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

University of Missouri (MU)

Status: Completed

Conditions: Respiratory Distress Syndrome

Treatments: Drug: calfactant; Drug: Poractant alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT02834624

1206415

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 22 to 35 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Calfactant

Active Comparator group

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.

Treatment:

Drug: calfactant

Poractant Alfa

Active Comparator group

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.

Treatment:

Drug: Poractant alfa