Functional Residual Capacity, Pulmonary Function Testing, Respiratory Compliance
Conditions
Keywords
premature delivery, respiratory distress syndrome
Brief summary
One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.
Detailed description
The primary purpose of this randomized, blinded placebo controlled trial is to quantify and compare measurements of pulmonary function (including respiratory compliance and lung volumes/functional residual capacity) of hospitalized preterm infants whose mothers received an initial course of antenatal corticosteroids, remained undelivered after 14 days and at \< 34 weeks of gestation, and were then randomized to either a rescue course of antenatal corticosteroids or to a rescue course of placebo. In addition, follow-up pulmonary function tests, clinical outcomes, growth parameters, and the neurodevelopmental outcome of these infants will be followed.
Interventions
DRUGbetamethasone
12 mg IM q 24 hours x 2 doses
DRUGplacebo
Placebo IM q 24 hours x 2 doses
Sponsors
American Lung Association
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Greater than 14 days after first course of antenatal steroids; * Less than 34 weeks of gestation; * Identified by primary physician as continued risk for preterm delivery; * Informed consent
Exclusion criteria
* Major congenital anomalies * Multiple gestation of triplets or greater * Mother with insulin dependent diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurements of Functional Residual Capacity in Preterm Infants. | Within first 72 hours after birth |
| Measurements of Respiratory Compliance (Crs) in Preterm Infants. | Within first 72 hours after birth |
Secondary
| Measure | Time frame |
|---|---|
| FiO2 | During initial hospital stay and planned follow-up |
Countries
United States
Participant flow
Recruitment details
This randomized trial was conducted at Oregon Health and Science University in Portland, OR and at Sacred Heart Hospital in Pensacola, FL. Subjects were recruited from June 2001 to May 2007.
Pre-assignment details
Women who showed no further signs of preterm delivery after consent were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| A (Betamethasone) Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
betamethasone: 12 mg IM q 24 hours x 2 doses | 44 |
| B (Placebo) Placebo dose IM q 24 hours x 2 doses
placebo: Placebo IM q 24 hours x 2 doses | 41 |
| Total | 85 |
Baseline characteristics
| Characteristic | B (Placebo) | A (Betamethasone) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 44 Participants | 85 Participants |
| Age, Continuous | 28.6 years STANDARD_DEVIATION 6.4 | 26.9 years STANDARD_DEVIATION 7.5 | 27.7 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 41 participants | 44 participants | 85 participants |
| Sex: Female, Male Female | 41 Participants | 44 Participants | 85 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
Measurements of Functional Residual Capacity in Preterm Infants.
Time frame: Within first 72 hours after birth
Population: Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A (Betamethasone) | Measurements of Functional Residual Capacity in Preterm Infants. | 24.8 mL/kg | Standard Deviation 8.8 |
| B (Placebo) | Measurements of Functional Residual Capacity in Preterm Infants. | 22.0 mL/kg | Standard Deviation 7.9 |
Primary
Measurements of Respiratory Compliance (Crs) in Preterm Infants.
Time frame: Within first 72 hours after birth
Population: Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A (Betamethasone) | Measurements of Respiratory Compliance (Crs) in Preterm Infants. | 1.21 mL/cm H2O/kg | Standard Deviation 0.53 |
| B (Placebo) | Measurements of Respiratory Compliance (Crs) in Preterm Infants. | 1.01 mL/cm H2O/kg | Standard Deviation 0.51 |
Secondary
FiO2
Time frame: During initial hospital stay and planned follow-up
Population: Number of participants is greater here as it includes all offspring, including twins.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A (Betamethasone) | FiO2 | FiO2 greater or equal to 0.30 | 7 Participants |
| A (Betamethasone) | FiO2 | FiO2 greater or equal to 0.40 | 5 Participants |
| B (Placebo) | FiO2 | FiO2 greater or equal to 0.30 | 16 Participants |
| B (Placebo) | FiO2 | FiO2 greater or equal to 0.40 | 13 Participants |