Brain Development after prenatal growth retardation: effects of growth hormone treatment

Not Applicable

Completed

• Conditions: Small for Gestational Age (SGA), brain development; Nutritional, Metabolic, Endocrine; Brain development

• Registration Number: ISRCTN20279720
• Lead Sponsor: Pfizer B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Study Completion: 2011-03-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Inclusion criteria group A/B:
1. Birth weight or birth length below -2 Standard Deviation (SD) adjusted for duration of pregnancy
2. Present height below -2.5 SD and at least 1 SD below target height-SD score
3. Calendar age between four and six 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 Growth Hormone (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 -SD score

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 (Target Height [TH] ± 1 SD)

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 less than three 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 Growth Hormone Deficiency (GHD)
5. Medications or interventions during the previous six 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, Luteinising Hormone-Releasing Hormone (LHRH) analogue
7. Active or treated malignancy or increased risk of leukaemia
8. Serious suspicion of psychosocial dwarfism (emotional deprivation)
9. Severe neurological disability
10. Expected non-compliance
11. Prematurity less than 35 weeks
12. For Magnetoencephalography (MEG)/Magnetic Resonance Imaging (MRI) investigation: treatment with irremovable metal wires

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. To determine the effect of prenatal growth retardation on brain functioning/development<br> 2. To determine the effect of growth hormone treatment on brain functioning/development in children born after prenatal growth retardation<br> 3. To assess wether there is a difference in brain development in between SGA children with and without postnatal catch up growth<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures