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Childhood Adenotonsillectomy Study for Children With OSAS (CHAT)

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ClinicalTrials.gov Identifier: NCT00560859
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
Harvard University
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Obstructive Sleep Apnea
Snoring
Interventions Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils
Other: Watchful Waiting
Enrollment 453
Recruitment Details Children were recruited at 7 academic sleep centers. Early in the trial the investigator at one center relocated and that center was withdrawn.
Pre-assignment Details  
Arm/Group Title Early AT Surgery Watchful Waiting
Hide Arm/Group Description

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Period Title: Overall Study
Started 226 227
Completed 194 203
Not Completed 32 24
Arm/Group Title Early AT Surgery Watchful Waiting Total
Hide Arm/Group Description

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Total of all reporting groups
Overall Number of Baseline Participants 226 227 453
Hide Baseline Analysis Population Description
These numbers represent all children randomized .
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 226 participants 227 participants 453 participants
6.6  (1.4) 6.5  (1.4) 6.6  (1.4)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
<=18 years
226
 100.0%
227
 100.0%
453
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
Female
125
  55.3%
109
  48.0%
234
  51.7%
Male
101
  44.7%
118
  52.0%
219
  48.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
American Indian or Alaska Native
1
   0.4%
2
   0.9%
3
   0.7%
Asian
4
   1.8%
3
   1.3%
7
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
126
  55.8%
123
  54.2%
249
  55.0%
White
74
  32.7%
81
  35.7%
155
  34.2%
More than one race
15
   6.6%
12
   5.3%
27
   6.0%
Unknown or Not Reported
6
   2.7%
6
   2.6%
12
   2.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
Hispanic or Latino
16
   7.1%
21
   9.3%
37
   8.2%
Not Hispanic or Latino
210
  92.9%
206
  90.7%
416
  91.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 226 participants 227 participants 453 participants
226 227 453
1.Primary Outcome
Title Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.
Hide Description The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.
Time Frame The primary endpoint measure will occur at 7 months following the baseline visit.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early AT Surgery Watchful Waiting
Hide Arm/Group Description:

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Overall Number of Participants Analyzed 194 203
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.1  (13.9) 5.1  (13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early AT Surgery, Watchful Waiting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference of change from baseline
Estimated Value 2.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months
Hide Description The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.
Time Frame 7 months following the baseline visit.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early AT Surgery Watchful Waiting
Hide Arm/Group Description:

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Overall Number of Participants Analyzed 194 203
Median (Inter-Quartile Range)
Unit of Measure: Events per hour
-3.5
(-7.1 to -1.8)
-1.6
(-3.7 to 0.5)
3.Secondary Outcome
Title Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale
Hide Description Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.
Time Frame 7 months following baseline.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module
Arm/Group Title Early AT Surgery Watchful Waiting
Hide Arm/Group Description:

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Overall Number of Participants Analyzed 194 202
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (0.2) 0  (0.2)
Time Frame Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early AT Surgery Watchful Waiting
Hide Arm/Group Description

