Anemia, Sickle CellNCT00890396

Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)

An observational study of Anemia, Sickle Cell, run by National Heart, Lung, and Blood Institute (NHLBI) at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 7 years
Conditions the study is for: Anemia, Sickle Cell
What is being tested?: Hydroxyurea
How many people: 163 participants
Where: 14 sitesUnited States
Study dates: Sep 2008to Dec 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 7 years
All sexes
No healthy volunteers
Child

Study population: Children from the initial BABY HUG study who agree to participate in this follow-up study.

Who may be able to join

All children who completed at least 18 months of follow-up visits in the initial BABY HUG study
Children from the initial BABY HUG study who are on a chronic transfusion program or who are recipients of a bone marrow transplant

Who cannot join

Any child who was not enrolled in the initial BABY HUG study for at least 18 months

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Emory University School of Medicine
Atlanta, Georgia, 30342
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Downstate Medical Center
Brooklyn, New York, 11203
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Children's Hospital of Michigan/Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
University of Mississippi Medical Center
Jackson, Mississippi, 39216
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami School of Medicine
Miami, Florida, 33136
Drexel University
Philadelphia, Pennsylvania, 19134
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Howard University College of Medicine
Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Official title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Study

Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in children with SCA. The purpose of this follow-up study is to evaluate the long-term effects of hydroxyurea in children who have participated in the BABY HUG study.

Read the detailed description

SCA is an inherited blood disorder in which the body makes sickle-shaped red blood cells that contain abnormal hemoglobin. The sickled cells block blood flow in the vessels that lead to limbs and organs. This can cause pain, serious infections, and organ damage. The BABY HUG study (NCT00006400) is examining whether the medication hydroxyurea can prevent organ damage, especially in the spleen and kidneys, in children with SCA. This study is a follow-up study to the BABY HUG study and will enroll children who have participated in the BABY HUG study. The purpose of this study is to examine the long-term effects of using hydroxyurea as a treatment for SCA, including both the risks and benefits. Study researchers will also investigate the optimal age to begin treatment with hydroxyurea in children with SCA.

This study will enroll children between 2 and 7 years old who participated in the BABY HUG study. Hydroxyurea will not be provided to participants as part of this study, but participants may receive the medication from their own doctors. Parents of participants can choose for their child to participate in this study in one of two ways-by enrolling in either a passive follow-up group or an active follow-up group. For participants in the passive follow-up group, study researchers will review participants' medical records every 6 months, in addition to reviewing brain ultrasound tests and computed tomography (CT) or magnetic resonance imaging (MRI) scans, if completed. Participants will have a blood and urine collection at baseline and Year 4 (or at the end of the study, whichever comes first). Participants in the active follow-up group will take part in the same study procedures as participants in the passive follow-up group. In addition, at Year 2, participants in this group will undergo an additional blood and urine collection, a scanning procedure to obtain images of the liver and spleen, a kidney test, neuropsychological testing, and an ultrasound imaging test to evaluate liver and spleen size.

Conditions: Anemia, Sickle Cell
Being tested: Hydroxyurea
Keywords: Sickle Cell Anemia, Hydroxyurea
Medical subject headings: Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydroxyureaDrug
Parents and child's doctor may plan to use or not to use hydroxyurea.

Study groups in NCT00890396
Study group	Role	What they receive
Active Follow-up		An active follow-up involved the performance of many of the laboratory tests and procedures done during BABY HUG clinical trials study. These included, but not limited to, serial laboratory parameters that were not part of routine clinical care such as Hgb F levels, pitted cell count, Howell-Jolly Body determination, a liver-spleen scan, diethylenetriaminepentaacetic acid (DTPA) glomerular filtration rate (GFR) measurement, creatinine clearance, Cystatin C, urine concentrating ability, transcranial Doppler, and neuropsychological testing. Receives: Drug: Hydroxyurea
Passive Follow-up		A passive follow-up involved the abstraction of clinical data from the medical record. Results of physical examinations and laboratory tests performed as part of routine clinical care were recorded. Receives: Drug: Hydroxyurea

