N/A N=30 Randomized Triple-blind Treatment

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

Respiratory Distress Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02834624 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Change From Baseline in Blood C-reactive (CRP) Protein — 1.300; 0.193 mg/dL — p=<.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Poractant alfa (Drug); calfactant (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Missouri-Columbia
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Blood C-reactive (CRP) Protein	1.300; 0.193	<.05 sig
SECONDARY Presence of Pulmonary Hemorrhage	—	—
SECONDARY Change in Number of Tracheal Macrophages	2.3; 2.0	0.63

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02834624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.