Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates

DrÃ¤ger

Status

Unknown

Conditions

Respiratory Distress Syndrome In Premature Infants

Treatments

Device: Babylog VN500 in HFOV Mode

Study type

Interventional

Funder types

Industry

Identifiers

NCT02445040

I100738

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 estimated patients

Sex

All

Ages

23 to 30 weeks old

Volunteers

No Healthy Volunteers

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