NCT03553706: DownSy

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

Completed Last updated 12 June 2018

What this trial tests

trial in Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction in 141 participants. Completed in 30 May 2018.

Timeline

20 May 2018

Primary endpoint
30 May 2018

30 May 2018

Quick facts

Lead sponsor	University Hospital of Split
Status	Completed
Study type	OBSERVATIONAL
Enrollment	141
Start date	20 May 2018
Primary completion	30 May 2018
Estimated completion	30 May 2018
Sites	1 location across Croatia

Conditions studied

• Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction — all drugs for Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction →

Sponsor

University Hospital of Split

Who can join

Adults 1 Day to 1 Month, any sex, with Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of Neonatal Body (Dis)Proportionality Determined by the Cephalization Index (CI) on Gross Motor Development in Children with Down Syndrome: A Prospective Cohort Study.
   Rota Čeprnja A, Pranić SM, Šunj M, Kozina T, et al · · 2022 · PMID 36670564 · DOI 10.3390/children10010013