Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

University of Virginia

Status: Unknown

Conditions: Congenital Heart Disease; Oral Aversion

Treatments: Procedure: Endotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT05378685

20789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 2 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Oral

Active Comparator group

Description:

Infants in this group are endotracheally intubated through their mouth.

Treatment:

Procedure: Endotracheal intubation

Nasal

Active Comparator group

Description:

Infants in this group are endotracheally intubated through their nose.

Treatment:

Procedure: Endotracheal intubation