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

Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction Clinical Trial

— DownSy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553706
• Other study ID #: KBC2052018
• Status: Completed
• Start date: May 20, 2018
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2018
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction
• Fetal Growth Retardation
• Syndrome

Locations

Country	Name	City	State
Croatia	Asija Rota Ceprnja	Split	Dalmatia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days
Primary	Testing the differences of auxological characteristic according to gestational age	Comparison of auxological parameters and auxological indexes of premature and term babies with DS	7 days
Primary	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	7 days