Cerebral Palsy InfantileNCT03530189
Outcome of Very Preterm Infants With Glucose Level Disturbances
An observational study of Cerebral Palsy Infantile, run by University Hospital Rijeka at 1 site in Croatia.
Trial summary
The hypothesis of this prospective, cohort study is that hyperglycemia, hypoglycemia and unstable glucose levels in the first seven days of life in infants born very preterm and at very low birth weights can harm long-term neurodevelopment. Read more about this study
- Who is it for?
- Ages 24 weeks to 27 months
- Conditions the study is for
- Cerebral Palsy Infantile
- What is being tested?
- 10% dextrose and bolus of dextrose, reducing the glucose infusion, insulin
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 24 weeks to 27 months
- All sexes
- No healthy volunteers
- Child
Study population: We will include all infants born before 32 of weeks gestation or weighing below 1500 g and admitted to the Neonatal intensive care unit (NICU) of University Hospital Center Rijeka. Blood glucose concentrations will be measured and recorded from birth until the end of postnatal day 7. Based on the values of glucose concentrations, infantsi will be categorized as normoglycemic, hypoglycemic, hyperglycemic and unstable. At the age between 22,5 and 26,5 months of corrected age assessment by neurologist and psychologist will be performed. This study is approved by Ethics Committee of University Hospital Center Rijeka and by the Ethics Committee of University of Rijeka - Faculty of Medicine.
Who may be able to join
- infants born weighing <1500 g or at <32 weeks of gestation
Who cannot join
- infants with significant congenital abnormalities
- infants died before day 7
- infants whose mothers suffer from type 1, type 2 diabetes mellitus or gestational diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurodevelopmental Outcome of Very Preterm Infants With Glucose Level Disturbances at the Age of Two
The hypothesis of this prospective, cohort study is that hyperglycemia, hypoglycemia and unstable glucose levels in the first seven days of life in infants born very preterm and at very low birth weights can harm long-term neurodevelopment. The objective of the study is to investigate the relationship between early neonatal glycemia, neonatal characteristics, and developmental outcomes in preterm infants. All infants born before 32. gestational week or below 1500 g admitted to the neonatal intensive care unit will be included in the study. According to the glucose values, the infants will be divided into the normoglycemic group and the group with disturbed glucose concentration. In the corrected age of two neurodevelopmental outcome will be assessed and categorized as normal, mild, moderate or severe impairment. Since the results of published studies about the effects of asymptomatic neonatal hypoglycemia and hyperglycemia on neurodevelopment are inconsistent, the correlation between early disturbances in glucose levels and neurodevelopmental outcome will be assessed.
Read the detailed description
All infants born before 32 weeks of gestation or weighing <1500 g and admitted to the Neonatal intensive care unit of the University Hospital Center Rijeka will be included into the study. The investigators will collect data from the neonatal period, including: gestational age, sex, birth weight, Apgar score at 1 and 5 minutes, socioeconomic status and Clinical Risk Index for Babies scoring system (CRIB II). Blood glucose levels will be measured at 3rd, 12th, and 18th hour after birth on the first day of life, and from the 2nd to the 7th day of life blood glucose levels will be measured once a day. According to the blood glucose concentrations infants will be divided into normoglycemic group and group with disturbed glucose concentration. The relationship between glycemia category and 2-year outcomes will be investigated. In the corrected age of two years neurodevelopmental outcome will be assessed. Certified psychologists will assess cognitive, motor and language development with the Bayley Scales of Infant and Toddler Development (Bayley III). Bayley III scales are standardized to a mean (SD) score of 100. Pediatric neurologists or pediatrics will examine the children and will estimate the neuromotor function. Cognitive, motor and language development were considered normal if the composite score on the respective Bayley-III score was ≥mean -1SD; mildly impaired if the score was < -1 SD and ≥ -2 SD; moderately impaired if the score was <-2 SD and ≥3 SD; and severely impaired if the score was < mean -3SD.
Cerebral palsy (CP) was evaluated according to the European Cerebral Palsy Network definition. The severity of CP was classified as mild in children who were able to walk without an aid, moderate in children able to walk with an aid, and severe in children who were unable to walk even with an aid.
