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Completed

NCT Number: NCT02834624

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases

Age range

22 week–35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Columbia, Missouri, 65201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Curosurf

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

Other names: Infasurf

Primary outcomes

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

    Time frame: baseline, 48 hours

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

Secondary outcomes

  1. Presence of Pulmonary Hemorrhage

    Time frame: intraoperative

    Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.

  2. Change in Number of Tracheal Macrophages

    Time frame: baseline, 48 hours

    measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Acronym: NEOSURF

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2016
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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