Trial Outcomes & Findings for Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator (NCT NCT01440647)

NCT ID: NCT01440647

Last Updated: 2013-03-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 30 days from birth
• Results posted on: 2013-03-12

Participant Flow

Participant milestones

Measure	NIPPV Extubation to NIPPV (nasal intermittent positive pressure ventilation)	CPAP After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life
Overall Study STARTED	16	18
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	NIPPV Extubation to NIPPV (nasal intermittent positive pressure ventilation)	CPAP After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life
Overall Study Death	2	3

Baseline Characteristics

Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator

Baseline characteristics by cohort

Measure	NIPPV n=16 Participants Extubation to NIPPV (nasal intermittent positive pressure ventilation)	CPAP n=18 Participants After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous Gestational age in weeks	26.1 weeks STANDARD_DEVIATION 1.1 • n=5 Participants	25.7 weeks STANDARD_DEVIATION 1.1 • n=7 Participants	25.9 weeks STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	18 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days from birth

Outcome measures

Measure	NIPPV n=16 Participants Extubation to NIPPV when reaching extubation criteria	CPAP n=18 Participants Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
Number of Days Being Intubated	12.4 days Interval 0.3 to 29.5	6.2 days Interval 0.5 to 30.0

SECONDARY outcome

Timeframe: 0-7 days post-extubation

Reintubation rate is a measure of the efficacy of NIPPV.

Outcome measures

Measure	NIPPV n=16 Participants Extubation to NIPPV when reaching extubation criteria	CPAP n=18 Participants Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
Percentage of Participants With Reintubation	67 % of participants with reintubation	28 % of participants with reintubation

Adverse Events

NIPPV

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

CPAP

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	NIPPV n=16 participants at risk Extubation to NIPPV (nasal intermittent positive pressure ventilation)	CPAP n=18 participants at risk After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
General disorders Death	12.5% 2/16 • Number of events 2 • Participants were followed until discharge from the hospital for an average of 100 days.	16.7% 3/18 • Number of events 3 • Participants were followed until discharge from the hospital for an average of 100 days.

Other adverse events

Adverse event data not reported

Additional Information

Abbot R. Laptook, MD, Professor of Pediatrics The Warren Alpert Medical School of Brown University M

Women & Infants Hospital of Rhode Island

Phone: 401-274-1122

Email: ALaptook@WIHRI.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place