Congenital Heart DiseasePhase 2NCT02492269

Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study

A Phase 2 study testing Dexmedetomidine in people with Congenital Heart Disease, run by Aymen N Naguib at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 month to 12 months
Conditions the study is for: Congenital Heart Disease
What is being tested?: Dexmedetomidine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: May 2014to Dec 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 month to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

Patients with the following diagnosis:
ASD
VSD
AVSD
TOF
Biventricular repair with left to right shunt.

Who cannot join

Patients with the diagnosis of AVSD and pulmonary hypertension
Patients less than 1 year and require any of the following repairs:
HLHS
Aortic arch reconstruction
Arterial switch
TOF with pulmonary atresia

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.

Conditions: Congenital Heart Disease
Being tested: Dexmedetomidine, Placebo
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.

DexmedetomidineDrug
Also called Precedex
PlaceboDrug
Also called normal saline

Study groups in NCT02492269
Study group	Role	What they receive
Dexmedetomidine	Experimental	Dexmedetomidine in addition to 15 µg/kg of fentanyl Receives: Drug: Dexmedetomidine
Placebo	Placebo comparator	Normal saline as a placebo in addition to 15 µg/kg of fentanyl Receives: Drug: Placebo

What is being measured

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

Change in Cytokine Levels
Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Measured: From baseline to 24 hrs post-op
Change in Hormone Levels
ACTH, cortisol, epinephrine, \& norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Measured: From baseline to 24 hrs post-op
Change in Bayley Cognitive Composite Scores
Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.
Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.
Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Measured: From baseline to 1 year post-op

Secondary outcomes (2)

Change in Bayley Language Composite Scores
Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.
Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.
Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Measured: From baseline to 1 year post-op
Change in Bayley Motor Composite Scores
Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.
Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.
Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Measured: From baseline to 1 year post-op

Timeline

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

May 2014Dec 2024

First posted8 Jul 2015 (estimated)
Study startMay 2014
Primary completionDec 2024
Study completionDec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02492269
Sponsor's protocol ID: IRB13-00088
Status last verified: Jul 2025
First submitted: 3 Jul 2015
Last updated: 7 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Congenital Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
ClinicalTrials.gov ID: NCT02492269
Acronym / sponsor ID: IRB13-00088
Conditions: Congenital Heart Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Aymen N NaguibUniversity, hospital or other
Study start: May 2014
Primary completion: Dec 2024 (actual)
Study completion: Dec 2024 (actual)
First posted: 8 Jul 2015 (estimated)
Results: Posted 7 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine	Experimental	Drug: DexmedetomidineDexmedetomidine in addition to 15 µg/kg of fentanyl
Placebo	Placebo comparator	Drug: PlaceboNormal saline as a placebo in addition to 15 µg/kg of fentanyl

Who may qualify

Ages: 1 month to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Patients with the following diagnosis:

Key exclusion criteria (6 listed)

Patients with the diagnosis of AVSD and pulmonary hypertension
Patients less than 1 year and require any of the following repairs:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineAlso: Precedex	Drug	Dexmedetomidine
PlaceboAlso: normal saline	Drug	Placebo

Primary outcome

Change in Cytokine Levels
Time frame: From baseline to 24 hrs post-op
Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Change in Hormone Levels
Time frame: From baseline to 24 hrs post-op
ACTH, cortisol, epinephrine, \& norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Change in Bayley Cognitive Composite Scores
Time frame: From baseline to 1 year post-op
Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.

2 secondary outcomes

Change in Bayley Language Composite Scores
Time frame: From baseline to 1 year post-op
Change in Bayley Motor Composite Scores
Time frame: From baseline to 1 year post-op

Results and safety

Results posted to the registry on 7 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexmedetomidine	14	14
Placebo	16	16

Primary outcome: Change in Cytokine Levels

Time frame: From baseline to 24 hrs post-op. Mean (Standard Deviation). Unit: picograms per milliliter

Measure	Dexmedetomidine n = 14	Placebo n = 16
Baseline TNF-alpha	4.38 (1.63)	4.2 (2.55)
Post-sternotomy TNF-alpha	3.98 (1.58)	3.85 (2.37)
Post-bypass TNF-alpha	2.88 (1.14)	2.72 (1.76)
End of surgery TNF-alpha	3.12 (1.94)	2.96 (1.7)
24 hr. post-op TNF-alph	2.68 (1.25)	3.30 (2.43)
Baseline IL-6	0.57 (0.71)	0.96 (1.59)
Post-sternotomy IL-6	0.61 (0.53)	0.99 (1.29)
Post-bypass IL-6	0.87 (0.59)	1.19 (1.3)

Primary outcome: Change in Hormone Levels

Time frame: From baseline to 24 hrs post-op. Mean (Standard Deviation). Unit: picograms per milliliter

Measure	Dexmedetomidine n = 14	Placebo n = 16
Baseline ACTH	150.10 (119.78)	139.48 (96.11)
Post-sternotomy ACTH	105.63 (141.15)	94.2 (93.8)
Post-bypass ACTH	108.09 (114.86)	199.34 (160.34)
End of surgery ACTH	186.69 (170.06)	201.49 (171.01)
24 hr. post-op ACTH	18.21 (9.8)	26.78 (19.19)
Baseline Cortisol	448.27 (187.73)	293.92 (138.53)
Post-sternotomy Cortisol	449.71 (144.4)	316.58 (264.12)
Post-bypass Cortisol	314.42 (81.66)	298.64 (217.82)

Primary outcome: Change in Bayley Cognitive Composite Scores

Time frame: From baseline to 1 year post-op. Mean (Standard Deviation). Unit: score on a scale

Measure	Dexmedetomidine n = 14	Placebo n = 16
Baseline	102.14 (11.04)	95 (16.12)
Prior to discharge	102.14 (13.26)	88.33 (17.49)
1-3 month post-op	102.86 (14.9)	96.82 (17.07)
6 months post-op	98.57 (7.95)	97.27 (16.49)
1 yr. post-op	94.64 (12.0)	94.09 (12.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 hours after surgery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexmedetomidine	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Placebo	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Congenital Heart Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexmedetomidine in people with Congenital Heart Disease, run by Aymen N Naguib 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 7 Aug 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Cytokine Levels (time frame: From baseline to 24 hrs post-op). The study lists 3 primary outcomes in all. 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 NCT02492269.

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 7 Aug 2025.