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

All-Cause Mortality
Early AT Surgery Watchful Waiting
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Early AT Surgery Watchful Waiting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/226 (3.10%)      9/227 (3.96%)    
Gastrointestinal disorders     
Vomitting *  0/226 (0.00%)  0 1/227 (0.44%)  1
General disorders     
Application site pain *  1/226 (0.44%)  1 1/227 (0.44%)  1
Metabolism and nutrition disorders     
Dehydration *  1/226 (0.44%)  1 0/227 (0.00%)  0
Nervous system disorders     
Hypersomnia *  0/226 (0.00%)  0 1/227 (0.44%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma *  1/226 (0.44%)  1 3/227 (1.32%)  3
Pleural Effusion (non-malignant) *  1/226 (0.44%)  1 0/227 (0.00%)  0
Tonsillar haemorrhage *  3/226 (1.33%)  3 1/227 (0.44%)  1
Sinusitis *  0/226 (0.00%)  0 1/227 (0.44%)  1
Vascular disorders     
Hypertension *  0/226 (0.00%)  0 1/227 (0.44%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early AT Surgery Watchful Waiting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   166/226 (73.45%)      227/227 (100.00%)    
Ear and labyrinth disorders     
Ear Pain *  3/226 (1.33%)  3 2/227 (0.88%)  2
External ear infection *  1/226 (0.44%)  1 0/227 (0.00%)  0
Endocrine disorders     
precocious puberty *  1/226 (0.44%)  1 0/227 (0.00%)  0
Eye disorders     
Conjuctivits *  2/226 (0.88%)  2 1/227 (0.44%)  1
Eye Allergy *  1/226 (0.44%)  1 0/227 (0.00%)  0
Gastrointestinal disorders     
Abdominal Discomfort *  1/226 (0.44%)  1 0/227 (0.00%)  0
Breath Odor *  1/226 (0.44%)  1 0/227 (0.00%)  0
Constipation *  1/226 (0.44%)  1 0/227 (0.00%)  0
Dysphagia *  1/226 (0.44%)  1 0/227 (0.00%)  0
gastrooesophageal reflux disease *  2/226 (0.88%)  2 0/227 (0.00%)  0
Nausea *  0/226 (0.00%)  0 1/227 (0.44%)  1
Stomach discomfort *  0/226 (0.00%)  0 2/227 (0.88%)  2
Toothache *  1/226 (0.44%)  1 0/227 (0.00%)  0
Vomitting *  3/226 (1.33%)  3 4/227 (1.76%)  4
General disorders     
Application site bleeding *  1/226 (0.44%)  1 0/227 (0.00%)  0
Application site rash *  1/226 (0.44%)  1 0/227 (0.00%)  0
fatigue *  0/226 (0.00%)  0 1/227 (0.44%)  1
fever (in the absence of neutropenia, where neutropenia is defined as anc <1.0 x 10e9/l) *  0/226 (0.00%)  0 1/227 (0.44%)  1
influenza like illness *  0/226 (0.00%)  0 4/227 (1.76%)  4
pyrexia *  1/226 (0.44%)  1 0/227 (0.00%)  0
Immune system disorders     
Allergy to sting *  0/226 (0.00%)  0 1/227 (0.44%)  1
multiple allergies *  0/226 (0.00%)  0 1/227 (0.44%)  1
Seasonal Allergy *  2/226 (0.88%)  2 4/227 (1.76%)  4
Infections and infestations     
Acute Sinusitis *  3/226 (1.33%)  3 2/227 (0.88%)  2
Adenoviral upper respiratory infection *  1/226 (0.44%)  1 0/227 (0.00%)  0
Bacterial infection *  0/226 (0.00%)  0 1/227 (0.44%)  1
Body Tinea *  1/226 (0.44%)  1 1/227 (0.44%)  1
Bronchitis *  1/226 (0.44%)  1 3/227 (1.32%)  3
Cellulitis *  0/226 (0.00%)  0 1/227 (0.44%)  1
Croup Infectious *  0/226 (0.00%)  0 1/227 (0.44%)  1
Ear Infection *  4/226 (1.77%)  4 8/227 (3.52%)  8
Ear Infection Baceterial *  7/226 (3.10%)  7 4/227 (1.76%)  4
Febrile infection *  2/226 (0.88%)  2 1/227 (0.44%)  1
Fungal infection *  0/226 (0.00%)  0 1/227 (0.44%)  1
Gastroenteritis *  2/226 (0.88%)  2 0/227 (0.00%)  0
Gastroenteritis adenovirus *  0/226 (0.00%)  0 1/227 (0.44%)  1