Children unable to fixate and follow a light with either eye were considered bilaterally blind. Children registered at low-vision centers without blindness were recorded as having moderate visual impairment. Severe auditory impairment was defined as hearing loss that could not be corrected with a hearing aid and moderate auditory impairment was defined as hearing loss corrected with a hearing aid.
The overall outcome was categorized as normal, mild, moderate or severe impairment. Mild impairment was defined as scores between -1and -2 standard deviations from the mean of any of the Bayley-III scales or mild CP. Moderate impairment was defined as scores between -2and -3 standard deviations from the mean of any of the Bayley-III scales, moderate CP, or moderate visual or hearing impairment. Severe impairment was defined as scores between < mean -3 standard deviations of any of the Bayley-III scales, severe CP, or bilateral blindness or deafness.
- Conditions
- Cerebral Palsy Infantile
- Being tested
- 10% dextrose, bolus of dextrose, reducing the glucose infusion, insulin
- Keywords
- Hyperglycemia;, Hypoglycemia;, Neurodevelopment;, Prematurity
- Medical subject headings
- Cerebral Palsy, Hyperglycemia, Hypoglycemia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% dextroseDrug
Also called There is no other intervention names
After birth the intravenous 10% dextrose at 60-90 ml/kg/day will be started as soon as possible
bolus of dextrose, reducing the glucose infusion, insulinDrug
Also called There is no other intervention names
Hypoglycemia will be treated with 2 mL/kg to 3 mL/kg (200-300 mg/kg) intravenous bolus of 10% dextrose.
Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion.
| Study group | Role | What they receive |
|---|---|---|
| Normoglycemic group | The infant will enter this group if a single blood glucose concentration is between 2.1 and 2.5 mmol/l (38-45 mg/dL), or a single blood glucose concentration is between 8.6 - 10 mmol/l (155-180 mg/dL) with all other measures between 2.6 and 8.5 mmol/l (47-153 mg/dL).
To all premature infants intravenous 10% dextrose at 60-90 mL/kg/day will be started as soon as possible after birth. Receives: Drug: 10% dextrose | |
| Group with impaired glucose | The infant can be hypoglycemic, hyperglycemic or unstable. The infant will be hypoglycemic if blood glucose concentration is ≤2,5 mmol/l (45 mg/dL) on ≥2 measures >1 hour apart, or any blood glucose concentration is≤2,0 mmol/l (36 mg/dL). Hypoglycemia will be treated with intravenous bolus of 10% dextrose.
The infant will be hyperglycemic if blood glucose concentration is ≥8,6 mmol/l (155 mg/dL) on ≥2 measures >1 hour apart, or any blood glucose concentration ≥10,1 mmol/l (182 mg/dL). Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion.
The infant will be unstable if at least 1 blood glucose concentration is ≤2,5 mmol/l (45 mg/dL) and ≥1 blood glucose concentration is ≥8,6 mmol/l (155 mg/dL). Receives: Drug: bolus of dextrose, reducing the glucose infusion, insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental outcome of each group at the age of two performed using Bayley Scales of Infant and Toddler Development Bayley III
Mild impairment was defined as scores between -1and -2 standard deviations (70 - 85) from the mean of any of the Bayley-III scales or mild CP. Moderate impairment was defined as scores between -2and -3 standard deviations (55 - 70) from the mean of any of the Bayley-III scales, moderate CP, or moderate visual or hearing impairment. Severe impairment was defined as scores between < mean -3 standard deviations (<55) of any of the Bayley-III scales, severe CP, or bilateral blindness or deafness.
Measured: up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy InfantileStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivona Butorac Ahel, University Hospital Rijeka
- Investigators
- Ivona Butorac Ahel, MD, MS, Principal investigator, University Hospital Center Rijeka, 51 000 Rijeka, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530189
- Sponsor's protocol ID
- istrazivanje01
- Status last verified
- Aug 2023
- First submitted
- 22 Apr 2018
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tottman AC, Alsweiler JM, Bloomfield FH, Gamble G, Jiang Y, Leung M, Poppe T, Thompson B, Wouldes TA, Harding JE; PIANO Study Group. Long-Term Outcomes of Hyperglycemic Preterm Infants Randomized to Tight Glycemic Control. J Pediatr. 2018 Feb;193:68-75.e1. doi: 10.1016/j.jpeds.2017.09.081. Epub 2017 Dec 1.
