Trial Outcomes & Findings for Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation (NCT NCT01042600)

NCT ID: NCT01042600

Last Updated: 2019-07-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 61 participants
• Primary outcome timeframe: 96 hours
• Results posted on: 2019-07-26

Participant Flow

One participant excluded and removed from study after randomization due to ineligibility (pre-existing pneumothorax)

Participant milestones

Measure	Endotracheal Intubation Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Overall Study STARTED	31	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Endotracheal Intubation Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Overall Study Ineligible	1	0

Baseline Characteristics

Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation

Baseline characteristics by cohort

Measure	Endotracheal Intubation n=31 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)	Total n=61 Participants Total of all reporting groups
Age, Customized Gestational age <33 weeks	18 participants n=93 Participants	11 participants n=4 Participants	29 participants n=27 Participants
Age, Customized Gestational age >=33 weeks	13 participants n=93 Participants	19 participants n=4 Participants	32 participants n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	9 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	21 Participants n=4 Participants	39 Participants n=27 Participants

PRIMARY outcome

Timeframe: 96 hours

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).	23 participants	9 participants

SECONDARY outcome

Timeframe: 96 hr

Mean number of surfactant doses

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Number of Surfactant Doses	1.3 mean doses Standard Deviation .6	1.8 mean doses Standard Deviation 1.0

SECONDARY outcome

Timeframe: 2 months

Days on any respiratory support

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Days on Assisted Ventilation	11 days Interval 7.0 to 21.0	8.5 days Interval 6.0 to 22.0

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Days on Supplemental Oxygen	10 days Interval 6.0 to 20.0	7.5 days Interval 4.0 to 19.0

SECONDARY outcome

Timeframe: 96 hrs

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Rate of Pneumothorax	13 percentage of participants	20 percentage of participants

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)	7 percentage of participants	10 percentage of participants

SECONDARY outcome

Timeframe: 96 hrs

LMA insertion complications (e.g. trauma, failure of insertion)

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Complications During Insertion of LMA	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Measure	Endotracheal Intubation n=30 Participants Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 Participants Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Mortality Rate	0 participants	0 participants

Adverse Events

Endotracheal Intubation

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Laryngeal Mask Airway

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Endotracheal Intubation n=30 participants at risk Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)	Laryngeal Mask Airway n=30 participants at risk Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)
Cardiac disorders Bradycardia	20.0% 6/30 • Number of events 6	6.7% 2/30 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pneumothorax	13.3% 4/30 • Number of events 4	20.0% 6/30 • Number of events 6

Additional Information

Joaquim Pinheiro, MD, MPH

Albany Medical Center

Phone: 518-262-5421

Email: pinheij@mail.amc.edu

Results disclosure agreements

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