Trial Outcomes & Findings for Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis (NCT NCT03355326)
NCT ID: NCT03355326
Last Updated: 2021-10-12
Results Overview
time from study start time to goal full feeds by enteral route (per oral (PO), orogastric (OG), gastrostomy tube (gtube)).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
2 months
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
Glycerin Suppository Group
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Glycerin Suppository Group
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
3
|
Baseline Characteristics
one patient did not have silo placed
Baseline characteristics by cohort
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
5.5 days
n=6 Participants
|
4.5 days
n=4 Participants
|
5.0 days
n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
4 participants
n=4 Participants
|
10 participants
n=10 Participants
|
|
Birth weight
|
2.39 kg
n=6 Participants
|
2.53 kg
n=4 Participants
|
2.49 kg
n=10 Participants
|
|
Prenatal gastroschisis diagnosis
|
5 participants
n=6 Participants
|
3 participants
n=4 Participants
|
8 participants
n=10 Participants
|
|
Size of Silo
|
4.0 cm
n=5 Participants • one patient did not have silo placed
|
4.0 cm
n=4 Participants • one patient did not have silo placed
|
4.0 cm
n=9 Participants • one patient did not have silo placed
|
PRIMARY outcome
Timeframe: 2 monthstime from study start time to goal full feeds by enteral route (per oral (PO), orogastric (OG), gastrostomy tube (gtube)).
Outcome measures
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Time to Full Enteral Feeds
|
18.5 days
Interval 14.25 to 22.75
|
17.0 days
Interval 15.25 to 20.0
|
SECONDARY outcome
Timeframe: 1 monthtime from study start time after closure to first bowel movement
Outcome measures
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Time to First Bowel Movement
|
2.5 days
Interval 2.0 to 3.75
|
3.0 days
Interval 1.75 to 4.75
|
SECONDARY outcome
Timeframe: ~3 monthstime from admission (birth) to hospital discharge
Outcome measures
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Hospital Length of Stay
|
26.5 days
Interval 22.5 to 35.25
|
23.5 days
Interval 21.75 to 27.25
|
SECONDARY outcome
Timeframe: 2 monthstotal time that patient required Total Parenteral Nutrition (TPN) feeds
Outcome measures
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Days on Total Parenteral Nutrition (TPN)
|
19.0 days
Interval 16.5 to 23.75
|
20.5 days
Interval 17.25 to 24.25
|
SECONDARY outcome
Timeframe: ~3 monthsAny complications related to TPN administration, including TPN-induced cholestasis and hyperbilirubinemia
Outcome measures
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Number of Participants With Sequela of Long Term Total Parenteral Nutrition (TPN) Administration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: ~3 monthsAny complications related to infections during the admission after start of study; these include infections such as line infections, wound infections, pneumonia, and urinary tract infection (UTI)
Outcome measures
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Number of Participants With Infectious Complications
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: ~3 monthsAny complications during the admission after start of study; these include anything including infections, necrotizing enterocolitis (NEC), small bowel obstruction (SBO), and Total Parenteral Nutrition (TPN)-induced cholestasis.
Outcome measures
| Measure |
Glycerin Suppository Group
n=6 Participants
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 Participants
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Number of Participants With Post-operative Complications
|
2 Participants
|
2 Participants
|
Adverse Events
Glycerin Suppository Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-suppository Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glycerin Suppository Group
n=6 participants at risk
Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
|
Non-suppository Group
n=4 participants at risk
Non-Suppository: No suppository is given beginning after conditions described are met and continued until discontinue conditions are met.
|
|---|---|---|
|
Infections and infestations
Postop infection
|
33.3%
2/6 • through study completion, an average [or up to] 3 months.
|
50.0%
2/4 • through study completion, an average [or up to] 3 months.
|
Additional Information
Dr. Alan Ladd, Principle Investigator
Indiana University, School of Medicine
Phone: 317-274-4606
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place