
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Acronym
NEOSURF
Official Title
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
surfactant, respiratory distress syndrome, inflammation, c-reactive protein, lipid peroxidation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calfactant
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Poractant Alfa
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Poractant alfa
Other Intervention Name(s)
Curosurf
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
calfactant
Other Intervention Name(s)
Infasurf
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Blood C-reactive (CRP) Protein
Description
Difference between measurement of CRP at baseline and 48 hours after administration of surfactant
Time Frame
baseline, 48 hours
Secondary Outcome Measure Information:
Title
Presence of Pulmonary Hemorrhage
Description
Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.
Time Frame
intraoperative
Title
Change in Number of Tracheal Macrophages
Description
measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate
Time Frame
baseline, 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Lauriello, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri, Women's and Children's Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs