Trial Outcomes & Findings for Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome (NCT NCT02834624)

Results Overview

Difference between measurement of CRP at baseline and 48 hours after administration of surfactant

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

baseline, 48 hours

Results posted on

2017-06-06

Participant Flow

Infants \< 35 weeks gestation requiring intubation and surfactant for Respiratory Distress Syndrome. Infants with suspected congenital infection, major birth defects, known chromosomal disorder, cord blood pH \< 7.0, or Apgar score of 3 or \< at 10 minutes were excluded. The infants were randomized to receive either Poractant or Calfactant.

Participant milestones

Participant milestones
Measure	Poractant Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.	Calfactant Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Poractant n=15 Participants Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.	Calfactant n=15 Participants Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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
Sex/Gender, Customized Unknown	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 48 hours

Difference between measurement of CRP at baseline and 48 hours after administration of surfactant

Outcome measures

Outcome measures
Measure	Poractant n=15 Participants Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.	Calfactant n=15 Participants Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
Change From Baseline in Blood C-reactive (CRP) Protein	1.300 mg/dL Standard Deviation 1.644	0.193 mg/dL Standard Deviation 0.337

SECONDARY outcome

Timeframe: intraoperative

Population: This data is unavailable from the research department as it was not collected.

Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 48 hours

measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate

Outcome measures

Outcome measures
Measure	Poractant n=15 Participants Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.	Calfactant n=15 Participants Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
Change in Number of Tracheal Macrophages	2.3 white cells/high-powered field Standard Deviation 1.8	2.0 white cells/high-powered field Standard Deviation 1.2

Adverse Events

Calfactant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Poractant Alfa

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Naomi Lauriello

University of Missouri-Columbia

Phone: 573-882-2272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place