Neurodevelopmental AbnormalityNCT04888377
ASPIRIN: Neurodevelopmental Follow-up Trial
An observational study of Neurodevelopmental Abnormality, run by NICHD Global Network for Women's and Children's Health at 14 sites in 6 countries.
Trial summary
A total of 620 children will be enrolled in this study from six sites in sub-Saharan Africa, South Asia, and Latin America. Half of the children's mothers will have taken aspirin and half will have taken placebo. Read more about this study
- Who is it for?
- Ages 33 to 39 monthsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Abnormality
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 666 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 1 Sep 2021to 15 Jun 2022
- 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 33 to 39 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of approximately 620 children, between 33 and 39 months of age, whose mothers were included in the ASPIRIN trial.
Who may be able to join
- Mother was enrolled in the GN ASPIRIN trial
- Mother consented to be recontacted
- Child's parents or guardians are willing and able to give consent
- Child is between 33-39 months of age
- Child does not have significant congenital anomaly (blind or deaf) that would affect them from completing study assessments
- Child does not have other medical conditions that would preclude the child from completing study assessments.
Who cannot join
- The child does not meet the inclusion criteria.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States8 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Boston University
Boston, Massachusetts, 02115
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
University of Colorado Health Sciences Center
Denver, Colorado, 80208
Columbia University
New York, New York, 10032
Christiana Care
Newark, Delaware, 19718
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
RTI International
Research Triangle Park, North Carolina, 27709
India2 sites
Jawaharlal Nehru Medical College
Belagavi
Lata Medical Research Foundation
Nagpur
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
About this study
Official title: Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN): Neurodevelopmental Follow-up Trial
A total of 620 children will be enrolled in this study from six sites in sub-Saharan Africa, South Asia, and Latin America. Half of the children's mothers will have taken aspirin and half will have taken placebo. This will allow the researchers to compare results of the two groups of children and determine if children exposed antenatally to low dose aspirin will have scores on the Bayley Scales of Infant Development-III (BSID-III) examination at 36 months of life (+/-3months) that are not inferior to the child's peers who were not exposed (i.e., by no more than a margin of 4 points).
Read the detailed description
An estimated 250 million children under the age of 511 worldwide are at risk for not achieving their developmental potential; 52.9 million children under five years of age in low- and middle-income country (LMIC) settings have neurodevelopmental delays. Compounding the issue is preterm birth (more common in LMICs) which has consistently been identified as a cause of neurodevelopmental delay. A recent review reported that out of the estimated 13 million preterm infants who survive beyond the first month, 0.9 million will suffer long term neurodevelopmental impairment, with 345,000 moderately or severely affected. This burden places a significant strain on the families, healthcare systems and societies that provide care for these children. Data from other Global Network participating sites (Guatemala, Democratic Republic of Congo, Zambia and Pakistan) also found strikingly high rates of stunting ranging from 44% to 66%, among infants and toddlers. Poverty additionally contributes to the attainment of optimal neurodevelopment. As such, any study of neurodevelopment should at least document these potential confounders.
Aspirin has been shown to predominantly affect both the COX-1 pathway which is involved in thrombosis and the COX-2 pathway, which affects inflammation through the production of Aspirin Triggered Lipoxins. More specifically, aspirin has been shown to inhibit the production of IL-6, IL-1B, CRP and TNF-α all of which have been shown to negatively affect child neurodevelopment and be involved in preeclampsia and preterm birth.
This will be a prospective masked matched cohort study of children between 33 and 39 months (mean 36 months) of age whose mothers were randomized in the ASPIRIN trial *NCT02409680* (1:1 Aspirin-Placebo), who will be evaluated using the BSID-III. Additionally, the Family Resources and Context questionnaire will be performed to adjust for the local context and the ASQ-3 will be administered as a secondary screen. Recognizing the significant role that preterm birth plays in neurodevelopment, the investigators will include 100 (50 in each group) children who were delivered before 37 weeks.
