Enteral Feeding in Bronchiolitis
Conditions
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.
Interventions
DEVICENasogastric tube (NGT) feeding
A nasogastric tube goes from the nose to the stomach.
DEVICENasoduodenal tube (NDT) feeding
A nasoduodenal tube goes from the nose to the duodenum.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Respiratory Supprt | from the time of hospital admission to discharge (about 6 days) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Emesis | from the time of hospital admission to discharge (about 6 days) |
| Peak Respiratory Support in Liters Per Minute | from the time of hospital admission to discharge (about 6 days) |
| Number of Chest X-rays Obtained Among All Participants | from the time of hospital admission to discharge (about 6 days) |
| Number of Participants Who Revisited the Emergency Room (ER) | 7 days after discharge from hospital |
| Number of Participants Who Were Readmitted to the Hospital | 7 days after discharge from initial hospital visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasogastric Tube (NGT) Feeding Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach. | 20 |
| Nasoduodenal Tube (NDT) Feeding Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Nasoduodenal Tube (NDT) Feeding | Nasogastric Tube (NGT) Feeding |
|---|---|---|---|
| Age, Continuous | 148.5 days STANDARD_DEVIATION 101.5 | 132 days STANDARD_DEVIATION 101 | 165 days STANDARD_DEVIATION 102 |
| Number of participants with cesarean delivery (CD) | 14 Participants | 8 Participants | 6 Participants |
| Number of participants with high risk of aspiration | 13 Participants | 6 Participants | 7 Participants |
| Number of participants with low risk of aspiration | 27 Participants | 14 Participants | 13 Participants |
| Number of Participants with Preterm Gestation | 13 Participants | 6 Participants | 7 Participants |
| Number of participants with spontaneous vaginal delivery (SVD) | 26 Participants | 12 Participants | 14 Participants |
| Number of Participants with Term Gestation | 27 Participants | 14 Participants | 13 Participants |
| Race/Ethnicity, Customized Black | 8 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 27 Participants | 13 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 40 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 18 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Male | 22 Participants | 12 Participants | 10 Participants |
| Weight | 6.45 kilograms STANDARD_DEVIATION 2.3 | 6.1 kilograms STANDARD_DEVIATION 2 | 6.8 kilograms STANDARD_DEVIATION 2.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 20 |
Outcome results
Primary
Length of Respiratory Supprt
Time frame: from the time of hospital admission to discharge (about 6 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasogastric Tube (NGT) Feeding | Length of Respiratory Supprt | 107 hours | Standard Deviation 49 |
| Nasoduodenal Tube (NDT) Feeding | Length of Respiratory Supprt | 128 hours | Standard Deviation 119 |
Secondary
Number of Chest X-rays Obtained Among All Participants
Time frame: from the time of hospital admission to discharge (about 6 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nasogastric Tube (NGT) Feeding | Number of Chest X-rays Obtained Among All Participants | 31 chest x-rays |
| Nasoduodenal Tube (NDT) Feeding | Number of Chest X-rays Obtained Among All Participants | 31 chest x-rays |
Secondary
Number of Participants Who Revisited the Emergency Room (ER)
Time frame: 7 days after discharge from hospital
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasogastric Tube (NGT) Feeding | Number of Participants Who Revisited the Emergency Room (ER) | 1 Participants |
| Nasoduodenal Tube (NDT) Feeding | Number of Participants Who Revisited the Emergency Room (ER) | 1 Participants |
Secondary
Number of Participants Who Revisited the Emergency Room (ER)
Time frame: 30 days after discharge from hospital
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasogastric Tube (NGT) Feeding | Number of Participants Who Revisited the Emergency Room (ER) | 1 Participants |
| Nasoduodenal Tube (NDT) Feeding | Number of Participants Who Revisited the Emergency Room (ER) | 2 Participants |
Secondary
Number of Participants Who Were Readmitted to the Hospital
Time frame: 30 days after discharge from initial hospital visit
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasogastric Tube (NGT) Feeding | Number of Participants Who Were Readmitted to the Hospital | 0 Participants |
| Nasoduodenal Tube (NDT) Feeding | Number of Participants Who Were Readmitted to the Hospital | 1 Participants |
Secondary
Number of Participants Who Were Readmitted to the Hospital
Time frame: 7 days after discharge from initial hospital visit
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasogastric Tube (NGT) Feeding | Number of Participants Who Were Readmitted to the Hospital | 0 Participants |
| Nasoduodenal Tube (NDT) Feeding | Number of Participants Who Were Readmitted to the Hospital | 1 Participants |
Secondary
Number of Participants With Emesis
Time frame: from the time of hospital admission to discharge (about 6 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasogastric Tube (NGT) Feeding | Number of Participants With Emesis | 6 Participants |
| Nasoduodenal Tube (NDT) Feeding | Number of Participants With Emesis | 1 Participants |
Secondary
Peak Respiratory Support in Liters Per Minute
Time frame: from the time of hospital admission to discharge (about 6 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasogastric Tube (NGT) Feeding | Peak Respiratory Support in Liters Per Minute | 8 liters per minute | Standard Deviation 1.6 |
| Nasoduodenal Tube (NDT) Feeding | Peak Respiratory Support in Liters Per Minute | 7.8 liters per minute | Standard Deviation 2.3 |