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Brain development after prenatal growth retardation; effects of growth hormone treatment.

Brain development after prenatal growth retardation; effects of growth hormone treatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29167
Enrollment
110
Registered
2007-01-05
Start date
2007-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Study populations: group A/B: small for gestational age (sga), children without complete catch up growth with and without growth hormone treatment group C: sga with complete catch up growth group D:. Children born with a normal birth weight/length and a normal postnatal growth.

Interventions

Structural (only at baseline) and functional MRI’s, MEG and extensive neuropsychologic testing will be performed at baseline, after one year and three years in both groups A (treatment with growth hor

Sponsors

Prof Dr HA Delemarre- van de Waal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria group A/B: 1.Birth weight or birth length below –2 SD adjusted for duration of pregnancy; 2. Present height below –2.5 SD and at least 1 SD below target height-SDS; 3. Calendar age between 4 and 6 years. 4. No evidence of catch up growth during the preceding year; 5. Children are under regular control by pediatrician, choose to be or not to be treated with GH. Inclusion criteria group C: 1. Birth weight or birth length below –2 SD adjusted for duration of pregnancy; 2. Present height above -2.0 SD and above minus 1 SD of target height -SDS. Inclusion criteria group D: 1. Normal birth weight/length adjusted for duration of pregnancy; 2. Present height above –2 SD for age and within target range (TH ± 1SD ).

Exclusion criteria

Exclusion criteria: 1. Known syndromes and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described, except for Silver Russell Syndrome; 2. Severe asphyxia (defined as Apgar score <3 after 5 minutes), and no serious diseases such as long-term artificial ventilation and oxygen supply, bronchopulmonary dysplasia or other chronic lung disease; 3. Coeliac disease and other chronic or serious diseases of the gastrointestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies; 4. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except of GHD; 5. Medications or interventions during the previous 6 months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroid inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine or extremities); 6. Use of medication that might interfere with growth during GH therapy, such as corticosteroids, sex steroids, LHRH analogue; 7. Active or treated malignancy or increased risk of leukemia; 8. Serious suspicion of psychosocial dwarfism (emotional deprivation); 9. Severe neurological disability; 10. Expected non-compliance; 11. Prematurity < 35 weeks; 12. For MEG/MRI investigation: Treatment with irremovable metal wires.

Design outcomes

Primary

MeasureTime frame
1. To determine the effect of prenatal growth retardation on brain functioning / development; 2. to determine the effect of growth hormone treatment on brain functioning / development in children born after prenatal growth retardation; 3. to assess wether there is a difference in brain development in between sga children with and without postnatal catch up growth.

Contacts

Public ContactH.M.A. Bie, de

VU Medisch Centrum, Kinderendocrinologie

b.debie@vumc.nl+ 31 20-4440895

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)