Trial Outcomes & Findings for Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates (NCT NCT01116921)

NCT ID: NCT01116921

Last Updated: 2017-02-27

Results Overview

"Treatment Failure" criteria were the same for both groups. "Treatment Failure" required two of the following: 1) FiO2 \>40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 \>65mmHg on ABG/CBG or \>70 on VBG, or 3) pH\<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 \>40%, or 4) deemed necessary by medical provider.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: Seven days
• Results posted on: 2017-02-27

Participant Flow

Participant milestones

Measure	nCPAP Control Group Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Overall Study STARTED	53	50
Overall Study COMPLETED	53	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

Baseline characteristics by cohort

Measure	nCPAP Control Group n=53 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	53 Participants n=5 Participants	50 Participants n=7 Participants	103 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	32.86 weeks STANDARD_DEVIATION 1.86 • n=5 Participants	32.71 weeks STANDARD_DEVIATION 1.86 • n=7 Participants	32.71 weeks STANDARD_DEVIATION 1.86 • n=5 Participants
Gender Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Gender Male	35 Participants n=5 Participants	30 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants	50 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

Timeframe: Seven days

"Treatment Failure" criteria were the same for both groups. "Treatment Failure" required two of the following: 1) FiO2 >40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 >65mmHg on ABG/CBG or >70 on VBG, or 3) pH<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 >40%, or 4) deemed necessary by medical provider.

Outcome measures

Measure	nCPAP Control Group n=53 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.	34 Participants	19 Participants

SECONDARY outcome

Timeframe: During first seven days of life

Outcome measures

Measure	nCPAP Control Group n=53 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Duration of CPAP Therapy	50 hours Standard Deviation 41	56 hours Standard Deviation 35

SECONDARY outcome

Timeframe: During first seven days of life

Outcome measures

Measure	nCPAP Control Group n=53 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Duration of Oxygen Therapy	55 hours Standard Deviation 41	56 hours Standard Deviation 45

SECONDARY outcome

Timeframe: First 7 days of life

Outcome measures

Measure	nCPAP Control Group n=53 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Incidence of Pulmonary Airleaks	5 Participants	4 Participants

SECONDARY outcome

Timeframe: During hospitalization

Outcome measures

Measure	nCPAP Control Group n=53 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Incidence of Severe IVH or PVL	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured at hospital discharge

Outcome measures

Measure	nCPAP Control Group n=53 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 Participants Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Incidence of Chronic Lung Disease	0 Participants	2 Participants

Adverse Events

nCPAP Control Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

LMA Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	nCPAP Control Group n=53 participants at risk Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.	LMA Group n=50 participants at risk Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Respiratory, thoracic and mediastinal disorders Pneumothorax	9.4% 5/53 • Number of events 5	8.0% 4/50 • Number of events 4

Additional Information

Kari D. Roberts, MD

Unviersity of Minnesota

Phone: 612-625--9577

Email: rober694@umn.edu

Results disclosure agreements

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