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

NCT ID: NCT02834624

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

calfactant

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Poractant alfa

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Curosurf; Infasurf

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

• Minimum Eligible Age: 22 Weeks
• Maximum Eligible Age: 35 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Lauriello, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri, Women's and Children's Hospital

Columbia, Missouri, United States

Countries

United States

Other Identifiers

1206415

Identifier Type: -

Identifier Source: org_study_id