- Conditions
- Neurodevelopmental Abnormality
- Being tested
- Aspirin, Placebo
- Keywords
- Pre-eclampsia, Low Dose Aspirin, ASPIRIN Trail, NICHD Global Network, Global Network, ASPRIN Follow Up, BSID-III, Family Resources and Context, ASQ-36, Neurodevelopmental delays, hypertensive disorders of pregnancy (HDP), Pre-term birth, LDA
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Participant's mothers were administered 81mg of Aspirin throughout their pregnancy with the participant.
PlaceboDrug
Participant's mothers were administered placebo throughout their pregnancy with the participant.
| Study group | Role | What they receive |
|---|---|---|
| Antenatal exposure to low dose aspirin | Mothers in the Global Networks ASPIRIN trial were given 81 mg of Aspirin throughout their pregnancy with the follow-up studies participant. Receives: Drug: Aspirin | |
| Antenatal exposure to Placebo | Mothers in the Global Networks ASPIRIN trial were given placebo throughout their pregnancy with the follow-up studies participant. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score
Mean of the Bayley-III Cognitive Composite Score (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Secondary outcomes (18)
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70
Number of participants with the Bayley-III Cognitive Composite score less than 70 (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the Bayley-III Cognitive Composite score less than 1 SD below the sample mean (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score
Mean of the Bayley-III Language Composite Score (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70
Number of participants with the Bayley-III Language Composite score less than 70 (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the Bayley-III Language Composite score less than 1 SD below the sample mean (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score
Mean of the Bayley-III Motor Composite Score (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 70
Number of participants with the Bayley-III Motor Composite score less than 70 (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the Bayley-III Motor Composite score less than 1 SD below the sample mean (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score
Mean of the ASQ Communication Total Score (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Communication Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score
Mean of the ASQ Gross Motor Total Score (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Gross Motor Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score
Mean of the ASQ Fine Motor Total Score (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Fine Motor Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score
Mean of the ASQ Problem Solving Total Score (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Problem Solving Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score
Mean of the ASQ Personal Social Total Score (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Personal Social Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Measured: At a single visit occurring between 33-39 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Sep 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental AbnormalityStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Thomas Jefferson University, RTI International, Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Elizabeth McClure, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888377
- Sponsor's protocol ID
- GN ASPIRIN Follow Up
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2021
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to release primary results from the study.
Publications
Hoffman MK, Goudar S, Dhaded S, Figueroa L, Mazariegos M, Krebs NF, Westcott J, Tikmani SS, Karim F, Saleem S, Goldenberg RL, Lokangaka A, Tshefu A, Bauserman M, Patel A, Das P, Hibberd P, Chomba E, Mwenchanya M, Carlo WA, Trotta M, Williams A, Moore J, Nolen T, Goco N, McClure EM, Lobo MA, Cunha AB, Derman RJ. Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy. Obstet Gynecol. 2024 Apr 1;143(4):554-561. doi: 10.1097/AOG.0000000000005514. Epub 2024 Jan 23.
PubMed 38262066
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN): Neurodevelopmental Follow-up Trial
- ClinicalTrials.gov ID
- NCT04888377
- Acronym / sponsor ID
- GN ASPIRIN Follow Up
- Conditions
- Neurodevelopmental Abnormality
- Keywords
- Pre-eclampsia, Low Dose Aspirin, ASPIRIN Trail, NICHD Global Network, Global Network, ASPRIN Follow Up, BSID-III, Family Resources and Context
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Thomas Jefferson University, RTI International, Thrasher Research Fund
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 620 children will be enrolled in this study from six sites in sub-Saharan Africa, South Asia, and Latin America. Half of the children's mothers will have taken aspirin and half will have taken placebo. This will allow the researchers to compare results of the two groups of children and determine if children exposed antenatally to low dose aspirin will have scores on the Bayley Scales of Infant Development-III (BSID-III) examination at 36 months of life (+/-3months) that are not inferior to the child's peers who were not exposed (i.e., by no more than a margin of 4 points).
