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Completed

NCT Number: NCT03553706

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital of Split

Other

Registry information

Official study title

Interference Indicators of Growth, Nutritional Status and Comorbid Malformations of Newborns With Down Syndrome (DS)

Acronym: DownSy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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