Respiratory Distress Syndrome In Premature Infants
Conditions
Keywords
High Frequency Oscillatory Ventilation, Infant, Very Low Birth Weight, Periventricular Leukomalacia, Intraventricular Hemorrhage, multi-center study
Brief summary
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive respiratory support in the treatment of respiratory distress.
Detailed description
Results from this single-arm, multi-center clinical study are intended to evaluate the safety and effectiveness of the Babylog VN500 device in high frequency oscillatory ventilation (HFOV) mode in very low birth weight (VLBW) neonates of 23 to 30 weeks' gestational age (400 g to 1200 g, inclusive) with documented respiratory distress requiring invasive respiratory support. The safety will be determined by evaluating the rate of subjects alive at Day 32 and free of Grade III/IV intraventricular hemorrhage (IVH) or cystic periventricular leukomalacia. Evaluation of the Alveolar-arterial (A-a) gradient 12 hours after start of ventilation will account for the effectiveness.
Interventions
DEVICEBabylog VN500 in HFOV Mode
Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days
Sponsors
Draeger Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 30 Weeks
Healthy volunteers
No
Inclusion criteria
* Gestational Age between 23 to 30 weeks; within first 4 days of life * very low birth weight between 400 g and 1200 g, inclusive * 5-minute Apgar score \>3 * documented respiratory distress requiring invasive respiratory Support * A priori: primary intention for either HFOV or high-frequency jet ventilation OR Severity of Illness: mechanical ventilation with a fraction of inspired oxygen of ≥ 0.25% and a mean airway pressure of ≥ 7 cm H2O, more than 2 hours after an initial dose of surfactant required and clinical care team believes that treatment with HFOV is indicated * anticipated availability of investigational device at the study center before screening for enrollment * written informed consent to participate in the study provided by a parent or legal guardian
Exclusion criteria
* anticipation to require intubation and mechanical ventilation for less than 12 hours * previous exposure to any mechanical ventilation for ≥ 96 hours before planned HFOV treatment * obvious chromosomal or major congenital abnormalities involving the respiratory tract or upper airway * known congenital heart disease, excluding Patent Ductus Arteriosus (PDA), ventricular-septal defect, or atrial-septal defect * pre-existing air leak, including pneumothorax, pneumomediastinum, pneumopericardium, or extensive bilateral Pulmonary Interstitial Emphysema (PIE) * severe metabolic acidosis with a base deficit of ≥ 15 before planned HFOV treatment * severe hypotension (a mean blood pressure more than 2 standard deviations below the mean neonate's birth weight despite a total combined dose of dopamine, dobutamine, or both, of 20 µg(kg/min) * moribund subject not expected to survive, or a subject in whom there is a decision to limit care * currently receiving or previous treatment with inhaled nitric oxide * currently receiving or previous treatment with corticosteroids specifically for BPD prevention * evidence of severe sepsis (neutropenia, severe hypotension, shock) * evidence of Nectrotising Enterocolitis (NEC), defined as Modified Bell's Stage II or greater * documented Grade III/IV intraventricular hemorrhage * current enrollment in another Investigational Device Exemption or Investigational New Drug clinical study where treatment, testing, or follow-up may interfere with the results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL) | Day 32 +/- 10 days gestational age | Papile's grading on cranial ultrasound |
| Alveolar-arterial (A-a) Gradient change | 12 hours after onset of HFOV treatment | A-a Gradient as measured by arterial blood gas after onset of Treatment with the Babylog VN500 in HFOV mode |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopment assessment | 22 - 24 months corrected age | Bayley Scales of Infant and Toddler Development III |
| Change of partial carbon dioxide pressure (PaCO2) | 2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment | Duration of time and amount that the carbon dioxide Tension values are outside the target range of 40 to 55 mmHg |
| Relationship between tidal volume high frequency (Vthf) set and Vthf observed | 2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment | difference between mean Vthf set and mean Vthf observed |
| Freedom from study-defined serious adverse events | during Treatment Phase (up to 14 days) | Events related to the Condition of Prematurity and the requirement for invasive respiratory suppport |
| Freedom from Bronchopulmonary Dysplasia (BPD) | 36 week's corrected age | Need for any oxygen or positive airway pressure |
| Length and Type of Respiratory Support | participants will be followed for the duration of hospital stay, an expected average of 14 weeks | invasive ventilator support, supplemental oxygen, positive pressure support |
| Neonatal survival | participants will be followed for the duration of hospital stay, an expected average of 14 weeks | survival with and without the need for supplemental oxygen |
| Stability of Vthf observed and carbon dioxide diffusion (DCO2) coefficient monitoring during high frequency oscillation over time | first 48 hours of HFOV treatment | this outcome will be evaluated during periods when no changes to ventilator settings are made. During the first 48 hours of treatment with the investigational device, ventilator settings, VThf and DCO2 will be downloaded from the ventilator's memory along with Ventilator settings for subsequent analysis. |
| Device failure rate | during Treatment Phase (up to 14 days) | malfunction of the investigational device necessitating removal of a neonate to another Ventilation mode or ventilator |
Countries
United States
Outcome results
None listed