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes. The change in splenic function (worse vs not-worse) was compared between the randomized treatment groups (hydroxyurea vs placebo). The change in splenic function from baseline to 48 months was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased.
Measured: 48 Months from the date of randomization
Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes.The change in splenic function (worse vs not-worse) was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. The change in splenic function from baseline to 48 months was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased.
Measured: 48 Months from the date of randomization
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
The change in the percentage of pitted cell from randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between the randomized treatment groups (hydroxyurea vs placebo).
Measured: 48 Months from the date of randomization
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
The change in the percentage of pitted cell from randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between the randomized treatment groups (hydroxyurea vs placebo).
Measured: 72 Months from the date of randomization
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
The change in the percentage of pitted cell from the randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.
Measured: 48 Months from the date of randomization
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
The change in the percentage of pitted cell from the randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.
Measured: 72 Months from the date of randomization
Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
The change in Howell-Jolly Bodies from randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between the randomized treatment groups (hydroxyurea vs placebo).
Measured: 48 Months from the date of randomization
Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
The change in Howell-Jolly Bodies from randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between the randomized treatment groups (hydroxyurea vs placebo).
Measured: 72 Months from the date of randomization
Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
The change in Howell-Jolly Bodies from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.
Measured: 48 Months from the date of randomization
Change in Howell-Jolly Bodies From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
The change in Howell-Jolly Bodies (HJB) from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.
Measured: 72 Months from the date of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Dec 2011

First posted29 Apr 2009 (estimated)
Study startSep 2008
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00890396
Sponsor's protocol ID: 647
Other IDs: N01HB07160
Status last verified: Jul 2009
First submitted: 27 Apr 2009
Last updated: 20 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
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RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis

All Anemia, Sickle Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Study
ClinicalTrials.gov ID: NCT00890396
Acronym / sponsor ID: 647
Conditions: Anemia, Sickle Cell
Keywords: Sickle Cell Anemia, Hydroxyurea
Study type: Observational
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
Study start: Sep 2008
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 29 Apr 2009 (estimated)
Results: Posted 20 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Active Follow-up	–	Drug: HydroxyureaAn active follow-up involved the performance of many of the laboratory tests and procedures done during BABY HUG clinical trials study. These included, but not limited to, serial laboratory parameters that were not part of routine clinical care such as Hgb F levels, pitted cell count, Howell-Jolly Body determination, a liver-spleen scan, diethylenetriaminepentaacetic acid (DTPA) glomerular filtration rate (GFR) measurement, creatinine clearance, Cystatin C, urine concentrating ability, transcranial Doppler, and neuropsychological testing.
Passive Follow-up	–	Drug: HydroxyureaA passive follow-up involved the abstraction of clinical data from the medical record. Results of physical examinations and laboratory tests performed as part of routine clinical care were recorded.

Who may qualify

Ages: 2 to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Children from the initial BABY HUG study who agree to participate in this follow-up study.

Key inclusion criteria (2 listed)

All children who completed at least 18 months of follow-up visits in the initial BABY HUG study
Children from the initial BABY HUG study who are on a chronic transfusion program or who are recipients of a bone marrow transplant

Key exclusion criteria (1 listed)

Any child who was not enrolled in the initial BABY HUG study for at least 18 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HydroxyureaParents and child's doctor may plan to use or not to use hydroxyurea.	Drug	Active Follow-up, Passive Follow-up

Primary outcome

Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
Time frame: 48 Months from the date of randomization
The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes. The change in splenic function (worse vs not-worse) was compared between the randomized treatment groups (hydroxyurea vs placebo). The change in splenic function from baseline to 48 months was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased.
Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
Time frame: 48 Months from the date of randomization
The change in splenic function from the randomized control trial baseline measurement was one of the primary outcomes.The change in splenic function (worse vs not-worse) was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit. The change in splenic function from baseline to 48 months was defined as worse if it changed from normal to decreased or absent, or decreased to absent; and not worse if it changed from decreased to decreased, normal to normal, decreased to normal, absent to absent, or absent to decreased.
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
Time frame: 48 Months from the date of randomization
The change in the percentage of pitted cell from randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between the randomized treatment groups (hydroxyurea vs placebo).
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
Time frame: 72 Months from the date of randomization
The change in the percentage of pitted cell from randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between the randomized treatment groups (hydroxyurea vs placebo).
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
Time frame: 48 Months from the date of randomization
The change in the percentage of pitted cell from the randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.
Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
Time frame: 72 Months from the date of randomization
The change in the percentage of pitted cell from the randomized control trial baseline measurement was one of the primary outcomes. The change in the percentage of pitted cell was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.
Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
Time frame: 48 Months from the date of randomization
The change in Howell-Jolly Bodies from randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between the randomized treatment groups (hydroxyurea vs placebo).
Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo
Time frame: 72 Months from the date of randomization
The change in Howell-Jolly Bodies from randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between the randomized treatment groups (hydroxyurea vs placebo).
Change in Howell-Jolly Bodies (HJB) From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
Time frame: 48 Months from the date of randomization
The change in Howell-Jolly Bodies from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.
Change in Howell-Jolly Bodies From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit
Time frame: 72 Months from the date of randomization
The change in Howell-Jolly Bodies (HJB) from the randomized control trial baseline measurement was one of the primary outcomes. The change in Howell-Jolly Bodies was compared between children who were known to be on hydroxyurea vs. off hydroxyurea at the time of the visit.

