Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03346850
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

The purpose of the study is to compare two ways (nasogastric tube (NGT) and nasoduodenal tube (NDT)) to provide nutrition to infants admitted to the hospital for viral bronchiolitis and who require high flow nasal cannula therapy.

Condition or Disease	Intervention/Treatment	Phase
Enteral Feeding in Bronchiolitis	Device: Nasogastric tube (NGT) feeding; Device: Nasoduodenal tube (NDT) feeding	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: nasogastric tube (NGT) feeding	Device: Nasogastric tube (NGT) feeding; A nasogastric tube goes from the nose to the stomach.
Active Comparator: nasoduodenal tube (NDT) feeding	Device: Nasoduodenal tube (NDT) feeding; A nasoduodenal tube goes from the nose to the duodenum.

Outcome Measures

Primary Outcome Measures

1. Length of Respiratory Supprt [from the time of hospital admission to discharge (about 6 days)]

Secondary Outcome Measures

1. Number of Participants With Emesis [from the time of hospital admission to discharge (about 6 days)]

2. Peak Respiratory Support in Liters Per Minute [from the time of hospital admission to discharge (about 6 days)]

3. Number of Chest X-rays Obtained Among All Participants [from the time of hospital admission to discharge (about 6 days)]

4. Number of Participants Who Revisited the Emergency Room (ER) [7 days after discharge from hospital]

5. Number of Participants Who Revisited the Emergency Room (ER) [30 days after discharge from hospital]

6. Number of Participants Who Were Readmitted to the Hospital [7 days after discharge from initial hospital visit]

7. Number of Participants Who Were Readmitted to the Hospital [30 days after discharge from initial hospital visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann

Exclusion Criteria:

• Patients with craniofacial abnormalities that prevent tube placement.

• Patients requiring CPAP and mechanical ventilation are also excluded from the study.

• Patients with past surgeries compromising esophageal sphincter tone such as fundoplication or congenital diaphragmatic hernia surgery are excluded.

• Patients transferred to and from PICU are also excluded from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Raymond Parlar-Chun, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 26, 2018

More Information

Publications

None provided.

• Responsible Party: Raymond Parlar-Chun, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03346850
• Other Study ID Numbers: HSC-MS-17-0725
• First Posted: Nov 17, 2017
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Bronchiolitis

Study Results

Participant Flow

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	17
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding	Total
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.	Total of all reporting groups
Overall Participants	20	20	40
Age (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	165 (102)	132 (101)	148.5 (101.5)
Sex: Female, Male (Count of Participants)
Female	10 50%	8 40%	18 45%
Male	10 50%	12 60%	22 55%
Race/Ethnicity, Customized (Count of Participants)
Black	4 20%	4 20%	8 20%
White	2 10%	3 15%	5 12.5%
Other	14 70%	13 65%	27 67.5%
Region of Enrollment (Count of Participants)
United States	20 100%	20 100%	40 100%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	6.8 (2.6)	6.1 (2)	6.45 (2.3)
Number of Participants with Term Gestation (Count of Participants)
Count of Participants [Participants]	13 65%	14 70%	27 67.5%
Number of Participants with Preterm Gestation (Count of Participants)
Count of Participants [Participants]	7 35%	6 30%	13 32.5%
Number of participants with spontaneous vaginal delivery (SVD) (Count of Participants)
Count of Participants [Participants]	14 70%	12 60%	26 65%
Number of participants with cesarean delivery (CD) (Count of Participants)
Count of Participants [Participants]	6 30%	8 40%	14 35%
Number of participants with low risk of aspiration (Count of Participants)
Count of Participants [Participants]	13 65%	14 70%	27 67.5%
Number of participants with high risk of aspiration (Count of Participants)
Count of Participants [Participants]	7 35%	6 30%	13 32.5%

Outcome Measures

1. Primary Outcome

Title	Length of Respiratory Supprt
Time Frame	from the time of hospital admission to discharge (about 6 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	20	20
Mean (Standard Deviation) [hours]	107 (49)	128 (119)

2. Secondary Outcome

Title	Number of Participants With Emesis
Time Frame	from the time of hospital admission to discharge (about 6 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	20	20
Count of Participants [Participants]	6 30%	1 5%

3. Secondary Outcome

Title	Peak Respiratory Support in Liters Per Minute
Time Frame	from the time of hospital admission to discharge (about 6 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	20	20
Mean (Standard Deviation) [liters per minute]	8 (1.6)	7.8 (2.3)

4. Secondary Outcome

Title	Number of Chest X-rays Obtained Among All Participants
Time Frame	from the time of hospital admission to discharge (about 6 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	20	20
Number [chest x-rays]	31	31

5. Secondary Outcome

Title	Number of Participants Who Revisited the Emergency Room (ER)
Time Frame	7 days after discharge from hospital

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	18	17
Count of Participants [Participants]	1 5%	1 5%

6. Secondary Outcome

Title	Number of Participants Who Revisited the Emergency Room (ER)
Time Frame	30 days after discharge from hospital

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	18	17
Count of Participants [Participants]	1 5%	2 10%

7. Secondary Outcome

Title	Number of Participants Who Were Readmitted to the Hospital
Time Frame	7 days after discharge from initial hospital visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	18	17
Count of Participants [Participants]	0 0%	1 5%

8. Secondary Outcome

Title	Number of Participants Who Were Readmitted to the Hospital
Time Frame	30 days after discharge from initial hospital visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Nasogastric Tube (NGT) Feeding	Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.	Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
Measure Participants	18	17
Count of Participants [Participants]	0 0%	1 5%

Adverse Events

Time Frame	From the time of enrollment to discharge (about 6 days)
Arm/Group Title	Nasogastric Tube (NGT) Feeding		Nasoduodenal Tube (NDT) Feeding
Arm/Group Description	Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.		Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.
All Cause Mortality
	Nasogastric Tube (NGT) Feeding		Nasoduodenal Tube (NDT) Feeding
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Nasogastric Tube (NGT) Feeding		Nasoduodenal Tube (NDT) Feeding
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		1/20 (5%)
Respiratory, thoracic and mediastinal disorders
pneumothorax	0/20 (0%)	0	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Nasogastric Tube (NGT) Feeding		Nasoduodenal Tube (NDT) Feeding
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/20 (0%)
General disorders
nose bleed	1/20 (5%)	1	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.