Respiratory Distress Syndrome
Conditions
Keywords
surfactant, respiratory distress syndrome, inflammation, c-reactive protein, lipid peroxidation
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.
Interventions
DRUGPoractant 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.
DRUGcalfactant
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
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 35 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Blood C-reactive (CRP) Protein | baseline, 48 hours | Difference between measurement of CRP at baseline and 48 hours after administration of surfactant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Pulmonary Hemorrhage | intraoperative | Significant and Persistent Blood present in the trachea during endotracheal tube suctioning. |
| Change in Number of Tracheal Macrophages | baseline, 48 hours | measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate |
Countries
United States
Participant flow
Recruitment details
Infants \< 35 weeks gestation requiring intubation and surfactant for Respiratory Distress Syndrome. Infants with suspected congenital infection, major birth defects, known chromosomal disorder, cord blood pH \< 7.0, or Apgar score of 3 or \< at 10 minutes were excluded. The infants were randomized to receive either Poractant or Calfactant.
Participants by arm
| Arm | Count |
|---|---|
| Poractant Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. | 15 |
| Calfactant Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Poractant | Calfactant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex/Gender, Customized Unknown | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change From Baseline in Blood C-reactive (CRP) Protein
Difference between measurement of CRP at baseline and 48 hours after administration of surfactant
Time frame: baseline, 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poractant | Change From Baseline in Blood C-reactive (CRP) Protein | 1.300 mg/dL | Standard Deviation 1.644 |
| Calfactant | Change From Baseline in Blood C-reactive (CRP) Protein | 0.193 mg/dL | Standard Deviation 0.337 |
Comparison: Sample size calculations used a Chi-square for independence, u = 1, p =.05, power = .80, effect size = .60, which required 22 total subjects.p-value: <0.05t-test, 1 sided
Secondary
Change in Number of Tracheal Macrophages
measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate
Time frame: baseline, 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poractant | Change in Number of Tracheal Macrophages | 2.3 white cells/high-powered field | Standard Deviation 1.8 |
| Calfactant | Change in Number of Tracheal Macrophages | 2.0 white cells/high-powered field | Standard Deviation 1.2 |
p-value: 0.63t-test, 1 sided
Secondary
Presence of Pulmonary Hemorrhage
Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.
Time frame: intraoperative
Population: This data is unavailable from the research department as it was not collected.