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

Not Applicable

Completed

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.

Recruitment & 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
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

Arm && Interventions

Group	Intervention	Description
Poractant Alfa	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	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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