Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

The Effect of Oral Versus Nasal Intubation on Feeding Outcomes in Neonates Requiring Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05378685
• Other study ID #: 20789
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Oral Aversion

Intervention

Procedure:
• Endotracheal 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.

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (9)

Averin K, Uzark K, Beekman RH 3rd, Willging JP, Pratt J, Manning PB. Postoperative assessment of laryngopharyngeal dysfunction in neonates after Norwood operation. Ann Thorac Surg. 2012 Oct;94(4):1257-61. doi: 10.1016/j.athoracsur.2012.01.009. Epub 2012 Mar 14. — View Citation

Hehir DA, Easley RB, Byrnes J. Noncardiac Challenges in the Cardiac ICU: Feeding, Growth and Gastrointestinal Complications, Anticoagulation, and Analgesia. World J Pediatr Congenit Heart Surg. 2016 Mar;7(2):199-209. doi: 10.1177/2150135115615847. Review. — View Citation

Kogon BE, Ramaswamy V, Todd K, Plattner C, Kirshbom PM, Kanter KR, Simsic J. Feeding difficulty in newborns following congenital heart surgery. Congenit Heart Dis. 2007 Sep-Oct;2(5):332-7. doi: 10.1111/j.1747-0803.2007.00121.x. — View Citation

Piggott KD, Babb J, Yong S, Fakioglu H, Blanco C, DeCampli W, Pourmoghadam K. Risk Factors for Gastrostomy Tube Placement in Single Ventricle Patients Following The Norwood Procedure. Semin Thorac Cardiovasc Surg. 2018 Winter;30(4):443-447. doi: 10.1053/j.semtcvs.2018.02.012. Epub 2018 Feb 9. — View Citation

Pinelli J, Symington A. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD001071. Review. Update in: Cochrane Database Syst Rev. 2016 Oct 04;10 :CD001071. — View Citation

Scahill CJ, Graham EM, Atz AM, Bradley SM, Kavarana MN, Zyblewski SC. Preoperative Feeding Neonates With Cardiac Disease. World J Pediatr Congenit Heart Surg. 2017 Jan;8(1):62-68. doi: 10.1177/2150135116668833. — View 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. Epub 2005 Oct 13. — View Citation

Spence K, Barr P. Nasal versus oral intubation for mechanical ventilation of newborn infants. Cochrane Database Syst Rev. 2000;(2):CD000948. Review. — View Citation

Xue FS, Liao X, Liu KP, Liu Y, Xu YC, Yang QY, Li P, Li CW, Sun HT. The circulatory responses to tracheal intubation in children: a comparison of the oral and nasal routes. Anaesthesia. 2007 Mar;62(3):220-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeding method at discharge	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).	Approximately 1 month after surgery
Secondary	Time to full feeds	Infants are assessed for the time to progress to the following feeding milestones: speech pathologist assessment, speech pathologist clearance, NG tube removal, discharge home.	Approximately 1 month after surgery