Clinical trial NCT01242462: Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
Official title: Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Conventional mechanical ventilation
Mid-frequency ventilation
Respiratory Distress Syndrome
Preterm Newborn Infant
Mean Airway Pressure
Mean Arterial Pressure
Mean Peak Inspiratory Pressure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants. Despite improved survival of extremely premature infants with RDS, complications related to mechanical ventilation still occur. This trial will attempt to maintain adequate gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A cross over design will be used to test the hypothesis whether mid-frequency ventilation in preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory pressure requirement when compared to conventional mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Inborn newborn infants with birthweight greater than or equal to 500gms, with gestational age greater than or equal to 24 weeks but less than or equal to 36 weeks.
* Postnatal age less than or equal to 7 days.
* Infant with respiratory distress syndrome (RDS) on mechanical ventilation with less than or equal to 60 breaths/minute, initially requiring greater than or equal to 30% FiO2.
* Written informed consent.

Exclusion Criteria:

* Blood culture positive sepsis, life threatening congenital anomalies, cyanotic congenital heart diseases, hydrops fetalis, outborn infants, non viability as determined by the attending physician, and newborns who are considered too unstable for study enrollment as per neonatology attending/fellow.

Primary outcomes:
measure: Average delta pressure
timeFrame: 4 hours
Secondary outcomes:
measure: Average Mean Airway Pressure (MAP)
timeFrame: Less than 4 hours
measure: Mean arterial pressure
timeFrame: Less than 4 hours
measure: Average delta pressure
timeFrame: Less than 4 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ramanchandra Bhat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: John Kelleher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhat R, Kelleher J, Ambalavanan N, Chatburn RL, Mireles-Cabodevila E, Carlo WA. Feasibility of Mid-Frequency Ventilation Among Infants With Respiratory Distress Syndrome. Respir Care. 2017 Apr;62(4):481-488. doi: 10.4187/respcare.05157. Epub 2017 Jan 3.