Trial Outcomes & Findings for Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants (NCT NCT00669383)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

Within first 72 hours after birth

Results posted on

2019-02-22

Participant Flow

This randomized trial was conducted at Oregon Health and Science University in Portland, OR and at Sacred Heart Hospital in Pensacola, FL. Subjects were recruited from June 2001 to May 2007.

Women who showed no further signs of preterm delivery after consent were not randomized.

Participant milestones

Participant milestones
Measure	A (Betamethasone) Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	B (Placebo) Placebo dose IM q 24 hours x 2 doses
Overall Study STARTED	44	41
Overall Study COMPLETED	44	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A (Betamethasone) n=44 Participants Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses betamethasone: 12 mg IM q 24 hours x 2 doses	B (Placebo) n=41 Participants Placebo dose IM q 24 hours x 2 doses placebo: Placebo IM q 24 hours x 2 doses	Total n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.9 years STANDARD_DEVIATION 7.5 • n=5 Participants	28.6 years STANDARD_DEVIATION 6.4 • n=7 Participants	27.7 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	41 participants n=7 Participants	85 participants n=5 Participants

PRIMARY outcome

Timeframe: Within first 72 hours after birth

Population: Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.

Outcome measures

Outcome measures
Measure	A (Betamethasone) n=49 Participants Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	B (Placebo) n=49 Participants Placebo dose IM q 24 hours x 2 doses
Measurements of Functional Residual Capacity in Preterm Infants.	24.8 mL/kg Standard Deviation 8.8	22.0 mL/kg Standard Deviation 7.9

PRIMARY outcome

Timeframe: Within first 72 hours after birth

Population: Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.

Outcome measures

Outcome measures
Measure	A (Betamethasone) n=49 Participants Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	B (Placebo) n=49 Participants Placebo dose IM q 24 hours x 2 doses
Measurements of Respiratory Compliance (Crs) in Preterm Infants.	1.21 mL/cm H2O/kg Standard Deviation 0.53	1.01 mL/cm H2O/kg Standard Deviation 0.51

SECONDARY outcome

Timeframe: During initial hospital stay and planned follow-up

Population: Number of participants is greater here as it includes all offspring, including twins.

Outcome measures

Outcome measures
Measure	A (Betamethasone) n=56 Participants Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	B (Placebo) n=56 Participants Placebo dose IM q 24 hours x 2 doses
FiO2 FiO2 greater or equal to 0.30	7 Participants	16 Participants
FiO2 FiO2 greater or equal to 0.40	5 Participants	13 Participants

Adverse Events

A (Betamethasone)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

B (Placebo)

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

Cindy McEvoy, MD

OHSU

Phone: 503-494-0223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place