Trial Outcomes & Findings for Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome (NCT NCT02164734)

NCT ID: NCT02164734

Last Updated: 2023-09-21

Results Overview

Failure of surfactant therapy in avoiding invasive mechanical ventilation or clinically equivalent outcomes (FiO2 \> 0.60 to maintain target SpO2, second dose of surfactant within 8 hours, or more than 2 total doses of surfactant)

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 93 participants
• Primary outcome timeframe: 120 hours
• Results posted on: 2023-09-21

Participant Flow

Participant milestones

Measure	Endotracheal Intubation Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Overall Study STARTED	42	51
Overall Study COMPLETED	42	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome

Baseline characteristics by cohort

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway	Total n=93 Participants Total of all reporting groups
Age, Continuous	31.6 Gestational weeks STANDARD_DEVIATION 2.6 • n=5 Participants	31.7 Gestational weeks STANDARD_DEVIATION 2.1 • n=7 Participants	31.7 Gestational weeks STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	30 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	49 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	47 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	51 participants n=7 Participants	93 participants n=5 Participants
Birth weight (grams)	1848 grams STANDARD_DEVIATION 676 • n=5 Participants	1926 grams STANDARD_DEVIATION 555 • n=7 Participants	1891 grams STANDARD_DEVIATION 610 • n=5 Participants

PRIMARY outcome

Timeframe: 120 hours

Population: Analysis by intention-to-treat

Failure of surfactant therapy in avoiding invasive mechanical ventilation or clinically equivalent outcomes (FiO2 > 0.60 to maintain target SpO2, second dose of surfactant within 8 hours, or more than 2 total doses of surfactant)

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Number of Participants Failing to Avoid Invasive Mechanical Ventilation	12 Participants	10 Participants

SECONDARY outcome

Timeframe: 120 hours

Mean number of surfactant doses per patient

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Number of Surfactant Doses	1.6 surfactant doses Standard Deviation 0.7	1.6 surfactant doses Standard Deviation 0.8

SECONDARY outcome

Timeframe: 3 months

Days on any respiratory support (i.e., other than breathing room air)

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Days on Any Respiratory Support	9 days Interval 6.0 to 25.0	9 days Interval 6.0 to 21.0

SECONDARY outcome

Timeframe: 120 hours

proportion of participants with pneumothorax diagnosed radiologically or by transillumination

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Rate of Pneumothorax	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 3 months

Defined as oxygen requirement at 36 weeks postmenstrual age if gestational age less than 33 weeks, or beyond 28 days of age if gestational age greater than 32 weeks

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Rate of Bronchopulmonary Dysplasia (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 120 hours

bradycardia, airway obstruction, or cardiopulmonary resuscitation

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Number of Participants With Complications During Insertion of LMA or Endotracheal Tube	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

Mortality prior to hospital discharge (any cause)

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Mortality Rate	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 hour

need of mechanical ventilation within 1 hour of surfactant therapy

Outcome measures

Measure	Endotracheal Intubation n=42 Participants Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Number of Participants With Early Failure of Surfactant Therapy	5 Participants	1 Participants

Adverse Events

Endotracheal Intubation

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Laryngeal Mask Airway

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Endotracheal Intubation n=42 participants at risk Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 participants at risk Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Cardiac disorders cardiopulmonary resuscitation	2.4% 1/42 • Number of events 1 • 3 months or NICU discharge bradycardia	0.00% 0/51 • 3 months or NICU discharge bradycardia

Other adverse events

Measure	Endotracheal Intubation n=42 participants at risk Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm	Laryngeal Mask Airway n=51 participants at risk Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway
Cardiac disorders bradycardia	2.4% 1/42 • Number of events 1 • 3 months or NICU discharge bradycardia	2.0% 1/51 • Number of events 1 • 3 months or NICU discharge bradycardia
Respiratory, thoracic and mediastinal disorders airway obstruction	4.8% 2/42 • Number of events 2 • 3 months or NICU discharge bradycardia	0.00% 0/51 • 3 months or NICU discharge bradycardia

Additional Information

Joaquim Pinheiro, MD, MPH

Albany Medical Center

Phone: 518-262-5421

Email: pinheij@amc.edu

Results disclosure agreements

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