Actively Recruiting
A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants
Led by Tongji Hospital · Updated on 2023-04-19
138
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
C
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cognitive impairment is independently related to low birth weight, low birth length and small head circumference. SGA children who have not experienced height and / or head circumference catch-up have the worst cognitive function. The serum IGF-1 level of short SGA children is significantly lower than that of catch-up SGA children. This may be due to the defect of GH-IGF-1 axis, resulting in some hGH / IGF-1 deficiency. GH treatment can induce catch-up growth of head circumference, especially for those with small birth head circumference, growth hormone can help to improve IQ, behavior and self cognition of children with SGA. Two years after birth is the most critical period for children's physical, neurological, cognitive and emotional development. This study evaluated the effect of growth hormone treatment on the improvement of cognitive function and growth and development of symmetrical SGA children who did not show catch-up growth from 6 months to 2 years old. This is an innovative study. The minimum age of previous similar studies is 19 months. The starting age of this study is 6 months, and the results are to improve the cognitive development of SGA infants. This is the first of its kind. Although the safety of growth hormone in SGA infants younger than 2 years old has not been reported, it is based on a number of studies on the application of growth hormone in infants, such as PWS and GHD, It can be expected that there will be no short-term and long-term adverse reactions. The study was conducted in 17 hospitals led by Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
CONDITIONS
Official Title
A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by the subject's legal guardian
- Clinical diagnosis of small for gestational age infants
- Age between 6 months and 2 years (inclusive)
- Height and head circumference at or below -2 standard deviations; weight below 10th percentile for age and sex
- Total developmental quotient (GQ) less than 100 points
- Birth gestational age between 37 and less than 42 weeks, single birth, not conceived by test tube
- Symmetrical SGA with birth weight index above 2.0 (at 37 weeks) or above 2.2 (over 37 weeks)
- Normal thyroid function or normal after replacement therapy
- No previous recombinant human growth hormone treatment
You will not qualify if you...
- Abnormal liver or kidney function (ALT over twice normal, creatinine above normal)
- Severe familial short stature (father under 155cm or mother under 145cm)
- Definite neurological defects or severe developmental delay (GQ below 70), syndromes affecting cognition, or severe perinatal complications
- Genetic metabolic diseases such as congenital hypothyroidism or phenylketonuria
- Congenital skeletal dysplasia or moderate/severe scoliosis needing treatment
- Short stature caused by other known diseases including Turner, Noonan, Prader Willi, Angelman, Silver Russell syndromes or other genetic syndromes
- Diabetes or abnormal fasting blood glucose that may affect safety
- Use of hormone therapy or systemic glucocorticoids over one month within past six months (local/inhaled allowed)
- History of seizures or epilepsy unless resolved causes
- Other chronic systemic diseases
- Confirmed tumors, family history of tumors in immediate relatives, or syndromes with high tumor risk
- Known allergy to study drug
- Participation in other drug trials within past 3 months (placebo groups excluded)
- Use of drugs interfering with growth hormone secretion/effect within 3 months
- Investigator judgment deeming unsuitability for trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wuhan Tongji Hospital
Wuhan, Wuhan, China, 430000
Actively Recruiting
Research Team
X
Xiaoping Luo, director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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