Clinical trial NCT05378685: Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery
Official title: The Effect of Oral Versus Nasal Intubation on Feeding Outcomes in Neonates Requiring Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Oral Aversion
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 80
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feeding method at discharge
timeFrame: Approximately 1 month after surgery
Secondary outcomes:
measure: Time to full feeds
timeFrame: Approximately 1 month after surgery
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: UVA Pediatric Intensive Care Unit
name: Melissa Yildirim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Skinner ML, Halstead LA, Rubinstein CS, Atz AM, Andrews D, Bradley SM. Laryngopharyngeal dysfunction after the Norwood procedure. J Thorac Cardiovasc Surg. 2005 Nov;130(5):1293-301. doi: 10.1016/j.jtcvs.2005.07.013. Epub 2005 Oct 13.
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