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Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

Primary Purpose

Congenital Heart Disease, Oral Aversion

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endotracheal intubation
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral

Nasal

Arm Description

Infants in this group are endotracheally intubated through their mouth.

Infants in this group are endotracheally intubated through their nose.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 6, 2022
Last Updated
May 13, 2022
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05378685
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Oral Aversion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
The intubation route (oral or nasal) is obvious and visible to everyone who interacts with the infant postoperatively.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral
Arm Type
Active Comparator
Arm Description
Infants in this group are endotracheally intubated through their mouth.
Arm Title
Nasal
Arm Type
Active Comparator
Arm Description
Infants in this group are endotracheally intubated through their nose.
Intervention Type
Procedure
Intervention Name(s)
Endotracheal intubation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feeding method at discharge
Description
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).
Time Frame
Approximately 1 month after surgery
Secondary Outcome Measure Information:
Title
Time to full feeds
Description
Infants are assessed for the time to progress to the following feeding milestones: speech pathologist assessment, speech pathologist clearance, NG tube removal, discharge home.
Time Frame
Approximately 1 month after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Yildirim, MD
Organizational Affiliation
UVA Pediatric Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22421593
Citation
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.
Results Reference
background
PubMed Identifier
26957404
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.
Results Reference
background
PubMed Identifier
18377449
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.
Results Reference
background
PubMed Identifier
29432890
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.
Results Reference
background
PubMed Identifier
16235279
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. doi: 10.1002/14651858.CD001071.pub2.
Results Reference
background
PubMed Identifier
28033074
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.
Results Reference
background
PubMed Identifier
16256781
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.
Results Reference
background
PubMed Identifier
10796391
Citation
Spence K, Barr P. Nasal versus oral intubation for mechanical ventilation of newborn infants. Cochrane Database Syst Rev. 2000;1999(2):CD000948. doi: 10.1002/14651858.CD000948.
Results Reference
background
PubMed Identifier
17300297
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. doi: 10.1111/j.1365-2044.2007.04939.x.
Results Reference
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Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

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