gastroenteritis viral *  1/226 (0.44%)  1 4/227 (1.76%)  4
Hand-foot-and-mouth disease *  1/226 (0.44%)  1 1/227 (0.44%)  1
hordeolum *  0/226 (0.00%)  0 1/227 (0.44%)  1
infected insect bite *  2/226 (0.88%)  2 1/227 (0.44%)  1
influenza *  2/226 (0.88%)  2 3/227 (1.32%)  3
Lice infestation *  0/226 (0.00%)  0 1/227 (0.44%)  1
Nail Tinea *  1/226 (0.44%)  1 0/227 (0.00%)  0
nasopharyngitis *  0/226 (0.00%)  0 1/227 (0.44%)  1
Otitis media *  6/226 (2.65%)  6 4/227 (1.76%)  4
Otitis media bacterial *  0/226 (0.00%)  0 1/227 (0.44%)  1
Pharyngitis *  4/226 (1.77%)  4 7/227 (3.08%)  7
pharyngitis streptococcal *  2/226 (0.88%)  2 5/227 (2.20%)  5
pneumonia *  4/226 (1.77%)  4 2/227 (0.88%)  2
pneumonia mycoplasmal *  1/226 (0.44%)  1 1/227 (0.44%)  1
relapsing fever *  1/226 (0.44%)  1 0/227 (0.00%)  0
Rhinitis *  0/226 (0.00%)  0 2/227 (0.88%)  2
Rhinovirus infection *  0/226 (0.00%)  0 1/227 (0.44%)  1
Scarlet Fever *  0/226 (0.00%)  0 2/227 (0.88%)  2
Sinusitis *  1/226 (0.44%)  1 0/227 (0.00%)  0
Sinusitis bacterial *  0/226 (0.00%)  0 1/227 (0.44%)  1
Staphylococcal skin infection *  1/226 (0.44%)  1 0/227 (0.00%)  0
Streptococcal bacteraemia *  4/226 (1.77%)  4 6/227 (2.64%)  6
Streptococcal infection *  3/226 (1.33%)  3 8/227 (3.52%)  8
Sweating fever *  2/226 (0.88%)  2 1/227 (0.44%)  1
Tinea infection *  1/226 (0.44%)  1 0/227 (0.00%)  0
Tonsillitis *  0/226 (0.00%)  0 2/227 (0.88%)  2
Tonsillitis streptococcal *  0/226 (0.00%)  0 2/227 (0.88%)  2
Tooth Infection *  0/226 (0.00%)  0 1/227 (0.44%)  1
Upper respiratory tract infection *  6/226 (2.65%)  6 3/227 (1.32%)  3
Urinary tract infection *  1/226 (0.44%)  1 4/227 (1.76%)  4
Varicella *  0/226 (0.00%)  0 1/227 (0.44%)  1
Viral Infection *  1/226 (0.44%)  1 2/227 (0.88%)  2
Viral Rash *  1/226 (0.44%)  1 0/227 (0.00%)  0
Viral Sinusitis *  1/226 (0.44%)  1 0/227 (0.00%)  0
Viral Upper Respiratory tract infection *  1/226 (0.44%)  1 0/227 (0.00%)  0
Injury, poisoning and procedural complications     
Animal Bite *  0/226 (0.00%)  0 1/227 (0.44%)  1
Ankle Fracture *  1/226 (0.44%)  1 0/227 (0.00%)  0
Fall *  0/226 (0.00%)  0 1/227 (0.44%)  1
Foreign body in eye *  0/226 (0.00%)  0 1/227 (0.44%)  1
hand fracture *  1/226 (0.44%)  1 1/227 (0.44%)  1
head injury *  1/226 (0.44%)  1 0/227 (0.00%)  0
incision site pain *  2/226 (0.88%)  2 0/227 (0.00%)  0
infection with unknown anc - bladder (urinary) *  0/226 (0.00%)  0 1/227 (0.44%)  1
laceration *  0/226 (0.00%)  0 2/227 (0.88%)  2
muscle injury *  2/226 (0.88%)  2 0/227 (0.00%)  0
nasal cavity/paranasal sinus reactions *  0/226 (0.00%)  0 2/227 (0.88%)  2
post procedural complication *  1/226 (0.44%)  1 0/227 (0.00%)  0
postoperative fever *  1/226 (0.44%)  1 0/227 (0.00%)  0
road traffic accident *  1/226 (0.44%)  1 0/227 (0.00%)  0
Skin laceration *  0/226 (0.00%)  0 2/227 (0.88%)  2
Wrist fracture *  0/226 (0.00%)  0 1/227 (0.44%)  1
Investigations     
Blood Glucose *  0/226 (0.00%)  0 1/227 (0.44%)  1
electroencephalogram abnormal *  1/226 (0.44%)  1 1/227 (0.44%)  1
Emergency care examination normal *  1/226 (0.44%)  1 0/227 (0.00%)  0
Heart rate irregular *  0/226 (0.00%)  0 1/227 (0.44%)  1
Tympanometry *  0/226 (0.00%)  0 1/227 (0.44%)  1
Metabolism and nutrition disorders     
Dehydration *  3/226 (1.33%)  3 1/227 (0.44%)  1
