Trial Outcomes & Findings for Nasal Noninvasive NAVA in the Very Low Birth Weight Infant (NCT NCT01785563)

Last Updated: 2022-06-09

Results Overview

difference between pCO2 (mm Hg) on capillary blood gas obtained within 6 hours of study and immediately after 2 hour study period

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

2 hours

Results posted on

2022-06-09

Participant milestones
Measure	Nasal Non-Invasive NAVA Group Infants \< 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
Overall Study STARTED	40
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	13

Reasons for withdrawal
Measure	Nasal Non-Invasive NAVA Group Infants \< 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
Overall Study Physician Decision	10
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	2

Nasal Noninvasive NAVA in the Very Low Birth Weight Infant

Baseline characteristics by cohort
Measure	Nasal Non-Invasive NAVA Group n=27 Participants Infants \< 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
Age, Categorical <=18 years	27 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	47 days STANDARD_DEVIATION 29 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants
screening capillary blood gas pH	7.38 ph units n=5 Participants

Timeframe: 2 hours

difference between pCO2 (mm Hg) on capillary blood gas obtained within 6 hours of study and immediately after 2 hour study period

Outcome measures
Measure	Nasal Non-Invasive NAVA Group n=27 Participants Infants \< 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas	0.019 mm Hg Standard Deviation 0.037

Timeframe: 2 hours

difference between fiO2 at start of study and that at the last measurement timepoint at 120 minutes

Outcome measures
Measure	Nasal Non-Invasive NAVA Group n=27 Participants Infants \< 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
Change in Fraction of Inspired Oxygen	-0.012 percentage of oxygen in inspired gas Standard Deviation 0.0463

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Iowa

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