PubMed 29198539Sinclair JC, Bottino M, Cowett RM. Interventions for prevention of neonatal hyperglycemia in very low birth weight infants. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD007615. doi: 10.1002/14651858.CD007615.pub3.
PubMed 21975772Mitanchez D. Glucose regulation in preterm newborn infants. Horm Res. 2007;68(6):265-71. doi: 10.1159/000104174. Epub 2007 Jun 20.
PubMed 17587854Goode RH, Rettiganti M, Li J, Lyle RE, Whiteside-Mansell L, Barrett KW, Casey PH. Developmental Outcomes of Preterm Infants With Neonatal Hypoglycemia. Pediatrics. 2016 Dec;138(6):e20161424. doi: 10.1542/peds.2016-1424. Epub 2016 Nov 4.
PubMed 27940690Tin W, Brunskill G, Kelly T, Fritz S. 15-year follow-up of recurrent "hypoglycemia" in preterm infants. Pediatrics. 2012 Dec;130(6):e1497-503. doi: 10.1542/peds.2012-0776. Epub 2012 Nov 5.
PubMed 23129080Lucas A, Morley R, Cole TJ. Adverse neurodevelopmental outcome of moderate neonatal hypoglycaemia. BMJ. 1988 Nov 19;297(6659):1304-8. doi: 10.1136/bmj.297.6659.1304.
PubMed 2462455Hey E. Hyperglycaemia and the very preterm baby. Semin Fetal Neonatal Med. 2005 Aug;10(4):377-87. doi: 10.1016/j.siny.2005.04.008.
PubMed 15927546Decaro MH, Vain NE. Hyperglycaemia in preterm neonates: what to know, what to do. Early Hum Dev. 2011 Mar;87 Suppl 1:S19-22. doi: 10.1016/j.earlhumdev.2011.01.005. Epub 2011 Jan 26.
PubMed 21276670Surveillance of Cerebral Palsy in Europe. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE). Dev Med Child Neurol. 2000 Dec;42(12):816-24. doi: 10.1017/s0012162200001511.
PubMed 11132255
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcome of Very Preterm Infants With Glucose Level Disturbances at the Age of Two
- ClinicalTrials.gov ID
- NCT03530189
- Acronym / sponsor ID
- istrazivanje01
- Conditions
- Cerebral Palsy Infantile
- Keywords
- Hyperglycemia;, Hypoglycemia;, Neurodevelopment;, Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 May 2018 (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 hypothesis of this prospective, cohort study is that hyperglycemia, hypoglycemia and unstable glucose levels in the first seven days of life in infants born very preterm and at very low birth weights can harm long-term neurodevelopment. The objective of the study is to investigate the relationship between early neonatal glycemia, neonatal characteristics, and developmental outcomes in preterm infants. All infants born before 32. gestational week or below 1500 g admitted to the neonatal intensive care unit will be included in the study. According to the glucose values, the infants will be divided into the normoglycemic group and the group with disturbed glucose concentration. In the corrected age of two neurodevelopmental outcome will be assessed and categorized as normal, mild, moderate or severe impairment. Since the results of published studies about the effects of asymptomatic neonatal hypoglycemia and hyperglycemia on neurodevelopment are inconsistent, the correlation between early disturbances in glucose levels and neurodevelopmental outcome will be assessed.
