Trial Outcomes & Findings for NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies (NCT NCT03963011)

Last Updated: 2022-01-10

Results Overview

Evaluate the difference between medical and surgical management between study arms. Medical management is defined as subjects whom did not undergo surgery for their NEC diagnosis. Surgical management is defined as subjects that had a surgical intervention for the NEC diagnosis. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

Recruitment status

TERMINATED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

First 12 months

Results posted on

2022-01-10

Participant Flow

Subjects were recruited based on gestational age and were only randomized into Arm A or Arm B upon suspicion of NEC. A total of 56 subjects were enrolled, but only 14 subjects were randomized to Arm A (n=8) or Arm B (n=6)

Participant milestones

Participant milestones
Measure	Arm A: AXR Only Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care	Arm B: AXR + Bowel US Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention Bowel Ultrasound: Ultrasound imaging of the bowel
Overall Study STARTED	8	6
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: AXR Only n=8 Participants Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care	Arm B: AXR + Bowel US n=6 Participants Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention Bowel Ultrasound: Ultrasound imaging of the bowel	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	27.13 Weeks STANDARD_DEVIATION 2.03 • n=93 Participants	26.50 Weeks STANDARD_DEVIATION 3.02 • n=4 Participants	26.62 Weeks STANDARD_DEVIATION 2.64 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	1 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants

PRIMARY outcome

Timeframe: First 12 months

Outcome measures

Outcome measures
Measure	Arm A: AXR Only n=8 Participants Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care	Arm B: AXR + Bowel US n=6 Participants Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention Bowel Ultrasound: Ultrasound imaging of the bowel
Number of Participants Requiring Medical Management	1 participants	1 participants

PRIMARY outcome

Timeframe: 12 months

Population: Only two subjects underwent surgical intervention for their NEC diagnosis. One subject underwent surgery on the same day of diagnosis and the other subject 20 days after diagnosis.

The number of days between NEC diagnosis and surgical intervention for those that need it. Days were continuously counted until subject was discharged from the hospital. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

Outcome measures

Outcome measures
Measure	Arm A: AXR Only Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care	Arm B: AXR + Bowel US n=2 Participants Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention Bowel Ultrasound: Ultrasound imaging of the bowel
Number of Days Between NEC Diagnosis and Surgical Intervention	—	10 Days Interval 0.0 to 20.0

PRIMARY outcome

Timeframe: 12 months

Population: Number of NPO days were evaluated from time of NEC diagnosis to when subject was placed back on continuous feeds.

Number of nothing by mouth (NPO) days between subject diagnosis of NEC to when subject was placed back on continuous feeds. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

Outcome measures

Outcome measures
Measure	Arm A: AXR Only n=8 Participants Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care	Arm B: AXR + Bowel US n=6 Participants Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention Bowel Ultrasound: Ultrasound imaging of the bowel
Number of NPO Days	4 Days Standard Deviation 3.6	7 Days Standard Deviation 1.6

Adverse Events

Arm A: AXR Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B: AXR + Bowel US

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

Erin Opfer, DO

Children's Mercy Hospital

Phone: 816-324-3273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place