Results and safety

Results posted to the registry on 20 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	127	122
Passive	36	34

Primary outcome: Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo

Time frame: 48 Months from the date of randomization. Count of participants. Unit: Participants

Measure	Randomized to Hydroxyurea n = 60	Randomized to Placebo n = 49
Splenic function - worse from baseline	16	15
Splenic function - not worse from baseline	44	34

Randomized to Hydroxyurea vs Randomized to Placebo: p = 0.67, Fisher Exact

Population analysed: All subjects who had 48 month and baseline spleen function measurement.

Primary outcome: Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children on Hydroxyurea vs Off Hydroxyurea at Study Visit

Time frame: 48 Months from the date of randomization. Count of participants. Unit: Participants

Measure	On Hydroxyurea at the Time of Visit n = 88	Off Hydroxyurea at the Time of Visit n = 18
Splenic function - worse from baseline	26	5
Splenic function - not worse from baseline	62	13

On Hydroxyurea at the Time of Visit vs Off Hydroxyurea at the Time of Visit: p >0.99, Fisher Exact

Population analysed: All subjects who were known to be on hydroxyurea vs. off hydroxyurea at the 48 month visit, and had 48 month and baseline spleen function measurement.

Primary outcome: Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo

Time frame: 48 Months from the date of randomization. Median (Inter-Quartile Range). Unit: Percentage of pitted cell

Measure	Randomized to Hydroxyurea n = 59	Randomized to Placebo n = 49
Value	-1.70 (-5.70 to 0.00)	-1.00 (-3.40 to -0.10)

Randomized to Hydroxyurea vs Randomized to Placebo: p = 0.61, Kruskal-Wallis

Population analysed: All subjects who had 48 month and baseline pitted cell measurements.

Primary outcome: Change in the Percentage of Pitted Cell From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo

Time frame: 72 Months from the date of randomization. Median (Inter-Quartile Range). Unit: Percentage of pitted cell

Measure	Randomized to Hydroxyurea n = 70	Randomized to Placebo n = 64
Value	-1.55 (-5.70 to -0.30)	-1.40 (-4.75 to -0.35)

Randomized to Hydroxyurea vs Randomized to Placebo: p = 0.78, Kruskal-Wallis

Population analysed: All subjects who had 72 month and baseline pitted cell measurements.

Adverse events

Time frame: The date of consent to follow-up study I (FUS-I) through end of FUS-I, up to 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized to Hydroxyurea	1 of 84 (1.2%)	0 of 84 (0%)	0 of 84
Randomized to Placebo	1 of 79 (1.3%)	0 of 79 (0%)	0 of 79

Limitations and caveats (from the sponsor): Most children used hydroxyurea (HU) for at least part of the FUS-I observation period. This may dilute any effect of randomized group. Most children were on HU at the specified time points, which reduces power to compare on/off HU.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anemia, Sickle Cell

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Assmann, PhD principal investigator

New England Research Institutes, Watertown, MA

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, Sickle Cell, run by National Heart, Lung, and Blood Institute (NHLBI) at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Qualitative Spleen Function From Randomized Control Trial Baseline Measurement - Compared Between Children Randomized to Hydroxyurea vs Placebo (time frame: 48 Months from the date of randomization). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00890396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.