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NCT05561725 · ClinicalTrials.gov registry record · Phase 4
Perioperative Steroid Dosing on the APR in AIS
A Phase 4 study of Adolescent Idiopathic Scoliosis (AIS), sponsored by Emory University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05561725: Recruiting Phase 4 study of Adolescent Idiopathic Scoliosis (AIS), sponsored by Emory University.
NCT05561725 is a Phase 4 study of Adolescent Idiopathic Scoliosis (AIS) that is actively recruiting participants, run by Emory University. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05561725, a Phase 4 study of Adolescent Idiopathic Scoliosis (AIS), is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion. This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.
Primary Outcome
Laboratory studies to be collected will include c-reactive protein (CRP). Laboratory studies will be performed prior to surgery, post-operatively in the post-anesthesia care unit, and every morning during the in-hospital stay up to 48 hours. Studies will be analyzed in the hospital laboratory using standard sample analysis. No more than 10cc will be collected at each lab draw.
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG Dexamethasone postoperative
Study Locations (1)
Georgia
- Children Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-01-03 |
| Est. Completion | 2026-03 |
| Phase | Phase 4 |
What NCT05561725 shows while recruiting
NCT05561725 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Adolescent Idiopathic Scoliosis (AIS) appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT05561725 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05561725 about?
NCT05561725 is a clinical study titled "Perioperative Steroid Dosing on the APR in AIS". The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexame...
What is the current status of trial NCT05561725?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2023-01-03. Estimated completion is 2026-03.
What conditions does trial NCT05561725 study?
This clinical trial studies the following conditions: Adolescent Idiopathic Scoliosis (AIS).
What interventions are being tested in trial NCT05561725?
The interventions under investigation include: Standard of Care (DRUG), Dexamethasone postoperative (DRUG).
Who is sponsoring clinical trial NCT05561725?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561725 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05561725's enrollment target sits among peer trials
50 1255th of 2000 higher than 679 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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