Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

Not Applicable

• Conditions: Congenital Heart Disease; Oral Aversion
• Interventions: Procedure: Endotracheal intubation

• Registration Number: NCT05378685
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2021-12-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-13
• Study First Posted: 2022-05-18
• Last Update Posted: 2022-05-18
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral	Endotracheal intubation	Infants in this group are endotracheally intubated through their mouth.
Nasal	Endotracheal intubation	Infants in this group are endotracheally intubated through their nose.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States