Premature InfantNCT03345069
Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
An observational study of Premature Infant, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The Early Prediction Study is a longitudinal population-based cohort study for very preterm infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati and two Dayton area neonatal intensive care units (NICUs) will undergo advanced MRIs at 41 weeks postmenstrual age and… Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Premature Infant
- How many people
- 393 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2016to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: All very preterm infants (≤32 weeks completed gestational age) from a geographically-based population cared for in level III/IV NICUs in Cincinnati/Dayton are eligible. Those with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease will be excluded.
Who may be able to join
- Hospitalized infants born at ≤32 weeks completed gestational age that are being cared for in all three level III/IV NICUs from the Greater Cincinnati area.
Who cannot join
- Infants with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Early Prediction of Cognitive and Motor Deficits Using Advanced MRI in Very Preterm Infants
The Early Prediction Study is a longitudinal population-based cohort study for very preterm infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati and two Dayton area neonatal intensive care units (NICUs) will undergo advanced MRIs at 41 weeks postmenstrual age and neurodevelopmental testing at the corrected ages of two and three years correct age. The goal of the Early Prediction Study is to accurately predict motor, cognitive, and behavioral deficits in individual very preterm infants using neuroimaging technologies and established epidemiologic approaches.
Read the detailed description
With every neonatal intensive care unit discharge, physicians and early intervention specialists face a critical challenge: How to counsel parents about their very preterm infant's risk of developing cognitive and motor deficits and accurately assign early intervention therapies. More than 100,000 babies are born very preterm at ≤32 weeks gestational age every year in the United States. Up to 35% of these preterm survivors develop cognitive deficits, and up to 20% develop motor impairment. This places them at high risk for poor educational, health, and social outcomes. Yet reliable diagnosis of cognitive and motor deficits cannot be made until early childhood. This long and unnecessary delay wastes early intervention resources, dilutes the effectiveness of infant stimulation programs, and disrupts parental adaptation. Attempts to address these gaps with conventional neuroimaging and other approaches have failed. Thus, a critical need exists before neonatal discharge, to accurately predict cognitive and motor deficits in individual very preterm infants with the use of novel neuroimaging technologies and established epidemiologic approaches.
The investigators long-term research goal is to elucidate the etiology, pathogenesis, and early prediction of cognitive and motor deficits in order to facilitate preventive early interventions in very preterm infants, resulting in better outcomes. The investigators objectives in this application therefore are to:
- Identify the clinical antecedents of objectively diagnosed diffuse white matter abnormality (DWMA).
- Associate DWMA with pathologic changes on neuroimaging.
- Predict cognitive and behavioral deficits at 3 years of age using objectively diagnosed DWMA in a geographic cohort of very preterm infants.
- To predict motor impairment, especially cerebral palsy at 24 months corrected age.
The investigators central hypothesis is that objectively quantified DWMA is pathologic, associated with inflammation-associated perinatal illnesses, and an independent predictor of cognitive deficits at 3 years corrected age in very preterm infants. The investigators rationale for this research is that new knowledge investigators expect to have generated will enhance parental counseling, facilitate accurate risk stratification for early intervention therapies, and guide biologically-based strategies for early prevention of DWMA and cognitive and motor deficits in very preterm infants.
- Conditions
- Premature Infant
- Keywords
- Premature, Magnetic resonance imaging (MRI), Neurodevelopmental impairment, Cerebral Palsy, Cognitive Impairment, Diffusion MRI, Functional MRI, Infant, Magnetic resonance spectroscopy
- Medical subject headings
- Premature Birth, Cerebral Palsy, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants born very preterm | This is a single group prospective longitudinal, multisite cohort study of very preterm infants born at or below 32 weeks gestational age at birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor development
Standardized assessment and diagnosis of cerebral palsy at 2 years corrected age
Measured: 2 years of age, corrected for prematurity
Cognitive development
General Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition
Measured: 3 years of age, corrected for prematurity
Behavioral development
Scores on the Child Behavior Checklist \& Early Childhood Behavior Questionnaire - Short Form
Measured: 3 years of age, corrected for prematurity
Secondary outcomes (4)
Cognitive and language deficits at 2years of age
Cognitive and language scores on Bayley Scales of Infant and Toddler Development, 3rd Ed
Measured: 2 years of age, corrected for prematurity
Executive function
Computerized measures of executive function for preschoolers
Measured: 3 years of age, corrected for prematurity
Behavioral development
General Adaptive Composite score on the Adaptive Behavior Assessment System, 2nd Ed.
Measured: 3 years of age, corrected for prematurity
Pre-academic skills
Bracken School Readiness Assessment, 3rd Ed.
Measured: 3 years of age, corrected for prematurity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start16 Sep 2016
- Primary completion31 Dec 2024 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies 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
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati, Good Samaritan Hospital, Ohio, Kettering Health Network, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Nehal A Parikh, DO, MS, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345069
- Sponsor's protocol ID
- CIN_EARLYPREDICTION_001
- Other IDs
- 5R01NS094200, 5R01NS096037
- Status last verified
- Feb 2024
- First submitted
- 8 Nov 2017
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parikh NA. Advanced neuroimaging and its role in predicting neurodevelopmental outcomes in very preterm infants. Semin Perinatol. 2016 Dec;40(8):530-541. doi: 10.1053/j.semperi.2016.09.005. Epub 2016 Nov 15.
PubMed 27863706He L, Li H, Wang J, Chen M, Gozdas E, Dillman JR, Parikh NA. A multi-task, multi-stage deep transfer learning model for early prediction of neurodevelopment in very preterm infants. Sci Rep. 2020 Sep 15;10(1):15072. doi: 10.1038/s41598-020-71914-x.
PubMed 32934282Tamm L, Patel M, Peugh J, Kline-Fath BM, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Group. Early brain abnormalities in infants born very preterm predict under-reactive temperament. Early Hum Dev. 2020 May;144:104985. doi: 10.1016/j.earlhumdev.2020.104985. Epub 2020 Mar 9.
PubMed 32163848Parikh NA, Sharma P, He L, Li H, Altaye M, Priyanka Illapani VS; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Investigators. Perinatal Risk and Protective Factors in the Development of Diffuse White Matter Abnormality on Term-Equivalent Age Magnetic Resonance Imaging in Infants Born Very Preterm. J Pediatr. 2021 Jun;233:58-65.e3. doi: 10.1016/j.jpeds.2020.11.058. Epub 2020 Nov 28.
PubMed 33259857Chandwani R, Kline JE, Harpster K, Tkach J, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Group. Early micro- and macrostructure of sensorimotor tracts and development of cerebral palsy in high risk infants. Hum Brain Mapp. 2021 Oct 1;42(14):4708-4721. doi: 10.1002/hbm.25579. Epub 2021 Jul 29.
PubMed 34322949Chen M, Li H, Fan H, Dillman JR, Wang H, Altaye M, Zhang B, Parikh NA, He L. ConCeptCNN: A novel multi-filter convolutional neural network for the prediction of neurodevelopmental disorders using brain connectome. Med Phys. 2022 May;49(5):3171-3184. doi: 10.1002/mp.15545. Epub 2022 Mar 14.
PubMed 35246986Lal SK, Nath LS. An atypical case of Vogt-Koyanagi syndrome. J Indian Med Assoc. 1986 Dec;84(12):382-3. No abstract available.
PubMed 3585016Jain VG, Kline JE, He L, Kline-Fath BM, Altaye M, Muglia LJ, DeFranco EA, Ambalavanan N, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study Investigators. Acute histologic chorioamnionitis independently and directly increases the risk for brain abnormalities seen on magnetic resonance imaging in very preterm infants. Am J Obstet Gynecol. 2022 Oct;227(4):623.e1-623.e13. doi: 10.1016/j.ajog.2022.05.042. Epub 2022 May 26.
