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Clinical Trials/NL-OMON30243
NL-OMON30243
Not yet recruiting
Not Applicable

Brain development after prenatal growth retardation; effects of growth hormone treatment - brain development after prenatal growth retardation; growth hormone

Vrije Universiteit Medisch Centrum0 sites110 target enrollmentTBD
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Conditionssmall for gestational age / intra uterine growth failure1002111210010273

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
small for gestational age / intra uterine growth failure
Sponsor
Vrije Universiteit Medisch Centrum
Enrollment
110
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Indications for GH treatment is based on the protocol as described by the dutch Working group on Growth Hormone
  • •inclusioncriteria for group A (SGA\-short; without GH treatment):
  • •\- Birth weight or birth length below \*2 SD adjusted for duration of pregnancy.
  • •\- Present height below \*2\.5 SD and below minus 1 SD target height\-SDS.
  • •\- Calendar age between 4 and 6 years.
  • •\- No evidence of catch up growth during the preceding year.
  • •\- Children are under regular control by pediatrician, but do not choose to be treated with GH ;Inclusion criteria group B: (SGA\-short; with GH treatment)
  • •This is a patient population who meet the criteria for SGA\-short, (see inclusion criteria group a) and are willing to be treated with GH. ;Inclusion criteria group C (SGA\-normal height):
  • •\- Birth weight or birth length below \*2 SD adjusted for duration of pregnancy.
  • •\- Present height above \-2\.0 SD and above minus 1 SD of target height \-SDS.

Exclusion Criteria

  • •Dysmorphic criteria or a known syndrome (except for Silver Russell syndrome)
  • •Skeletal dysplasia
  • •Serious complications in the neonatal period
  • •Other diseases, responsible for growth failure
  • •Medication influencing growth
  • •Psychomotor retardation
  • •Prematurity \< 35 weeks

Outcomes

Primary Outcomes

Not specified

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