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

Respiratory Distress Syndrome Clinical Trial

— NEOSURF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834624
• Other study ID #: 1206415
• Status: Completed
• Phase: N/A
• First received: May 19, 2016
• Last updated: October 24, 2016
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Weeks to 35 Weeks

Eligibility

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

• RDS as 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University of Missouri, Women's and Children's Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Inflammation	measurement of c-reactive protein in blood	baseline and at 24 hours and 48 hours after intervention.	Yes
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.	Review of subject charts at study conclusion	intraoperative	No
Secondary	Pulmonary Hemorrhage	Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.	intraoperative	Yes
Secondary	Change in number of tracheal macrophages	measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate	baseline and at 24 hours and 48 hours after intervention.	No