Detailed description
All infants born before 32 weeks of gestation or weighing <1500 g and admitted to the Neonatal intensive care unit of the University Hospital Center Rijeka will be included into the study. The investigators will collect data from the neonatal period, including: gestational age, sex, birth weight, Apgar score at 1 and 5 minutes, socioeconomic status and Clinical Risk Index for Babies scoring system (CRIB II). Blood glucose levels will be measured at 3rd, 12th, and 18th hour after birth on the first day of life, and from the 2nd to the 7th day of life blood glucose levels will be measured once a day. According to the blood glucose concentrations infants will be divided into normoglycemic group and group with disturbed glucose concentration. The relationship between glycemia category and 2-year outcomes will be investigated. In the corrected age of two years neurodevelopmental outcome will be assessed. Certified psychologists will assess cognitive, motor and language development with the Bayley Scales of Infant and Toddler Development (Bayley III). Bayley III scales are standardized to a mean (SD) score of 100. Pediatric neurologists or pediatrics will examine the children and will estimate the neuromotor function. Cognitive, motor and language development were considered normal if the composite score on the respective Bayley-III score was ≥mean -1SD; mildly impaired if the score was < -1 SD and ≥ -2 SD; moderately impaired if the score was <-2 SD and ≥3 SD; and severely impaired if the score was < mean -3SD.
Cerebral palsy (CP) was evaluated according to the European Cerebral Palsy Network definition. The severity of CP was classified as mild in children who were able to walk without an aid, moderate in children able to walk with an aid, and severe in children who were unable to walk even with an aid.
Children unable to fixate and follow a light with either eye were considered bilaterally blind. Children registered at low-vision centers without blindness were recorded as having moderate visual impairment. Severe auditory impairment was defined as hearing loss that could not be corrected with a hearing aid and moderate auditory impairment was defined as hearing loss corrected with a hearing aid.
The overall outcome was categorized as normal, mild, moderate or severe impairment. Mild impairment was defined as scores between -1and -2 standard deviations from the mean of any of the Bayley-III scales or mild CP. Moderate impairment was defined as scores between -2and -3 standard deviations from the mean of any of the Bayley-III scales, moderate CP, or moderate visual or hearing impairment. Severe impairment was defined as scores between < mean -3 standard deviations of any of the Bayley-III scales, severe CP, or bilateral blindness or deafness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoglycemic group | – | Drug: 10% dextroseThe infant will enter this group if a single blood glucose concentration is between 2.1 and 2.5 mmol/l (38-45 mg/dL), or a single blood glucose concentration is between 8.6 - 10 mmol/l (155-180 mg/dL) with all other measures between 2.6 and 8.5 mmol/l (47-153 mg/dL). To all premature infants intravenous 10% dextrose at 60-90 mL/kg/day will be started as soon as possible after birth. |
| Group with impaired glucose | – | Drug: bolus of dextrose, reducing the glucose infusion, insulinThe infant can be hypoglycemic, hyperglycemic or unstable. The infant will be hypoglycemic if blood glucose concentration is ≤2,5 mmol/l (45 mg/dL) on ≥2 measures >1 hour apart, or any blood glucose concentration is≤2,0 mmol/l (36 mg/dL). Hypoglycemia will be treated with intravenous bolus of 10% dextrose. The infant will be hyperglycemic if blood glucose concentration is ≥8,6 mmol/l (155 mg/dL) on ≥2 measures >1 hour apart, or any blood glucose concentration ≥10,1 mmol/l (182 mg/dL). Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion. The infant will be unstable if at least 1 blood glucose concentration is ≤2,5 mmol/l (45 mg/dL) and ≥1 blood glucose concentration is ≥8,6 mmol/l (155 mg/dL). |
Who may qualify
- Ages
- 24 weeks to 27 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We will include all infants born before 32 of weeks gestation or weighing below 1500 g and admitted to the Neonatal intensive care unit (NICU) of University Hospital Center Rijeka. Blood glucose concentrations will be measured and recorded from birth until the end of postnatal day 7. Based on the values of glucose concentrations, infantsi will be categorized as normoglycemic, hypoglycemic, hyperglycemic and unstable. At the age between 22,5 and 26,5 months of corrected age assessment by neurologist and psychologist will be performed. This study is approved by Ethics Committee of University Hospital Center Rijeka and by the Ethics Committee of University of Rijeka - Faculty of Medicine.
