| Name | Label | Folder | |
|---|---|---|---|
|
itt
Completed study (intention to treat)
|
Completed study (intention to treat) | Administrative/CONSORT Diagram Components | |
|
surgery_status
Patient surgery status
|
Patient surgery status | Administrative/CONSORT Diagram Components | |
|
treated
Has child been treated
|
Has child been treated | Administrative/CONSORT Diagram Components | |
|
treatment_failure
The Medical Monitor confirmed treatment failure?
|
The Medical Monitor confirmed treatment failure? | Administrative/CONSORT Diagram Components | |
|
mat1
Were educational materials provided to the child?
|
Were educational materials provided to the child? | Administrative/Materials Provided | |
|
mat2
Was saline spray provided to the child?
|
Was saline spray provided to the child? | Administrative/Materials Provided | |
|
mat2b
Were directions and application uses reviewed with the parent or guardian?
|
Were directions and application uses reviewed with the parent or guardian? | Administrative/Materials Provided | |
|
pos2
After their adenotonsillectomy, did the child require evaluation in the emergency room (ER)
|
After their adenotonsillectomy, did the child require evaluation in the emergency room (ER) | Administrative/Post-Op Phone Call | |
|
pos2a
If child required evaluation in the emergency room (ER), what was the reason?
|
If child required evaluation in the emergency room (ER), what was the reason? | Administrative/Post-Op Phone Call | |
|
pos3
Did the child have post operative pain requiring pain medication for greater than 3 weeks after surgery?
|
Did the child have post operative pain requiring pain medication for greater than 3 weeks after surgery? | Administrative/Post-Op Phone Call | |
|
pos3a
Has this concern required evaluation or care by a medical professional?
|
Has this concern required evaluation or care by a medical professional? | Administrative/Post-Op Phone Call | |
|
pos4
Are there any current eating or drinking concerns?
|
Are there any current eating or drinking concerns? | Administrative/Post-Op Phone Call | |
|
pos4a
Has this concern required evaluation or care by a medical professional?
|
Has this concern required evaluation or care by a medical professional? | Administrative/Post-Op Phone Call | |
|
pos5
Are there any current concerns about the child's voice?
|
Are there any current concerns about the child's voice? | Administrative/Post-Op Phone Call | |
|
pos5a
Has this concern required evaluation or care by a medical professional?
|
Has this concern required evaluation or care by a medical professional? | Administrative/Post-Op Phone Call | |
|
pos6
Has the breathing or snoring worsened since surgery?
|
Has the breathing or snoring worsened since surgery? | Administrative/Post-Op Phone Call | |
|
pos7
Are there any other major health concerns?
|
Are there any other major health concerns? | Administrative/Post-Op Phone Call | |
|
pos8
Has the child begun any new medications?
|
Has the child begun any new medications? | Administrative/Post-Op Phone Call | |
|
preop1
How was this information obtained?
|
How was this information obtained? | Administrative/Pre-Operative Questionnaire | |
|
preop2
What was the pre-operation Tonsil size?
|
What was the pre-operation Tonsil size? | Administrative/Pre-Operative Questionnaire | |
|
preop3
Is the child a candidate for Adenotonsillectomy?
|
Is the child a candidate for Adenotonsillectomy? | Administrative/Pre-Operative Questionnaire | |
|
preop4
Are there any known contraindications for surgery?
|
Are there any known contraindications for surgery? | Administrative/Pre-Operative Questionnaire | |
|
tonsize
Tonsilar Size
|
Tonsilar Size | Administrative/Pre-Operative Questionnaire | |
|
ran1
Has the participant met all eligibility criteria and signed the consent form; and has the principle investigator reviewed and certified the individual as being eligible?
|
Has the participant met all eligibility criteria and signed the consent form; and has the principle investigator reviewed and certified the individual as being eligible? | Administrative/Randomization | |
|
ran2
Has the participant had an ear, nose, and throat (ENT) evaluation within 90 days of baseline, and is considered a candidate for surgery?
|
Has the participant had an ear, nose, and throat (ENT) evaluation within 90 days of baseline, and is considered a candidate for surgery? | Administrative/Randomization | |
|
ran3
Has the participant had an overnight Polysomnography (PSG) evaluation, and is within the protocol defined limits?
|
Has the participant had an overnight Polysomnography (PSG) evaluation, and is within the protocol defined limits? | Administrative/Randomization | |
|
ran4
Was the child able to perform the neurocognitive testing?
