Trial · NCT02180672

Steroids for Pediatric Apnea Research in Kids

NCT02180672, Phase 3, Completed, Children's Hospital of Philadelphia; results first posted 2021-03-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Steroids for Pediatric Apnea Research in Kids. Trials, record NCT02180672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02180672

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Steroids for Pediatric Apnea Research in Kids
NCT number: NCT02180672
Status: Completed
Phases: Phase 3
Enrollment: 211 participants, actual
Lead sponsor: Children's Hospital of Philadelphia
Conditions: Obstructive Sleep Apnea Syndrome
Interventions: Nasal Fluticasone, Placebo
First posted: 2014-07-03
Last updated: 2021-11-10
Results first posted: 2021-03-10

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Obstructive Apnea Hypopnea Index	3 months	Efficacy measure to assess acute response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome.
Secondary	OAHI	12 months	Efficacy measure to assess duration of response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points.
Secondary	Nasal Obstruction Symptom Evaluation (NOSE)	12 months	Nasal Obstruction Symptom Evaluation (NOSE) scale, a validated scale of nasal obstructive symptoms. The scales ranges from 0-100 with higher values indicating worse nasal obstruction
Secondary	The Epworth Sleepiness Scale	12 months	Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness
Secondary	Pediatric Quality of Life Inventory (PedsQL)	12 month	Pediatric Quality of Life Inventory (PedsQL), a well-validated, generic measure of global quality of life, in which scores range from 0 to 100, with higher scores indicating better quality of life
Secondary	Behavior Rating Inventory of Executive Function (BRIEF)	12 months	Behavior Rating Inventory of Executive Function \[BRIEF\] Global Executive Composite T score, comprising summary measures of behavioral regulation and metacognition \[with mean scores of 50 and standard deviation of 10, with higher scores indicating worse functioning\]
Secondary	Conners Abbreviated Symptom Questionnaire	12 months	A parent-rated measure of symptoms of attention problems, yielding T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning).
Secondary	Purdue Peg Board	12 months	The Purdue Peg Board is a widely used test of fine motor coordination, yields z-scores with a mean of 0 and a standard deviation of 1, with higher scores indicating better performance.
Secondary	Conners Continuous Performance Test (CPT)	12 months	The CPT is a performance measure of sustained attention that yields T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning)
Secondary	Child Behavior Checklist	12-Months	The Child Behavior Checklist (CBCL), is a widely used and validated caregiver-completed survey of behavior competencies that yields standardized, age-adjusted scores on internalizing, externalizing and attentional behavior difficulties81, 82. All scores are T scores with a mean of 50 and standard deviation of 10 (higher scores indicate worse functioning).

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Obstructive Apnea Hypopnea Index	3 months		events per hour	MEAN
SECONDARY	OAHI	12 months	The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome.	events per hour	MEAN
SECONDARY	Nasal Obstruction Symptom Evaluation (NOSE)	12 months		score on a scale	MEAN
SECONDARY	The Epworth Sleepiness Scale	12 months		score on a scale	MEAN
SECONDARY	Pediatric Quality of Life Inventory (PedsQL)	12 month		score on a scale	MEAN
SECONDARY	Behavior Rating Inventory of Executive Function (BRIEF)	12 months		T-Score	MEAN
SECONDARY	Conners Abbreviated Symptom Questionnaire	12 months		T-Score	MEAN
SECONDARY	Purdue Peg Board	12 months		z-Score	MEAN
SECONDARY	Conners Continuous Performance Test (CPT)	12 months		T-Score	MEAN
SECONDARY	Child Behavior Checklist	12-Months		T-Score	MEAN

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Obstructive Apnea Hypopnea Index	Nasal Steroids	7.69	95% Confidence Interval 5.39 to 9.99	events per hour
Obstructive Apnea Hypopnea Index	Placebo	6.33	95% Confidence Interval 4.09 to 8.58	events per hour
OAHI	Nasal Steroids	6.11	95% Confidence Interval 3.97 to 8.24	events per hour
OAHI	Placebo	6.27	95% Confidence Interval 3.98 to 8.55	events per hour
Nasal Obstruction Symptom Evaluation (NOSE)	Nasal Steroids	3.66	95% Confidence Interval 2.54 to 4.77	score on a scale
Nasal Obstruction Symptom Evaluation (NOSE)	Placebo	5.31	95% Confidence Interval 3.43 to 7.2	score on a scale
The Epworth Sleepiness Scale	Nasal Steroids	7.68	95% Confidence Interval 6.24 to 9.12	score on a scale
The Epworth Sleepiness Scale	Placebo	8.56	95% Confidence Interval 6.68 to 10.45	score on a scale
Pediatric Quality of Life Inventory (PedsQL)	Nasal Steroids	78.69	95% Confidence Interval 72.93 to 84.45	score on a scale
Pediatric Quality of Life Inventory (PedsQL)	Placebo	73.67	95% Confidence Interval 66.66 to 80.68	score on a scale

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nasal Steroids	91
Overall Study	STARTED	Placebo	43
Overall Study	COMPLETED	Nasal Steroids	86
Overall Study	COMPLETED	Placebo	36
Overall Study	NOT COMPLETED	Nasal Steroids	5
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Lower Respiratory Tract (Including Asthma)	Respiratory, thoracic and mediastinal disorders	Nasal Steroids	6	86	6
other	Lower Respiratory Tract (Including Asthma)	Respiratory, thoracic and mediastinal disorders	Placebo	9	36	9
other	Upper Respiratory Tract (including cough)	Respiratory, thoracic and mediastinal disorders	Nasal Steroids	37	86	37
other	Upper Respiratory Tract (including cough)	Respiratory, thoracic and mediastinal disorders	Placebo	7	36	7
other	Gastrointestinal Tract	Gastrointestinal disorders	Nasal Steroids	10	86	10
other	Gastrointestinal Tract	Gastrointestinal disorders	Placebo	2	36	2
other	Other Infections	Infections and infestations	Nasal Steroids	8	86	8
other	Other Infections	Infections and infestations	Placebo	3	36	3
other	Sleep Apnea Exacerbation	Respiratory, thoracic and mediastinal disorders	Nasal Steroids	4	86	4
other	Sleep Apnea Exacerbation	Respiratory, thoracic and mediastinal disorders	Placebo	0	36	0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nasal Steroids	66	86
Total, all-cause mortality	Placebo	16	36
Total, other adverse events	Nasal Steroids	66	86
Total, other adverse events	Placebo	16	36
Total, serious adverse events	Nasal Steroids	1	86
Total, serious adverse events	Placebo	0	36

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35779610	DERIVED	PubMed
40051199	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL120909	Utility of nasal steroids for treatment of childhood obstructive sleep apnea	TAPIA, IGNACIO ESTEBAN	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2014 to 2017

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nasal Steroids vs Placebo: deaths from any cause	Trial comparisons
Nasal Steroids vs Placebo: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Continuous Performance Test	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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