A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin(®) ) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study

De Schepper, Jean; Vanderfaeillie, Johan; Mullis, Primus-Eugen; Rooman, Raoul; Robertson, Anna; Dilleen, Maria; Gomez, Roy; Wollmann, Hartmut A (2016). A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin(®) ) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study. Clinical endocrinology, 84(3), pp. 353-360. Blackwell Scientific Publications 10.1111/cen.12968

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OBJECTIVE

In Europe, growth hormone (GH) treatment for children born small for gestational age (SGA) can only be initiated after 4 years of age. However, younger age at treatment initiation is a predictor of favourable response. To assess the effect of GH treatment on early growth and cognitive functioning in very young (<30 months), short-stature children born SGA.

DESIGN

A 2-year, randomized controlled, multicentre study (NCT00627523; EGN study), in which patients received either GH treatment or no treatment for 24 months.

PATIENTS

Children aged 19-29 months diagnosed as SGA at birth, and for whom sufficient early growth data were available, were eligible. Patients were randomized (1:1) to GH treatment (Genotropin(®) , Pfizer Inc.) at a dose of 0·035 mg/kg/day by subcutaneous injection, or no treatment.

MEASUREMENTS

The primary objective was to assess the change from baseline in height standard deviation score (SDS) after 24 months of GH treatment.

RESULTS

Change from baseline in height SDS was significantly greater in the GH treatment vs control group at both month 12 (1·03 vs 0·14) and month 24 (1·63 vs 0·43; both P < 0·001). Growth velocity SDS was significantly higher in the GH treatment vs control group at 12 months (P < 0·001), but not at 24 months. There was no significant difference in mental or psychomotor development indices between the two groups.

CONCLUSIONS

GH treatment for 24 months in very young short-stature children born SGA resulted in a significant increase in height SDS compared with no treatment.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Endokrinologie / Diabetologie / Metabolik (Pädiatrie)
04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Paediatric Medicine

UniBE Contributor:

Mullis, Primus-Eugen

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0300-0664

Publisher:

Blackwell Scientific Publications

Language:

English

Submitter:

Anette van Dorland

Date Deposited:

02 May 2016 11:28

Last Modified:

05 Dec 2022 14:53

Publisher DOI:

10.1111/cen.12968

PubMed ID:

26501737

BORIS DOI:

10.7892/boris.79366

URI:

https://boris.unibe.ch/id/eprint/79366

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