Trial Outcomes & Findings for Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome (NCT NCT00244101)

NCT ID: NCT00244101

Last Updated: 2023-01-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 648 participants
• Primary outcome timeframe: at 36 weeks postmenstrual age
• Results posted on: 2023-01-18

Participant Flow

Participant milestones

Measure	PS Group Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.	NCPAP Group Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.	ISX Group Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Overall Study STARTED	209	223	216
Overall Study COMPLETED	209	223	216
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome

Baseline characteristics by cohort

Measure	PS Group n=209 Participants Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.	NCPAP Group n=223 Participants Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.	ISX Group n=216 Participants Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.	Total n=648 Participants Total of all reporting groups
Age, Categorical <=18 years	209 Participants n=5 Participants	223 Participants n=7 Participants	216 Participants n=5 Participants	648 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	28.0 weeks of gestation STANDARD_DEVIATION 1.1 • n=5 Participants	28.1 weeks of gestation STANDARD_DEVIATION 1.3 • n=7 Participants	28.1 weeks of gestation STANDARD_DEVIATION 1.1 • n=5 Participants	28.0 weeks of gestation STANDARD_DEVIATION 1.1 • n=4 Participants
Sex: Female, Male Female	118 Participants n=5 Participants	99 Participants n=7 Participants	115 Participants n=5 Participants	332 Participants n=4 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	124 Participants n=7 Participants	101 Participants n=5 Participants	316 Participants n=4 Participants
Region of Enrollment United States	209 participants n=5 Participants	223 participants n=7 Participants	216 participants n=5 Participants	648 participants n=4 Participants

PRIMARY outcome

Timeframe: at 36 weeks postmenstrual age

Population: intention to treat analysis

Outcome measures

Measure	PS Group n=209 Participants Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.	NCPAP Group n=223 Participants Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.	ISX Group n=216 Participants Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Death or Chronic Lung Disease	76 participants	68 participants	62 participants

PRIMARY outcome

Timeframe: 36 weeks adjusted age

Outcome measures

Measure	PS Group n=209 Participants Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.	NCPAP Group n=223 Participants Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.	ISX Group n=216 Participants Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Death	15 Participants	9 Participants	15 Participants

Adverse Events

Prophylactic Surfactant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surfactant Extubated to nCPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NCPAP

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

Roger F. Soll, MD

Vermont Oxford Network

Phone: 802 865 4814

Email: roger.soll@uvmhealth.org

Results disclosure agreements

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