Trial Outcomes & Findings for Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula (NCT NCT03346850)
NCT ID: NCT03346850
Last Updated: 2020-03-25
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
from the time of hospital admission to discharge (about 6 days)
Results posted on
2020-03-25
Participant Flow
Participant milestones
| Measure |
Nasogastric Tube (NGT) Feeding
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
Baseline characteristics by cohort
| Measure |
Nasogastric Tube (NGT) Feeding
n=20 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=20 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
165 days
STANDARD_DEVIATION 102 • n=5 Participants
|
132 days
STANDARD_DEVIATION 101 • n=7 Participants
|
148.5 days
STANDARD_DEVIATION 101.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Weight
|
6.8 kilograms
STANDARD_DEVIATION 2.6 • n=5 Participants
|
6.1 kilograms
STANDARD_DEVIATION 2 • n=7 Participants
|
6.45 kilograms
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Number of Participants with Term Gestation
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Number of Participants with Preterm Gestation
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Number of participants with spontaneous vaginal delivery (SVD)
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Number of participants with cesarean delivery (CD)
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Number of participants with low risk of aspiration
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Number of participants with high risk of aspiration
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from the time of hospital admission to discharge (about 6 days)Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=20 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=20 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Length of Respiratory Supprt
|
107 hours
Standard Deviation 49
|
128 hours
Standard Deviation 119
|
SECONDARY outcome
Timeframe: from the time of hospital admission to discharge (about 6 days)Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=20 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=20 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Number of Participants With Emesis
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from the time of hospital admission to discharge (about 6 days)Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=20 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=20 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Peak Respiratory Support in Liters Per Minute
|
8 liters per minute
Standard Deviation 1.6
|
7.8 liters per minute
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: from the time of hospital admission to discharge (about 6 days)Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=20 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=20 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Number of Chest X-rays Obtained Among All Participants
|
31 chest x-rays
|
31 chest x-rays
|
SECONDARY outcome
Timeframe: 7 days after discharge from hospitalPopulation: 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these participants.
Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=18 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=17 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Number of Participants Who Revisited the Emergency Room (ER)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days after discharge from hospitalPopulation: 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these participants.
Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=18 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=17 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Number of Participants Who Revisited the Emergency Room (ER)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 days after discharge from initial hospital visitPopulation: 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these 5 participants.
Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=18 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=17 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Number of Participants Who Were Readmitted to the Hospital
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days after discharge from initial hospital visitPopulation: 2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these 5 participants.
Outcome measures
| Measure |
Nasogastric Tube (NGT) Feeding
n=18 Participants
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=17 Participants
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Number of Participants Who Were Readmitted to the Hospital
|
0 Participants
|
1 Participants
|
Adverse Events
Nasogastric Tube (NGT) Feeding
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nasoduodenal Tube (NDT) Feeding
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nasogastric Tube (NGT) Feeding
n=20 participants at risk
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=20 participants at risk
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/20 • From the time of enrollment to discharge (about 6 days)
|
5.0%
1/20 • Number of events 1 • From the time of enrollment to discharge (about 6 days)
|
Other adverse events
| Measure |
Nasogastric Tube (NGT) Feeding
n=20 participants at risk
Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.
|
Nasoduodenal Tube (NDT) Feeding
n=20 participants at risk
Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
|
|---|---|---|
|
General disorders
nose bleed
|
5.0%
1/20 • Number of events 1 • From the time of enrollment to discharge (about 6 days)
|
0.00%
0/20 • From the time of enrollment to discharge (about 6 days)
|
Additional Information
Raymond Parlar-Chun, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-5666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place