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Congenital Heart DiseaseNCT05378685

Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

A study testing Endotracheal intubation in people with Congenital Heart Disease and Oral Aversion, run by University of Virginia at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 2 weeks
Conditions the study is for
Congenital Heart Disease, Oral Aversion
What is being tested?
Endotracheal intubation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Jul 2018to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 2 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants who require surgery for congenital heart disease before 2 weeks of age

Who cannot join

  • < 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Endotracheal intubation
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endotracheal intubationProcedure or surgery

    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.

Study groups in NCT05378685
Study groupRoleWhat they receive
OralActive comparatorInfants in this group are endotracheally intubated through their mouth.
Receives: Procedure: Endotracheal intubation
NasalActive comparatorInfants in this group are endotracheally intubated through their nose.
Receives: Procedure: Endotracheal intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Approximately 1 month after surgery

Secondary outcomes (1)

  1. 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.

    Measured: Approximately 1 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start1 Jul 2018
  3. Primary completion20 Dec 2021
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05378685
Sponsor's protocol ID
20789
Status last verified
May 2022
First submitted
6 May 2022
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22421593

  • 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.

    PubMed 26957404

  • 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.

    PubMed 18377449

  • 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.

    PubMed 29432890

  • 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.

    PubMed 16235279

  • 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.

    PubMed 28033074

  • 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.

    PubMed 16256781

  • 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.

    PubMed 10796391

  • 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.

    PubMed 17300297

  • Yildirim MI, Spaeder MC, Castro BA, Chamberlain R, Fuzy L, Howard S, McNaull P, Raphael J, Sharma R, Vizzini S, Wielar A, Frank DU. The Impact of Nasal Intubation on Feeding Outcomes in Neonates Requiring Cardiac Surgery: A Randomized Control Trial. Pediatr Cardiol. 2024 Feb;45(2):426-432. doi: 10.1007/s00246-023-03322-7. Epub 2023 Oct 18.

    PubMed 37853163

Questions about this trial

What is this clinical trial studying?

A study testing Endotracheal intubation in people with Congenital Heart Disease and Oral Aversion, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feeding method at discharge (time frame: Approximately 1 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05378685, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

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