Effects of Automated Adjustment of Inspired Oxygen With Combined Adaptive Mechanical Backup Ventilation as Compared to Automated Oxygen Adjustment Alone in Preterm Infants With Intermittent Hypoxemic Events During Non-invasive Ventilatory Support

NCT02774408 | Unknown

• 1 other identifier: FiO2 Backup
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this 2-phase cross-over study the investigators test the hypothesis that automated adjustment of the inspired oxygen with the combined use of synchronized noninvasive SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the intended oxygen saturation range as compared to automated FiO2 adjustment alone.

Conditions

Apnea, Hypoxia

Keywords

backup ventilation; preterm infants; functional residual capacity; chronic lung disease

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the total duration of time with an arterial oxygen saturation as measured by pulse oxymetry (percentage of the total recording time) within the target range (88-95%).

  48 hours

Secondary Outcomes (8)

• the number of episodes with an SpO2 <80%

  48 hours

• The number of extended/very long episodes outside the SpO2 target range (defined as episodes with a duration of more than 1 minute/3 minutes)

  48 hours

• Mean SpO2.

  48 hours

• Variability of SpO2 (coefficient of variation)

  48 hours

• Mean FiO2 during the study time

  48 hours

Other Outcomes (4)

• the number of episodes with an SpO2 <80%.

  48hours

• the number of episodes with an SpO2 <70%.

  45hours

• the mean duration of episodes with an SpO2 with hyperoxemia (SpO2 >96%).

  48hours

Study Arms (2)

CPAP

OTHER

Infants on CPAP will receive backup breafs whenever the SpO2 \<88 % along with automated FiO2 controller. In the control period they will receive automated FiO2 alone

Device: Saturation sensitive backup ventilation

NIMV/NIPPV

OTHER

Infants on NIMV NIPPV will receive an increase in the backup rate to 2 times the rate of the backup triggered by apnoe (apnoe time 5s), whenever the SpO2 under 88% ( max rate 100/min) in the reference period as compared to baseline (automated FiO2 \- control + unchanged SIPPV settings)

Device: Saturation sensitive backup ventilation

Interventions

Saturation sensitive backup ventilation DEVICE

CPAP; NIMV/NIPPV

Eligibility Criteria

• Age: 96 Hours - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• postmenstrual age \<34 wks GA at study time (\<32 wks GA at birth)
• on nasal/nasopharyngeal CPAP or nasal IMV / IPPV
• at least 4 desaturations (SpO2 \<80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Masimo SET, Irvine, CA, averaging time 8 sec; delay 10s)
• informed consent obtained from the parents or legal guardian

You may not qualify if:

• postnatal age \<96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
• congenital cyanotic heart disease
• no decision for full treatment support
• Average FiO2 during the last 24h bevor the active study phase \>0.60 (too sick for non-invasive ventilator support)
• Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congenital cystic lung diseases...)
• Clinical evidence for seizures
• Ongoing Sepsis with hemodynamic compromise (defined as a CrP \> 20mg/l or positive blood culture (for sepsis), and requirement of catecholamines (for hemodynamic compromise))
• Need of blood-transfusion during study time

Sponsors & Collaborators

• University of Ulm: lead
• Dr. von Hauner Children's Hospital: collaborator

MeSH Terms

Conditions

Apnea; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: May 17, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05