Trial Outcomes & Findings for Sleep Apnea and Fetal Growth Restriction (NCT NCT04084990)

NCT ID: NCT04084990

Last Updated: 2022-03-09

Results Overview

Weight of child at time of birth

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

1 day

Results posted on

2022-03-09

Participant Flow

The study has been terminated due to low enrollment after only 3 participants were randomized. Results will not be analyzed owing to the small number of participants to be randomized to receive aPAP (the intervention) or no aPAP (standard of care treatment).

32 participants provided informed consent to participate. They underwent an obstructive sleep apnea (OSA) risk assessment questionnaire. Those screening as high risk for OSA underwent home sleep apnea testing (HSAT). Those screening as positive on the HSAT, which was defined as an apnea hypopnea index (AHI) \>= 10 OR an AHI \>= 5 with oxygen desaturation index \>= 5, were randomized to receive aPAP or not. Of the 32 participants, only 3 met criteria for enrollment in the randomization phase.

Participant milestones

Participant milestones
Measure	aPAP Nightly use of aPAP when sleeping through the date of delivery S9 VPAP Adapt: Auto-titrated positive airway pressure	No aPAP No use of aPAP (standard of care)
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep Apnea and Fetal Growth Restriction

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 day

Population: Of two mothers randomized to aPAP therapy, one required pre-term induction of labor for maternal safety for preeclampsia with severe features. This fetus experienced in-utero fetal demise, so birth weight was not obtained.

Weight of child at time of birth

Outcome measures

Outcome measures
Measure	aPAP n=1 Participants Nightly use of aPAP when sleeping through the date of delivery S9 VPAP Adapt: Auto-titrated positive airway pressure	No aPAP n=1 Participants No use of aPAP (standard of care)
Birth Weight	2320 grams Interval 2320.0 to 2320.0	570 grams Interval 570.0 to 570.0

SECONDARY outcome

Timeframe: 1 day

Gestational age at delivery

Outcome measures

Outcome measures
Measure	aPAP n=2 Participants Nightly use of aPAP when sleeping through the date of delivery S9 VPAP Adapt: Auto-titrated positive airway pressure	No aPAP n=1 Participants No use of aPAP (standard of care)
Gestational Age at Delivery	31.4 weeks (estimated gestational age) Interval 25.7 to 37.1	25.7 weeks (estimated gestational age) Interval 25.7 to 25.7

Adverse Events

aPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No aPAP

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

Alexander Hincker, Associate Professor of Anesthesiology

Washington University in St. Louis

Phone: 3143231312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	aPAP n=2 Participants Nightly use of aPAP when sleeping through the date of delivery S9 VPAP Adapt: Auto-titrated positive airway pressure	No aPAP n=1 Participants No use of aPAP (standard of care)	Total n=3 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	32.8 Years n=5 Participants	29.8 Years n=7 Participants	31.8 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants