Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth RestrictionDownSyNCT03553706
Indicators of Growth, Nutritional Status and Comorbide Disorders of Newborns With Down Syndrome
An observational study of Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction, run by University Hospital of Split at 1 site in Croatia.
Trial summary
Objective To access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS) Study design In this cohort retrospective study, 141 newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split… Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction
- How many people
- 141 participants
- Where
- 1 siteCroatia
- Study dates
- 20 May 2018to 30 May 2018
- 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: The perinatal outcome of 141 children with confirmed diagnosis of DS was evaluated retrospectively. 137 (137/141, 97.2%) children had the cytogenetic finding of regular trisomy 21, 3 (3/141, 2.1%) had the kariotypic finding of mosaicism and 1 child (1/ 141. %) had translocation 21/22. There were more boys (74/141, 52.5%) than girls (67/141, 47.5%) in the examined sample. The median of gestational age of newborns with DS was 38 weeks (range 37-38 weeks): 10 children were born at 40 weeks of gestation (7.1%), 34 at 38 weeks (24.1%), 24 at 37 weeks (16.3%), 15 children (10.6%) at 36 weeks; and 19 children from 32 to 35 weeks of gestation. The median of gravidity for boys was the 3rd pregnancy, and for girls the 2nd pregnancy. The age range of the mother for both sexes was 31 to 35 years.
Who may be able to join
- The study included newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital Center from 1990 to 2015
Who cannot join
- excluded newborns with proven trisomy 21 died at first week of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interference Indicators of Growth, Nutritional Status and Comorbid Malformations of Newborns With Down Syndrome (DS)
Objective To access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)
Study design In this cohort retrospective study, 141 newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital (1990 to 2015) were included. The data were obtained from the medical histories of mothers, infants and the delivery protocol.
Read more
The objective was to access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)
Conclusion Higher CI were found in hyportrophic (SGA) newborns with DS and indicated their intrauterine growth restriction with brain sparing and increased further risk of severe psychomotor retardation. The SGA newborns have lower parameters and indexes of nutritive status and significantly differed from eutrophic and hypertrophic newborns. These SGA newborns with DS have increased developmental risks and that requires further diagnostic attention.
Read the detailed description
Use of anthropometric charts developed specifically for children with DS have a better expression of real growth restriction (small for gestation age/SGA, 9.9%) than the application of the percentile curve for typical children (SGA, 24.1%). These differences were also noted in the evaluation of other anthropometric measures. Cephalization index (CI) proved to be the only predictor from the considered auxological parameters and indexes with minimal predictive value in the prediction of heart defects type ASD II and VSD.
The presence of comorbid disorders in newborns with DS did not have a significant predictive role on growth indicators and nutritive status of the newborn, but we noted a strong association between preterm births and white matter injury (WMI).
- Conditions
- Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction
- Keywords
- growth restriction, nutritive status, comorbide disorders, Down Syndrome
- Medical subject headings
- Down Syndrome, Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorization of subjects according to norms of growth rates for typical children and children with Down syndrome
Comparison of children with Down syndrome according to values of birth weight, birth length and head circumference classified by anthropometric charts for typical children and anthropometric charts for children with DS
Measured: 7 days
Testing the differences of auxological characteristic according to gestational age
Comparison of auxological parameters and auxological indexes of premature and term babies with DS
Measured: 7 days
Auxological characteristics of SGA, AGA and LGA children with DS by norms for DS
Comparison of auxological parameters and auxological indexes between hypotrophic (SGA), eutrophic (AGA) and hypertrophic (HGA) children with DS
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start20 May 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth RestrictionStudies 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
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asija Rota Ceprnja, University Hospital of Split
- Investigators
- Asija Rota Ceprnja, MD, Principal investigator, University Hospital Split Department for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553706
- Sponsor's protocol ID
- KBC2052018
- Acronym
- DownSy
- Status last verified
- May 2018
- First submitted
- 30 May 2018
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interference Indicators of Growth, Nutritional Status and Comorbid Malformations of Newborns With Down Syndrome (DS)
- ClinicalTrials.gov ID
- NCT03553706
- Acronym / sponsor ID
- DownSy / KBC2052018
- Conditions
- Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction
- Keywords
- growth restriction, nutritive status, comorbide disorders, Down Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 12 Jun 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.
Objective To access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)
Study design In this cohort retrospective study, 141 newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital (1990 to 2015) were included. The data were obtained from the medical histories of mothers, infants and the delivery protocol.
The objective was to access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)
Conclusion Higher CI were found in hyportrophic (SGA) newborns with DS and indicated their intrauterine growth restriction with brain sparing and increased further risk of severe psychomotor retardation. The SGA newborns have lower parameters and indexes of nutritive status and significantly differed from eutrophic and hypertrophic newborns. These SGA newborns with DS have increased developmental risks and that requires further diagnostic attention.
Detailed description
Use of anthropometric charts developed specifically for children with DS have a better expression of real growth restriction (small for gestation age/SGA, 9.9%) than the application of the percentile curve for typical children (SGA, 24.1%). These differences were also noted in the evaluation of other anthropometric measures. Cephalization index (CI) proved to be the only predictor from the considered auxological parameters and indexes with minimal predictive value in the prediction of heart defects type ASD II and VSD.
The presence of comorbid disorders in newborns with DS did not have a significant predictive role on growth indicators and nutritive status of the newborn, but we noted a strong association between preterm births and white matter injury (WMI).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The perinatal outcome of 141 children with confirmed diagnosis of DS was evaluated retrospectively. 137 (137/141, 97.2%) children had the cytogenetic finding of regular trisomy 21, 3 (3/141, 2.1%) had the kariotypic finding of mosaicism and 1 child (1/ 141. %) had translocation 21/22. There were more boys (74/141, 52.5%) than girls (67/141, 47.5%) in the examined sample. The median of gestational age of newborns with DS was 38 weeks (range 37-38 weeks): 10 children were born at 40 weeks of gestation (7.1%), 34 at 38 weeks (24.1%), 24 at 37 weeks (16.3%), 15 children (10.6%) at 36 weeks; and 19 children from 32 to 35 weeks of gestation. The median of gravidity for boys was the 3rd pregnancy, and for girls the 2nd pregnancy. The age range of the mother for both sexes was 31 to 35 years.
Key inclusion criteria (1 listed)
- The study included newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital Center from 1990 to 2015
Key exclusion criteria (1 listed)
- excluded newborns with proven trisomy 21 died at first week of life
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
Categorization of subjects according to norms of growth rates for typical children and children with Down syndrome
Time frame: 7 days
Comparison of children with Down syndrome according to values of birth weight, birth length and head circumference classified by anthropometric charts for typical children and anthropometric charts for children with DS
Testing the differences of auxological characteristic according to gestational age
Time frame: 7 days
Comparison of auxological parameters and auxological indexes of premature and term babies with DS
Auxological characteristics of SGA, AGA and LGA children with DS by norms for DS
Time frame: 7 days
Comparison of auxological parameters and auxological indexes between hypotrophic (SGA), eutrophic (AGA) and hypertrophic (HGA) children with DS
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 12 Jun 2018.
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.
Asija Rota Ceprnja, MD principal investigator
University Hospital Split Department for Rehabilitation
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 Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction, run by University Hospital of Split 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 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 12 Jun 2018. 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?
Categorization of subjects according to norms of growth rates for typical children and children with Down syndrome (time frame: 7 days). 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?
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 12 Jun 2018.