|
Was the child able to perform the neurocognitive testing? | Administrative/Randomization | |
|
ran5
Date the parent signed the consent form
|
Date the parent signed the consent form | Administrative/Randomization | |
|
ran6
Date of randomization
|
Date of randomization
The original date has been removed as part of deidentification. |
Administrative/Randomization | |
|
ran7
Randomization Code assigned by Data Management System (DMS)
|
Randomization Code assigned by Data Management System (DMS) | Administrative/Randomization | |
|
sst1
Did the participant complete the study, as per protocol?
|
Did the participant complete the study, as per protocol? | Administrative/Study Stop | |
|
sst2
Date the participant stopped
|
Date the participant stopped | Administrative/Study Stop | |
|
sst3
What was the primary reason that the participant stopped?
|
What was the primary reason that the participant stopped? | Administrative/Study Stop | |
|
tst1
Date the participant's treatment stopped
|
Date the participant's treatment stopped | Administrative/Treatment Stop | |
|
tst2
What was the primary reason that the participant's treatment was stopped?
|
What was the primary reason that the participant's treatment was stopped? | Administrative/Treatment Stop | |
|
tst2a
Other medical or neuropsychological necessitated reason, specify
|
Other medical or neuropsychological necessitated reason, specify | Administrative/Treatment Stop | |
|
tst3
Has the Medical Monitor confirmed this to be a treatment failure?
|
Has the Medical Monitor confirmed this to be a treatment failure? | Administrative/Treatment Stop | |
|
tst4
Did this participant crossover?
|
Did this participant crossover? | Administrative/Treatment Stop | |
|
tst4a
If yes, please indicate the primary reason
|
If yes, please indicate the primary reason | Administrative/Treatment Stop | |
|
tst5
Will the participant be continuing with follow-up visits?
|
Will the participant be continuing with follow-up visits? | Administrative/Treatment Stop | |
|
ubl1
Date participant was unblinded
|
Date participant was unblinded | Administrative/Unblinding of Participant | |
|
ubl2
What was the participant's randomization arm?
|
What was the participant's randomization arm? | Administrative/Unblinding of Participant | |
|
ubl3
Why was the participant unblinded?
|
Why was the participant unblinded? | Administrative/Unblinding of Participant | |
|
ubl_pidate
Date
|
Date | Administrative/Unblinding of Participant | |
|
ant1
Date of the current measurements
|
Date of the current measurements | Anthropometry | |
|
ant3_change
Change in height between baseline and follow-up
|
Change in height between baseline and follow-up | Anthropometry | |
|
ant3_gain
Height velocity
|
Height velocity
Change in height between baseline and follow up / number of years between visits |
Anthropometry | |
|
ant4_change
Change in weight between baseline and follow-up
|
Change in weight between baseline and follow-up | Anthropometry | |
|
ant4_gain
Weight velocity
|
Weight velocity
Change in weight between baseline and follow up / number of years between visits |
Anthropometry | |
|
ant5a
Child's Body mass index (BMI) Z-score
|
Child's Body mass index (BMI) Z-score | Anthropometry | |
|
ant5a_chk
Body mass index (BMI) Z-score not required at this visit
|
Body mass index (BMI) Z-score not required at this visit | Anthropometry | |
|
ant61
Neck circumference measurement 1
|
Neck circumference measurement 1 | Anthropometry | |
|
ant62
Neck circumference measurement 2
|
Neck circumference measurement 2 | Anthropometry | |
|
ant63
Neck circumference measurement 3
|
Neck circumference measurement 3 | Anthropometry | |
|
ant64
Neck circumference average
|
Neck circumference average | Anthropometry | |
|
ant71
Waist circumference measurement 1
|
Waist circumference measurement 1 | Anthropometry | |
|
ant72
Waist circumference measurement 2
|
Waist circumference measurement 2 | Anthropometry | |
|
ant73
Waist circumference measurement 3
|
Waist circumference measurement 3 | Anthropometry | |
|
ant74
Waist circumference average
|
Waist circumference average | Anthropometry | |
|
ant81
Hip circumference measurement 1
|
Hip circumference measurement 1 | Anthropometry | |
|
ant82
Hip circumference measurement 2
|
Hip circumference measurement 2 | Anthropometry | |
|
ant83
Hip circumference measurement 3
|
Hip circumference measurement 3 | Anthropometry | |
|
ant84
Hip circumference average
|
Hip circumference average | Anthropometry | |
|
bmi_change
Change in body mass index (BMI) between baseline and follow-up
|
Change in body mass index (BMI) between baseline and follow-up | Anthropometry | |
|
bmi_gain
Body mass index (BMI) velocity