Detailed description
An estimated 250 million children under the age of 511 worldwide are at risk for not achieving their developmental potential; 52.9 million children under five years of age in low- and middle-income country (LMIC) settings have neurodevelopmental delays. Compounding the issue is preterm birth (more common in LMICs) which has consistently been identified as a cause of neurodevelopmental delay. A recent review reported that out of the estimated 13 million preterm infants who survive beyond the first month, 0.9 million will suffer long term neurodevelopmental impairment, with 345,000 moderately or severely affected. This burden places a significant strain on the families, healthcare systems and societies that provide care for these children. Data from other Global Network participating sites (Guatemala, Democratic Republic of Congo, Zambia and Pakistan) also found strikingly high rates of stunting ranging from 44% to 66%, among infants and toddlers. Poverty additionally contributes to the attainment of optimal neurodevelopment. As such, any study of neurodevelopment should at least document these potential confounders.
Aspirin has been shown to predominantly affect both the COX-1 pathway which is involved in thrombosis and the COX-2 pathway, which affects inflammation through the production of Aspirin Triggered Lipoxins. More specifically, aspirin has been shown to inhibit the production of IL-6, IL-1B, CRP and TNF-α all of which have been shown to negatively affect child neurodevelopment and be involved in preeclampsia and preterm birth.
This will be a prospective masked matched cohort study of children between 33 and 39 months (mean 36 months) of age whose mothers were randomized in the ASPIRIN trial *NCT02409680* (1:1 Aspirin-Placebo), who will be evaluated using the BSID-III. Additionally, the Family Resources and Context questionnaire will be performed to adjust for the local context and the ASQ-3 will be administered as a secondary screen. Recognizing the significant role that preterm birth plays in neurodevelopment, the investigators will include 100 (50 in each group) children who were delivered before 37 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal exposure to low dose aspirin | – | Drug: AspirinMothers in the Global Networks ASPIRIN trial were given 81 mg of Aspirin throughout their pregnancy with the follow-up studies participant. |
| Antenatal exposure to Placebo | – | Drug: PlaceboMothers in the Global Networks ASPIRIN trial were given placebo throughout their pregnancy with the follow-up studies participant. |
Who may qualify
- Ages
- 33 to 39 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of approximately 620 children, between 33 and 39 months of age, whose mothers were included in the ASPIRIN trial.
Key inclusion criteria (6 listed)
- Mother was enrolled in the GN ASPIRIN trial
- Mother consented to be recontacted
- Child's parents or guardians are willing and able to give consent
- Child is between 33-39 months of age
- Child does not have significant congenital anomaly (blind or deaf) that would affect them from completing study assessments
Key exclusion criteria (1 listed)
- The child does not meet the inclusion criteria.
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 |
|---|---|---|
| AspirinParticipant's mothers were administered 81mg of Aspirin throughout their pregnancy with the participant. | Drug | Antenatal exposure to low dose aspirin |
| PlaceboParticipant's mothers were administered placebo throughout their pregnancy with the participant. | Drug | Antenatal exposure to Placebo |
Primary outcome
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score
Time frame: At a single visit occurring between 33-39 months corrected age
Mean of the Bayley-III Cognitive Composite Score (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
18 secondary outcomes
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 70
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Time frame: At a single visit occurring between 33-39 months corrected age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38262066Hoffman MK, Goudar S, Dhaded S, Figueroa L, Mazariegos M, Krebs NF, Westcott J, Tikmani SS, Karim F, Saleem S, Goldenberg RL, Lokangaka A, Tshefu A, Bauserman M, Patel A, Das P, Hibberd P, Chomba E, Mwenchanya M, Carlo WA, Trotta M, Williams A, Moore J, Nolen T, Goco N, McClure EM, Lobo MA, Cunha AB, Derman RJ. Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy. Obstet Gynecol. 2024 Apr 1;143(4):554-561. doi: 10.1097/AOG.0000000000005514. Epub 2024 Jan 23.
- Individual participant dataSharing planned: No. The plan is to release primary results from the study.
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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.
Elizabeth McClure, PhD principal investigator
RTI International
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Abnormality, run by NICHD Global Network for Women's and Children's Health at 14 sites in 6 countries.
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 6 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 21 Oct 2024. 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, India, Democratic Republic of the Congo, Guatemala, Pakistan and 1 more country. 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 21 Oct 2024). 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?
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score (time frame: At a single visit occurring between 33-39 months corrected age). 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 NCT04888377, which also lists 1 linked publication.
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 21 Oct 2024.