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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Poractant alfa
* Drug: calfactant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calfactant<br>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<br>* 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<br>* Other names: Infasurf;|
| Active Comparator: Poractant Alfa<br>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<br>* 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.<br>* Other names: Curosurf;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surfactant, respiratory distress syndrome, inflammation, c-reactive protein, lipid peroxidation