|
Body mass index (BMI) velocity
Change in Body mass index (BMI) between baseline and followup / number of years between visit |
Anthropometry | |
|
bmipct
Percentile for body mass index (BMI)-for-age
|
Percentile for body mass index (BMI)-for-age | Anthropometry | |
|
bmiz_gain
Body mass index (BMI) velocity
|
Body mass index (BMI) velocity | Anthropometry | |
|
chg_bmiz
Change in body mass index (BMI) Z-score between baseline and follow-up
|
Change in body mass index (BMI) Z-score between baseline and follow-up | Anthropometry | |
|
haz_gain
Height velocity
|
Height velocity | Anthropometry | |
|
obese
BMIPCT greater than or equal to 95 binary
|
BMIPCT greater than or equal to 95 binary | Anthropometry | |
|
overweight
BMIPCT greater than or equal to 85 binary
|
BMIPCT greater than or equal to 85 binary | Anthropometry | |
|
ref8
Child's body mass index (BMI)
|
Child's body mass index (BMI)
Recorded on the Screening Form. Only applicable to non-randomized subjects. |
Anthropometry | |
|
waisthipratio
Waist-hip ratio
|
Waist-hip ratio | Anthropometry | |
|
waz
Z-score for weight-for-age
|
Z-score for weight-for-age | Anthropometry | |
|
waz_gain
Z-score for weight-for-age velocity
|
Z-score for weight-for-age velocity | Anthropometry | |
|
chg_ant1
Time interval between baseline and follow-up
|
Time interval between baseline and follow-up | Anthropometry/CDC Growth Charts | |
|
chg_haz
Z-score for length-for-age change between baseline and follow-up
|
Z-score for length-for-age change between baseline and follow-up | Anthropometry/CDC Growth Charts | |
|
chg_waz
Z-score for weight-for-age change between baseline and follow-up
|
Z-score for weight-for-age change between baseline and follow-up | Anthropometry/CDC Growth Charts | |
|
haz
Z-score for length-for-age or stature-for-age
|
Z-score for length-for-age or stature-for-age | Anthropometry/CDC Growth Charts | |
|
htpct
Percentile for length-for-age or stature-for-age
|
Percentile for length-for-age or stature-for-age | Anthropometry/CDC Growth Charts | |
|
whpct
Percentile for weight-for-length or weight-for-stature
|
Percentile for weight-for-length or weight-for-stature | Anthropometry/CDC Growth Charts | |
|
whz
Z-score for weight-for-length or weight-for-stature
|
Z-score for weight-for-length or weight-for-stature | Anthropometry/CDC Growth Charts | |
|
wtpct
Percentile for weight-for-age
|
Percentile for weight-for-age | Anthropometry/CDC Growth Charts | |
|
avnn
Mean of all normal sinus to normal sinus interbeat intervals (NN)
|
Mean of all normal sinus to normal sinus interbeat intervals (NN) | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
end__sec_
5 minute window end time
|
5 minute window end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event01end
Respiratory event (01) end time
|
Respiratory event (01) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event01start
Respiratory event (01) start time
|
Respiratory event (01) start time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event02end
Respiratory event (02) end time
|
Respiratory event (02) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event02start
Respiratory event (02) start time
|
Respiratory event (02) start time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event03end
Respiratory event (03) end time
|
Respiratory event (03) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event03start
Respiratory event (03) start time
|
Respiratory event (03) start time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event04end
Respiratory event (04) end time
|
Respiratory event (04) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event04start
Respiratory event (04) start time
|
Respiratory event (04) start time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event05end
Respiratory event (05) end time
|
Respiratory event (05) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event05start
Respiratory event (05) start time
|
Respiratory event (05) start time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event06end
Respiratory event (06) end time
|
Respiratory event (06) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event06start
Respiratory event (06) start time
|
Respiratory event (06) start time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event07end
Respiratory event (07) end time
|
Respiratory event (07) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event07start
Respiratory event (07) start time
|
Respiratory event (07) start time | Clinical Data/Diagnostic Studies/Heart Rate Variability | |
|
event08end
Respiratory event (08) end time
|
Respiratory event (08) end time | Clinical Data/Diagnostic Studies/Heart Rate Variability |