Congenital Heart Disease, Oral Aversion
Conditions
Brief summary
Often, infants struggle to feed orally after surgery for congenital heart disease and may require supplemental feeding interventions at discharge. In this study, the investigators prospectively randomize infants to oral or nasal endotracheal intubation for surgery and assess postoperative feeding success.
Detailed description
Patients who require cardiac surgery in the neonatal period frequently encounter difficulties reaching full volume oral feeds. These difficulties are related to developmental features, perioperative events, and post-operative oral aversion symptoms. Patients who struggle with oral feeding require longer hospitalizations and frequently require invasive devices for stable nutrition at discharge. The investigators hypothesize that nasal intubation for neonatal cardiac surgery may reduce time to full oral feeds and decrease the proportion of patients requiring discharge feeding tubes. This is a single-center, prospective randomized control trial of patients less than 2 weeks of age who undergo endotracheal intubation at the time of cardiac surgery. The investigators exclude patients who were \<37 weeks corrected gestational age (GA) at surgery, had orofacial or gastrointestinal anomalies, required \>5 days of intubation before surgery, or required ECMO or \>5 minutes of CPR at any time during the hospitalization. Patients are randomized to nasal (NI) or oral intubation (OI) by a trained pediatric cardiac anesthesiologist at the time of their surgery. Infants are followed post-operatively until the time of discharge and otherwise receive routine care in the intensive care unit and acute cardiology service. Information regarding feeding milestones is obtained from the electronic medical record.
Interventions
PROCEDUREEndotracheal intubation
The patient is intubated using a laryngoscope and cuffed endotracheal tube. The selection and size of the equipment is at the discretion of the pediatric cardiac anesthesiologist.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The intubation route (oral or nasal) is obvious and visible to everyone who interacts with the infant postoperatively.
Intervention model description
Using a random number generator, infants are randomized to oral or nasal intubation by a pediatric cardiac anesthesiologist at the time of surgery. The anesthesiologist may elect to diverge from the randomization based on their clinical judgement and patient safety. Infants are analyzed as treated.
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants who require surgery for congenital heart disease before 2 weeks of age
Exclusion criteria
* \< 37 weeks estimated gestational age at the time of surgery * Orofacial or gastrointestinal anomalies * Devastating neurologic injury or malformation * Intubation \> 5 days prior to surgery * \> 5 minutes of CPR or ECMO at any time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feeding method at discharge | Approximately 1 month after surgery | Infants are discharged home either fed completely by mouth, fed by nasogastric tube (plus/minus some oral feeds), or gastrostomy tube (plus/minus some oral feeds). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to full feeds | Approximately 1 month after surgery | Infants are assessed for the time to progress to the following feeding milestones: speech pathologist assessment, speech pathologist clearance, NG tube removal, discharge home. |
Countries
United States
Outcome results
None listed