Clinical trial NCT02085499: Flow-synchronized Nasal IMV in Preterm Infants
Official title: Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant Disease
Respiratory Insufficiency
Keywords: nasal ventilation
premature infants
synchronized ventilation
non-invasive respiratory support
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased.

The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration.

The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined.

This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen.

The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort.

The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.


Eligibility criteria: Inclusion Criteria:

* Preterm infants of 30 or less weeks of gestational age
* Receiving NIMV
* Requiring Fi02 \> 0.21 to keep Sp02 \> 90%
* Parental written informed consent

Exclusion Criteria:

* Major congenital anomalies
* Proven sepsis within 72 hours of the study
* Hypotension requiring pressors within 72 hours of the study
* Pneumothorax or pneumomediastinum within 72 hours of the study
* Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention

Primary outcomes:
measure: Minute Ventilation
timeFrame: 4 hours
measure: Ttidal volume (VT)
timeFrame: 4 hours
Secondary outcomes:
measure: Arterial oxygen saturation
timeFrame: 4 hours
measure: fraction of inspired oxygen
timeFrame: 4 hours
measure: transcutaneous carbon dioxide tension
timeFrame: 4 hours
Other outcomes:
measure: Inspiratory breathing effort
timeFrame: 4 hours
measure: Chest wall distortion by Tcd/Vt ratio
timeFrame: 4 hours
measure: Chest wall distortion by phase lag
timeFrame: 4 hours
measure: apnea frequency
timeFrame: 4 hours
Locations:
city: Miami
country: United States
facility: Holtz Childrens Hospital-Jackson Health System-University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Nelson Claure, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Eduardo Bancalari, MD
role: PRINCIPAL_INVESTIGATOR
References: