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

NCT02834624 | Completed Results

• 1 other identifier: 1206415
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome

Keywords

surfactant; respiratory distress syndrome; inflammation; c-reactive protein; lipid peroxidation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Blood C-reactive (CRP) Protein

  Difference between measurement of CRP at baseline and 48 hours after administration of surfactant

  baseline, 48 hours

Secondary Outcomes (2)

• Presence of Pulmonary Hemorrhage

  intraoperative

• Change in Number of Tracheal Macrophages

  baseline, 48 hours

Study Arms (2)

Calfactant

ACTIVE COMPARATOR

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.

Drug: calfactant

Poractant Alfa

ACTIVE COMPARATOR

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.

Drug: Poractant alfa

Interventions

Poractant alfa 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.

Also known as: Curosurf

Poractant Alfa

calfactant 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

Also known as: Infasurf

Calfactant

Eligibility Criteria

• Age: 22 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

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

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Inflammation

Interventions

poractant alfa; calfactant

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Naomi Lauriello
• Organization: University of Missouri-Columbia

lauriellon@health.missouri.edu

573-882-2272

Study Officials

• Naomi Lauriello, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: July 15, 2016
• Study Start: July 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)