Trial Outcomes & Findings for Corticosteroids for Children With Febrile Urinary Tract Infections (NCT NCT01391793)

Last Updated: 2019-07-02

Results Overview

Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

546 participants

Primary outcome timeframe

The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Results posted on

2019-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Adjuvant Dexamethasone Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo Placebo: Twice daily for 3 days
Overall Study STARTED	271	275
Overall Study Had a Positive Urine Culture	197	188
Overall Study COMPLETED	124	131
Overall Study NOT COMPLETED	147	144

Reasons for withdrawal

Reasons for withdrawal
Measure	Adjuvant Dexamethasone Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo Placebo: Twice daily for 3 days
Overall Study Ineligible	3	0
Overall Study Urine Culture Negative or Indeterminate	71	87
Overall Study No DMSA	73	57

Baseline Characteristics

Corticosteroids for Children With Febrile Urinary Tract Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adjuvant Dexamethasone n=197 Participants Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo n=188 Participants Placebo: Twice daily for 3 days	Total n=385 Participants Total of all reporting groups
Age, Customized 1-23 months	145 Participants n=5 Participants	132 Participants n=7 Participants	277 Participants n=5 Participants
Age, Customized 24-47 months	39 Participants n=5 Participants	32 Participants n=7 Participants	71 Participants n=5 Participants
Age, Customized 48-71 months	13 Participants n=5 Participants	24 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	171 Participants n=7 Participants	354 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	181 Participants n=5 Participants	175 Participants n=7 Participants	356 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	41 Participants n=5 Participants	28 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) White	128 Participants n=5 Participants	126 Participants n=7 Participants	254 Participants n=5 Participants
Race (NIH/OMB) More than one race	17 Participants n=5 Participants	27 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Study Site Children's Hospital of Pittsburgh, Pittsburgh	185 Participants n=5 Participants	175 Participants n=7 Participants	360 Participants n=5 Participants
Study Site Nationwide Children's Hospital, Columbus	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Study Site American Family Children's Hospital, Madison	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Study Site Children's National Medical Center, D.C.	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Study Site Hasbro Children's Hospital, Providence	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Study Site Primary Children's Hospital, Salt Lake City	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Maternal Education Less than high school	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Maternal Education High school graduate or equivalent	116 Participants n=5 Participants	96 Participants n=7 Participants	212 Participants n=5 Participants
Maternal Education College graduate	66 Participants n=5 Participants	76 Participants n=7 Participants	142 Participants n=5 Participants
Maternal Education Unknown	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Type of Health Insurance Private	81 Participants n=5 Participants	97 Participants n=7 Participants	178 Participants n=5 Participants
Type of Health Insurance Public	108 Participants n=5 Participants	86 Participants n=7 Participants	194 Participants n=5 Participants
Type of Health Insurance None	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Type of Health Insurance Unknown	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Duration of Fever < 48 hours	110 Participants n=5 Participants	96 Participants n=7 Participants	206 Participants n=5 Participants
Duration of Fever >= 48 hours	87 Participants n=5 Participants	92 Participants n=7 Participants	179 Participants n=5 Participants
Ibuprofen Taken in the Past 24 hours No	88 Participants n=5 Participants	83 Participants n=7 Participants	171 Participants n=5 Participants
Ibuprofen Taken in the Past 24 hours Yes	109 Participants n=5 Participants	105 Participants n=7 Participants	214 Participants n=5 Participants
Escherichia Coli Present in Urine Culture No	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Escherichia Coli Present in Urine Culture Yes	187 Participants n=5 Participants	176 Participants n=7 Participants	363 Participants n=5 Participants

PRIMARY outcome

Timeframe: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Population: The analysis was Intent-to-Treat (ITT). The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.

Outcome measures

Outcome measures
Measure	Adjuvant Dexamethasone n=123 Participants Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo n=131 Participants Placebo: Twice daily for 3 days
The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan With scarring	12 Participants	22 Participants
The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Without scarring	111 Participants	109 Participants

PRIMARY outcome

Timeframe: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Population: The analysis was ITT. The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.

Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.

Outcome measures

Outcome measures
Measure	Adjuvant Dexamethasone n=123 Participants Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo n=131 Participants Placebo: Twice daily for 3 days
The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan With severe scarring	0 Participants	3 Participants
The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Without severe scarring	123 Participants	128 Participants

SECONDARY outcome

Timeframe: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For each radiologist, for each child, if either kidney or both kidneys were diagnosed with scarring, then the child was determined to have renal scarring. For each radiologist, the proportion of children with scarring in a given treatment group is the number of children diagnosed with scarring divided by the number of children in the treatment group. The mean proportion of children with scarring in a given treatment group is the average proportion taken across the 3 radiologists.

Outcome measures

Outcome measures
Measure	Adjuvant Dexamethasone n=123 Participants Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo n=131 Participants Placebo: Twice daily for 3 days
The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists	0.127 proportion of participants with scarring Standard Deviation 0.050	0.204 proportion of participants with scarring Standard Deviation 0.046

Adverse Events

Adjuvant Dexamethasone

Serious events: 9 serious events

Other events: 68 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adjuvant Dexamethasone n=271 participants at risk Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo n=275 participants at risk Placebo: Twice daily for 3 days
Gastrointestinal disorders Vomiting	0.00% 0/271 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.36% 1/275 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
General disorders Dehydration	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.73% 2/275 • Number of events 2 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
General disorders Fever unspecified	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.00% 0/275 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
General disorders Fussy infant	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.00% 0/275 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
General disorders Kawasaki's disease	0.00% 0/271 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.36% 1/275 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Infections and infestations Abscess	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.00% 0/275 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Infections and infestations Bacteremia	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.36% 1/275 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Infections and infestations Retropharyngeal abscess	0.00% 0/271 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.36% 1/275 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Metabolism and nutrition disorders Poor weight gain in infact	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.00% 0/275 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Renal and urinary disorders Acute pyelonephritis	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.00% 0/275 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Renal and urinary disorders Posterior urethral values	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.00% 0/275 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Renal and urinary disorders Pyelonephritis	0.00% 0/271 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.73% 2/275 • Number of events 2 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Renal and urinary disorders Urinary tract infection	0.00% 0/271 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.73% 2/275 • Number of events 2 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Skin and subcutaneous tissue disorders Rash; non-specific skin eruption	0.37% 1/271 • Number of events 1 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	0.00% 0/275 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.

Other adverse events

Other adverse events
Measure	Adjuvant Dexamethasone n=271 participants at risk Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days	Placebo n=275 participants at risk Placebo: Twice daily for 3 days
Gastrointestinal disorders Diarrhea	7.0% 19/271 • Number of events 20 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	5.8% 16/275 • Number of events 17 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
General disorders Fever	10.3% 28/271 • Number of events 30 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	9.8% 27/275 • Number of events 33 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
General disorders Fussiness	10.0% 27/271 • Number of events 29 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	3.3% 9/275 • Number of events 9 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Renal and urinary disorders Urinary Tract Infection (UTI) symptoms	3.7% 10/271 • Number of events 11 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.	5.5% 15/275 • Number of events 15 • Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs. Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.

Additional Information

Nader Shaikh, MD, MPH

UPMC Children's Hospital of Pittsburgh

Phone: 412-692-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place