Trial Outcomes & Findings for A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants (NCT NCT01709409)

NCT ID: NCT01709409

Last Updated: 2017-10-25

Results Overview

1. rate on ventilator ≤40 per minute and 2. mean airway pressure ≤ 10 cm H20 and 3. fi02 ≤ 30%

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 88 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2017-10-25

Participant Flow

Three university-affiliated tertiary NICUs recruited patients between March 2013 and December 2015. 560 patients were screening for eligibility.

One patient in the Curosurf group was found to have an exclusion criteria after randomization and was excluded (he did not receive the assigned treatment).

Participant milestones

Measure	Curosurf (Group 1) Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.	BLES (Group 2) Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
Overall Study STARTED	43	45
Overall Study COMPLETED	42	45
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Curosurf (Group 1) Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.	BLES (Group 2) Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
Overall Study Protocol Violation	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Curosurf (Group 1) n=42 Participants Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study. Curosurf-Group1: Maximum of 3 doses are administered to infants diagnosed with RDS.	BLES (Group 2) n=45 Participants Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study. BLES-group 2: Maximum of 3 doses are administered to infants with RDS	Total n=87 Participants Total of all reporting groups
Age, Continuous	26.5 weeks gestational age STANDARD_DEVIATION 1.5 • n=42 Participants	26.9 weeks gestational age STANDARD_DEVIATION 2.1 • n=45 Participants	26.7 weeks gestational age STANDARD_DEVIATION 1.9 • n=87 Participants
Sex: Female, Male Female	23 Participants n=42 Participants	12 Participants n=45 Participants	35 Participants n=87 Participants
Sex: Female, Male Male	19 Participants n=42 Participants	33 Participants n=45 Participants	52 Participants n=87 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	42 participants n=42 Participants	45 participants n=45 Participants	87 participants n=87 Participants
fraction of inspired oxygen	45 % of inspired oxygen n=42 Participants	45 % of inspired oxygen n=45 Participants	45 % of inspired oxygen n=87 Participants

PRIMARY outcome

Timeframe: 48 hours

1. rate on ventilator ≤40 per minute and

2. mean airway pressure ≤ 10 cm H20 and

3. fi02 ≤ 30%

Outcome measures

Measure	Curosurf (Group 1) n=42 Participants Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.	BLES (Group 2) n=45 Participants Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation	21 Participants	26 Participants

SECONDARY outcome

Timeframe: 36 weeks GA

1. Extubation failure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 weeks GA

2. Duration of first intubation (in hours/days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 weeks GA

3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 weeks GA

4. Number of doses of surfactant received

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 weeks GA

5. Adverse events during or after administration of surfactant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 Weeks GA

6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 weeks GA

7. Mortality prior to discharge

Outcome measures

Outcome data not reported

Adverse Events

Curosurf (Group 1)

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

BLES (Group 2)

Serious events: 11 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Curosurf (Group 1) n=42 participants at risk Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.	BLES (Group 2) n=45 participants at risk Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
Respiratory, thoracic and mediastinal disorders severe airway obstruction	0.00% 0/42	11.1% 5/45 • Number of events 5
Reproductive system and breast disorders air leak	7.1% 3/42 • Number of events 3	11.1% 5/45 • Number of events 5
Respiratory, thoracic and mediastinal disorders pulmonary hemorrhage	4.8% 2/42 • Number of events 2	6.7% 3/45 • Number of events 3
Cardiac disorders needing CPR	0.00% 0/42	4.4% 2/45 • Number of events 2

Other adverse events

Measure	Curosurf (Group 1) n=42 participants at risk Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.	BLES (Group 2) n=45 participants at risk Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.
Respiratory, thoracic and mediastinal disorders pulmonary interstitial emphysema	2.4% 1/42 • Number of events 1	2.2% 1/45 • Number of events 1

Additional Information

Dr. Brigitte Lemyre

OHRI

Phone: 613-737-8899

Email: blemyre@toh.on.ca

Results disclosure agreements

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