PubMed 35644247Kline JE, Yuan W, Harpster K, Altaye M, Parikh NA. Association between brain structural network efficiency at term-equivalent age and early development of cerebral palsy in very preterm infants. Neuroimage. 2021 Dec 15;245:118688. doi: 10.1016/j.neuroimage.2021.118688. Epub 2021 Nov 7.
PubMed 34758381He L, Li H, Chen M, Wang J, Altaye M, Dillman JR, Parikh NA. Deep Multimodal Learning From MRI and Clinical Data for Early Prediction of Neurodevelopmental Deficits in Very Preterm Infants. Front Neurosci. 2021 Oct 5;15:753033. doi: 10.3389/fnins.2021.753033. eCollection 2021.
PubMed 34675773Chandwani R, Harpster K, Kline JE, Mehta V, Wang H, Merhar SL, Schwartz TL, Parikh NA. Brain microstructural antecedents of visual difficulties in infants born very preterm. Neuroimage Clin. 2022;34:102987. doi: 10.1016/j.nicl.2022.102987. Epub 2022 Mar 9.
PubMed 35290855Kline JE, Illapani VSP, Li H, He L, Yuan W, Parikh NA. Diffuse white matter abnormality in very preterm infants at term reflects reduced brain network efficiency. Neuroimage Clin. 2021;31:102739. doi: 10.1016/j.nicl.2021.102739. Epub 2021 Jun 25.
PubMed 34237685Li H, Chen M, Wang J, Illapani VSP, Parikh NA, He L. Automatic Segmentation of Diffuse White Matter Abnormality on T2-weighted Brain MR Images Using Deep Learning in Very Preterm Infants. Radiol Artif Intell. 2021 Feb 3;3(3):e200166. doi: 10.1148/ryai.2021200166. eCollection 2021 May.
PubMed 34142089Yuan W, Tamm L, Harpster K, Altaye M, Illapani VSP, Parikh NA. Effects of intraventricular hemorrhage on white matter microstructural changes at term and early developmental outcomes in infants born very preterm. Neuroradiology. 2021 Sep;63(9):1549-1561. doi: 10.1007/s00234-021-02708-9. Epub 2021 Apr 8.
PubMed 33830309Harpster K, Merhar S, Priyanka Illapani VS, Peyton C, Kline-Fath B, Parikh NA. Associations Between Early Structural Magnetic Resonance Imaging, Hammersmith Infant Neurological Examination, and General Movements Assessment in Infants Born Very Preterm. J Pediatr. 2021 May;232:80-86.e2. doi: 10.1016/j.jpeds.2020.12.056. Epub 2021 Jan 13.
PubMed 33453201
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Cognitive and Motor Deficits Using Advanced MRI in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT03345069
- Acronym / sponsor ID
- CIN_EARLYPREDICTION_001
- Conditions
- Premature Infant
- Keywords
- Premature, Magnetic resonance imaging (MRI), Neurodevelopmental impairment, Cerebral Palsy, Cognitive Impairment, Diffusion MRI, Functional MRI, Infant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Cincinnati, Good Samaritan Hospital, Ohio, Kettering Health Network, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Early Prediction Study is a longitudinal population-based cohort study for very preterm infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati and two Dayton area neonatal intensive care units (NICUs) will undergo advanced MRIs at 41 weeks postmenstrual age and neurodevelopmental testing at the corrected ages of two and three years correct age. The goal of the Early Prediction Study is to accurately predict motor, cognitive, and behavioral deficits in individual very preterm infants using neuroimaging technologies and established epidemiologic approaches.
Detailed description
With every neonatal intensive care unit discharge, physicians and early intervention specialists face a critical challenge: How to counsel parents about their very preterm infant's risk of developing cognitive and motor deficits and accurately assign early intervention therapies. More than 100,000 babies are born very preterm at ≤32 weeks gestational age every year in the United States. Up to 35% of these preterm survivors develop cognitive deficits, and up to 20% develop motor impairment. This places them at high risk for poor educational, health, and social outcomes. Yet reliable diagnosis of cognitive and motor deficits cannot be made until early childhood. This long and unnecessary delay wastes early intervention resources, dilutes the effectiveness of infant stimulation programs, and disrupts parental adaptation. Attempts to address these gaps with conventional neuroimaging and other approaches have failed. Thus, a critical need exists before neonatal discharge, to accurately predict cognitive and motor deficits in individual very preterm infants with the use of novel neuroimaging technologies and established epidemiologic approaches.
The investigators long-term research goal is to elucidate the etiology, pathogenesis, and early prediction of cognitive and motor deficits in order to facilitate preventive early interventions in very preterm infants, resulting in better outcomes. The investigators objectives in this application therefore are to:
- Identify the clinical antecedents of objectively diagnosed diffuse white matter abnormality (DWMA).
- Associate DWMA with pathologic changes on neuroimaging.
- Predict cognitive and behavioral deficits at 3 years of age using objectively diagnosed DWMA in a geographic cohort of very preterm infants.
- To predict motor impairment, especially cerebral palsy at 24 months corrected age.
The investigators central hypothesis is that objectively quantified DWMA is pathologic, associated with inflammation-associated perinatal illnesses, and an independent predictor of cognitive deficits at 3 years corrected age in very preterm infants. The investigators rationale for this research is that new knowledge investigators expect to have generated will enhance parental counseling, facilitate accurate risk stratification for early intervention therapies, and guide biologically-based strategies for early prevention of DWMA and cognitive and motor deficits in very preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants born very preterm | – | –This is a single group prospective longitudinal, multisite cohort study of very preterm infants born at or below 32 weeks gestational age at birth |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All very preterm infants (≤32 weeks completed gestational age) from a geographically-based population cared for in level III/IV NICUs in Cincinnati/Dayton are eligible. Those with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease will be excluded.
Key inclusion criteria (1 listed)
- Hospitalized infants born at ≤32 weeks completed gestational age that are being cared for in all three level III/IV NICUs from the Greater Cincinnati area.
Key exclusion criteria (1 listed)
- Infants with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor development
Time frame: 2 years of age, corrected for prematurity
Standardized assessment and diagnosis of cerebral palsy at 2 years corrected age
Cognitive development
Time frame: 3 years of age, corrected for prematurity
General Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition
Behavioral development
Time frame: 3 years of age, corrected for prematurity
Scores on the Child Behavior Checklist \& Early Childhood Behavior Questionnaire - Short Form
4 secondary outcomes
Cognitive and language deficits at 2years of age
Time frame: 2 years of age, corrected for prematurity
Executive function
Time frame: 3 years of age, corrected for prematurity
Behavioral development
Time frame: 3 years of age, corrected for prematurity
Pre-academic skills
Time frame: 3 years of age, corrected for prematurity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 27863706Parikh NA. Advanced neuroimaging and its role in predicting neurodevelopmental outcomes in very preterm infants. Semin Perinatol. 2016 Dec;40(8):530-541. doi: 10.1053/j.semperi.2016.09.005. Epub 2016 Nov 15.
- Background: PubMed 32934282He L, Li H, Wang J, Chen M, Gozdas E, Dillman JR, Parikh NA. A multi-task, multi-stage deep transfer learning model for early prediction of neurodevelopment in very preterm infants. Sci Rep. 2020 Sep 15;10(1):15072. doi: 10.1038/s41598-020-71914-x.