Key inclusion criteria (1 listed)
- infants born weighing <1500 g or at <32 weeks of gestation
Key exclusion criteria (3 listed)
- infants with significant congenital abnormalities
- infants died before day 7
- infants whose mothers suffer from type 1, type 2 diabetes mellitus or gestational diabetes
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 |
|---|---|---|
| 10% dextroseAlso: There is no other intervention namesAfter birth the intravenous 10% dextrose at 60-90 ml/kg/day will be started as soon as possible | Drug | Normoglycemic group |
| bolus of dextrose, reducing the glucose infusion, insulinAlso: There is no other intervention namesHypoglycemia will be treated with 2 mL/kg to 3 mL/kg (200-300 mg/kg) intravenous bolus of 10% dextrose. Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion. | Drug | Group with impaired glucose |
Primary outcome
Neurodevelopmental outcome of each group at the age of two performed using Bayley Scales of Infant and Toddler Development Bayley III
Time frame: up to 27 months
Mild impairment was defined as scores between -1and -2 standard deviations (70 - 85) from the mean of any of the Bayley-III scales or mild CP. Moderate impairment was defined as scores between -2and -3 standard deviations (55 - 70) from the mean of any of the Bayley-III scales, moderate CP, or moderate visual or hearing impairment. Severe impairment was defined as scores between < mean -3 standard deviations (<55) of any of the Bayley-III scales, severe CP, or bilateral blindness or deafness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 29198539Tottman AC, Alsweiler JM, Bloomfield FH, Gamble G, Jiang Y, Leung M, Poppe T, Thompson B, Wouldes TA, Harding JE; PIANO Study Group. Long-Term Outcomes of Hyperglycemic Preterm Infants Randomized to Tight Glycemic Control. J Pediatr. 2018 Feb;193:68-75.e1. doi: 10.1016/j.jpeds.2017.09.081. Epub 2017 Dec 1.
- Background: PubMed 21975772Sinclair JC, Bottino M, Cowett RM. Interventions for prevention of neonatal hyperglycemia in very low birth weight infants. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD007615. doi: 10.1002/14651858.CD007615.pub3.
- Background: PubMed 17587854Mitanchez D. Glucose regulation in preterm newborn infants. Horm Res. 2007;68(6):265-71. doi: 10.1159/000104174. Epub 2007 Jun 20.
- Background: PubMed 27940690Goode RH, Rettiganti M, Li J, Lyle RE, Whiteside-Mansell L, Barrett KW, Casey PH. Developmental Outcomes of Preterm Infants With Neonatal Hypoglycemia. Pediatrics. 2016 Dec;138(6):e20161424. doi: 10.1542/peds.2016-1424. Epub 2016 Nov 4.
- Background: PubMed 23129080Tin W, Brunskill G, Kelly T, Fritz S. 15-year follow-up of recurrent "hypoglycemia" in preterm infants. Pediatrics. 2012 Dec;130(6):e1497-503. doi: 10.1542/peds.2012-0776. Epub 2012 Nov 5.
- Background: PubMed 2462455Lucas A, Morley R, Cole TJ. Adverse neurodevelopmental outcome of moderate neonatal hypoglycaemia. BMJ. 1988 Nov 19;297(6659):1304-8. doi: 10.1136/bmj.297.6659.1304.
- Background: PubMed 15927546Hey E. Hyperglycaemia and the very preterm baby. Semin Fetal Neonatal Med. 2005 Aug;10(4):377-87. doi: 10.1016/j.siny.2005.04.008.
- Background: PubMed 21276670Decaro MH, Vain NE. Hyperglycaemia in preterm neonates: what to know, what to do. Early Hum Dev. 2011 Mar;87 Suppl 1:S19-22. doi: 10.1016/j.earlhumdev.2011.01.005. Epub 2011 Jan 26.
- Background: PubMed 11132255Surveillance of Cerebral Palsy in Europe. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE). Dev Med Child Neurol. 2000 Dec;42(12):816-24. doi: 10.1017/s0012162200001511.
- Individual participant dataSharing planned: Undecided
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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.
Ivona Butorac Ahel, MD, MS principal investigator
University Hospital Center Rijeka, 51 000 Rijeka, Croatia
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 Cerebral Palsy Infantile, run by University Hospital Rijeka at 1 site in Croatia.
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 3 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 29 Aug 2023. 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 Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurodevelopmental outcome of each group at the age of two performed using Bayley Scales of Infant and Toddler Development Bayley III (time frame: up to 27 months). 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 NCT03530189, which also lists 9 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 29 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.