A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants

Apnea of Prematurity Clinical Trial

Official title:

A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298035
• Other study ID #: HSC-MS-17-0458
• Status: Completed
• Phase: N/A
• Start date: November 11, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Infants born at < 30 weeks gestational age who develop clinically significant apnea while on NCPAP > 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.

• Infants on maximum caffeine therapy (10mg/kg/day)

Exclusion Criteria:

• Major congenital anomalies including congenital heart disease

Related Conditions & MeSH terms

• Apnea
• Apnea of Prematurity
• Birth Weight

Intervention

Device:
• NCPAP as mode for apnea prevention
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
• NIPPV as rescue mode for apnea prevention
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Were Intubated		28 days after randomization
Primary	Duration of Intubation		28 days after randomization
Secondary	Number of Apneic Events		28 days after randomization
Secondary	Number of Participants With Bronchopulmonary Dysplasia (BPD)		36 weeks corrected gestational age
Secondary	Number of Participants With Necrotizing Enterocolitis (NEC)		36 weeks corrected gestational age
Secondary	Number of Participants With Air Leak Disorders	Air leak disorders include pneumothorax and/or pneumomediastinum.	36 weeks corrected gestational age
Secondary	Weight Gain		36 weeks corrected gestational age
Secondary	Length of Hospital Stay		about 10 to 18 weeks
Secondary	Number of Participants Who Died		until discharge (about 10 to 18 weeks) or death