- Results publication: PubMed 32163848Tamm L, Patel M, Peugh J, Kline-Fath BM, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Group. Early brain abnormalities in infants born very preterm predict under-reactive temperament. Early Hum Dev. 2020 May;144:104985. doi: 10.1016/j.earlhumdev.2020.104985. Epub 2020 Mar 9.
- Results publication: PubMed 33259857Parikh NA, Sharma P, He L, Li H, Altaye M, Priyanka Illapani VS; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Investigators. Perinatal Risk and Protective Factors in the Development of Diffuse White Matter Abnormality on Term-Equivalent Age Magnetic Resonance Imaging in Infants Born Very Preterm. J Pediatr. 2021 Jun;233:58-65.e3. doi: 10.1016/j.jpeds.2020.11.058. Epub 2020 Nov 28.
- Results publication: PubMed 34322949Chandwani R, Kline JE, Harpster K, Tkach J, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Group. Early micro- and macrostructure of sensorimotor tracts and development of cerebral palsy in high risk infants. Hum Brain Mapp. 2021 Oct 1;42(14):4708-4721. doi: 10.1002/hbm.25579. Epub 2021 Jul 29.
- Results publication: PubMed 35246986Chen M, Li H, Fan H, Dillman JR, Wang H, Altaye M, Zhang B, Parikh NA, He L. ConCeptCNN: A novel multi-filter convolutional neural network for the prediction of neurodevelopmental disorders using brain connectome. Med Phys. 2022 May;49(5):3171-3184. doi: 10.1002/mp.15545. Epub 2022 Mar 14.
- Results publication: PubMed 3585016Lal SK, Nath LS. An atypical case of Vogt-Koyanagi syndrome. J Indian Med Assoc. 1986 Dec;84(12):382-3. No abstract available.
- Results publication: PubMed 35644247Jain VG, Kline JE, He L, Kline-Fath BM, Altaye M, Muglia LJ, DeFranco EA, Ambalavanan N, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study Investigators. Acute histologic chorioamnionitis independently and directly increases the risk for brain abnormalities seen on magnetic resonance imaging in very preterm infants. Am J Obstet Gynecol. 2022 Oct;227(4):623.e1-623.e13. doi: 10.1016/j.ajog.2022.05.042. Epub 2022 May 26.
- Results publication: PubMed 34758381Kline JE, Yuan W, Harpster K, Altaye M, Parikh NA. Association between brain structural network efficiency at term-equivalent age and early development of cerebral palsy in very preterm infants. Neuroimage. 2021 Dec 15;245:118688. doi: 10.1016/j.neuroimage.2021.118688. Epub 2021 Nov 7.
- Results publication: PubMed 34675773He L, Li H, Chen M, Wang J, Altaye M, Dillman JR, Parikh NA. Deep Multimodal Learning From MRI and Clinical Data for Early Prediction of Neurodevelopmental Deficits in Very Preterm Infants. Front Neurosci. 2021 Oct 5;15:753033. doi: 10.3389/fnins.2021.753033. eCollection 2021.
- Results publication: PubMed 35290855Chandwani R, Harpster K, Kline JE, Mehta V, Wang H, Merhar SL, Schwartz TL, Parikh NA. Brain microstructural antecedents of visual difficulties in infants born very preterm. Neuroimage Clin. 2022;34:102987. doi: 10.1016/j.nicl.2022.102987. Epub 2022 Mar 9.
- Results publication: PubMed 34237685Kline JE, Illapani VSP, Li H, He L, Yuan W, Parikh NA. Diffuse white matter abnormality in very preterm infants at term reflects reduced brain network efficiency. Neuroimage Clin. 2021;31:102739. doi: 10.1016/j.nicl.2021.102739. Epub 2021 Jun 25.
- Early Prediction Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nehal A Parikh, DO, MS principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant, run by Children's Hospital Medical Center, Cincinnati at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Motor development (time frame: 2 years of age, corrected for prematurity). The study lists 3 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 NCT03345069, which also lists 15 linked publications.
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 7 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.