Clinical trial NCT02834624: Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Official title: Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: surfactant
respiratory distress syndrome
inflammation
c-reactive protein
lipid peroxidation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Blood C-reactive (CRP) Protein
timeFrame: baseline, 48 hours
Secondary outcomes:
measure: Presence of Pulmonary Hemorrhage
timeFrame: intraoperative
measure: Change in Number of Tracheal Macrophages
timeFrame: baseline, 48 hours
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri, Women's and Children's Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Naomi Lauriello, MD
role: PRINCIPAL_INVESTIGATOR
References: