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Indicators of Growth, Nutritional Status and Comorbide Disorders of Newborns With Down Syndrome (DownSy)

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ClinicalTrials.gov Identifier: NCT03553706
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Asija Rota Ceprnja, University Hospital of Split

Brief 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 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.


Condition or disease
Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction

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).


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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interference Indicators of Growth, Nutritional Status and Comorbid Malformations of Newborns With Down Syndrome (DS)
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • excluded newborns with proven trisomy 21 died at first week of life

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553706


Locations
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Croatia
Asija Rota Ceprnja
Split, Dalmatia, Croatia, +385 21
Sponsors and Collaborators
University Hospital of Split
Investigators
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Principal Investigator: Asija Rota Ceprnja, MD University Hospital Split Department for Rehabilitation

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Responsible Party: Asija Rota Ceprnja, Asija Rota Ceprnja, MD., specialist of rehabilitation, University Hospital of Split
ClinicalTrials.gov Identifier: NCT03553706     History of Changes
Other Study ID Numbers: KBC2052018
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asija Rota Ceprnja, University Hospital of Split:
growth restriction, nutritive status, comorbide disorders, Down Syndrome

Additional relevant MeSH terms:
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Syndrome
Down Syndrome
Fetal Growth Retardation
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Fetal Diseases
Pregnancy Complications
Growth Disorders