Diabetes Mellitus non-insulin dependent *  1/226 (0.44%)  1 0/227 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Growing pains *  1/226 (0.44%)  1 0/227 (0.00%)  0
neck pain *  0/226 (0.00%)  0 1/227 (0.44%)  1
Torticollis *  0/226 (0.00%)  0 1/227 (0.44%)  1
Nervous system disorders     
Dizziness *  0/226 (0.00%)  0 1/227 (0.44%)  1
headache *  1/226 (0.44%)  1 6/227 (2.64%)  6
hypersomnia *  1/226 (0.44%)  1 0/227 (0.00%)  0
loss of consciousness *  1/226 (0.44%)  1 0/227 (0.00%)  0
Sinus headache *  0/226 (0.00%)  0 1/227 (0.44%)  1
Somnolence *  0/226 (0.00%)  0 1/227 (0.44%)  1
Syncope *  0/226 (0.00%)  0 1/227 (0.44%)  1
Psychiatric disorders     
Attention Deficit/Hyperactivitiy disorder *  3/226 (1.33%)  3 4/227 (1.76%)  4
Renal and urinary disorders     
Enuresis *  0/226 (0.00%)  0 1/227 (0.44%)  1
Urinary tract pain *  0/226 (0.00%)  0 1/227 (0.44%)  1
Reproductive system and breast disorders     
genital rash *  0/226 (0.00%)  0 1/227 (0.44%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic cough *  1/226 (0.44%)  1 1/227 (0.44%)  1
Allergic rhinitis *  0/226 (0.00%)  0 1/227 (0.44%)  1
Asthma *  2/226 (0.88%)  2 14/227 (6.17%)  14
Asthmatic crisis *  0/226 (0.00%)  0 1/227 (0.44%)  1
Choking sensation *  1/226 (0.44%)  1 0/227 (0.00%)  0
Cough *  15/226 (6.64%)  15 11/227 (4.85%)  11
Croup Non infectious *  1/226 (0.44%)  1 0/227 (0.00%)  0
Epistaxis *  2/226 (0.88%)  2 4/227 (1.76%)  4
nasal congestion *  10/226 (4.42%)  10 10/227 (4.41%)  10
postnasal drip *  1/226 (0.44%)  1 0/227 (0.00%)  0
productive cough *  1/226 (0.44%)  1 0/227 (0.00%)  0
pulmonary congestion *  1/226 (0.44%)  1 0/227 (0.00%)  0
Rhinitis seasonal *  0/226 (0.00%)  0 2/227 (0.88%)  2
Rhinorrhoea *  0/226 (0.00%)  0 1/227 (0.44%)  1
Sinus congestion *  1/226 (0.44%)  1 1/227 (0.44%)  1
Sleep Apnea *  0/226 (0.00%)  0 5/227 (2.20%)  5
Snoring *  0/226 (0.00%)  0 1/227 (0.44%)  1
Throat irritation *  3/226 (1.33%)  3 5/227 (2.20%)  5
Tonsillar haemorrhage *  1/226 (0.44%)  1 1/227 (0.44%)  1
Upper respiratory tract congestion *  3/226 (1.33%)  3 10/227 (4.41%)  10
Upper respiratory tract inflammation *  1/226 (0.44%)  1 2/227 (0.88%)  2
vasomotor rhinitis *  1/226 (0.44%)  1 0/227 (0.00%)  0
Wheezing *  1/226 (0.44%)  1 3/227 (1.32%)  3
Skin and subcutaneous tissue disorders     
Dermatitis *  1/226 (0.44%)  1 0/227 (0.00%)  0
rash *  2/226 (0.88%)  2 1/227 (0.44%)  1
Social circumstances     
Ear Piercing *  1/226 (0.44%)  1 0/227 (0.00%)  0
Surgical and medical procedures     
Ear Tube removal *  0/226 (0.00%)  0 1/227 (0.44%)  1
Finger nail removal *  0/226 (0.00%)  0 1/227 (0.44%)  1
pain management *  1/226 (0.44%)  1 0/227 (0.00%)  0
Tongue Tie operation *  0/226 (0.00%)  0 1/227 (0.44%)  1
*
Indicates events were collected by non-systematic assessment
Children under 5 years of age, in whom OSAS is common, were not included. Children on medications for ADHD or with prolonged oxygen-hemoglobin desaturation were also excluded, so results cannot be extrapolated to such children.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Susan S. Ellenberg
Organization: University of Pennsylvania
Phone: 215-573-3904
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00560859     History of Changes
Other Study ID Numbers: 804695
5U01HL083129-05 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: July 13, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015