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
25 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
Researchers are studying the effects of growth hormone treatment on cognitive development and growth in infants born small for gestational age (SGA) who have not caught up in height or head circumference by the age of 6 months to 2 years. This study aims to evaluate whether early treatment with PEG-rhGH can improve IQ, behavior, and self-cognition in these children, as well as promote catch-up growth, especially during the critical developmental period before age two. Participants are assigned either to a treatment group receiving PEG-rhGH injections at an initial dose of 0.2 mg/kg once weekly by subcutaneous injection at bedtime for 104 weeks, with dosage adjustments based on IGF-1 levels, or to a control group that receives no treatment but undergoes the same follow-up assessments over the 104-week period. This non-randomized study compares growth and cognitive development outcomes between these two groups. Throughout the study, children will be monitored regularly for growth parameters including head circumference and height, as well as cognitive, motor, social, and behavioral development using standardized scales like the Griffiths mental development scale and the Achenbach children’s behavior scale. The study also evaluates brain structure and function through imaging and metabolic assessments, and safety is closely tracked over the two years of participation.
CONDITIONS
Brief 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 from the legal guardian
- Clinical diagnosis of small for gestational age infants
- Age between 6 months and 2 years inclusive
- Height and head circumference below -2 standard deviations, weight below the 10th percentile for age and sex
- Total developmental quotient (GQ) less than 100 points
- Birth gestational age between 37 and 42 weeks, single birth, not conceived by assisted reproduction
- Symmetrical SGA as defined by birth weight index criteria
- Normal thyroid function or normal after replacement therapy
- No previous treatment with recombinant human growth hormone
You will not qualify if you...
- Abnormal liver or kidney function
- Severe familial dwarfism (father height < 155cm or mother height < 145cm)
- Severe neurological defects or developmental retardation (GQ less than 70), syndromes affecting cognitive development, or severe perinatal complications
- Genetic metabolic diseases such as congenital hypothyroidism or phenylketonuria
- Congenital skeletal dysplasia or moderate to severe scoliosis requiring treatment
- Short stature caused by other definite conditions like Turner syndrome, Prader Willi syndrome, or genetically confirmed syndromes
- Diabetes or abnormal fasting blood glucose affecting safety
- Recent hormone or systemic glucocorticoid therapy exceeding one month in past six months
- History of seizures or epilepsy except resolved causes
- Other systemic chronic diseases
- Confirmed tumors or family history indicating high tumor risk
- Known allergy to the study drug
- Participation in other drug clinical trials within past three months
- Recent use of drugs interfering with growth hormone secretion or effect
- Investigator's judgment deeming unsuitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 104 weeks
Participants in the treatment group receive weekly PEG-rhGH injections subcutaneously before bedtime, with dose adjustments based on IGF-1 levels and individual conditions.
Weekly visits for dose adjustment and monitoring
Duration - 104 weeks
Participants in the control group are observed without treatment and undergo follow-up examinations and growth and development evaluations.
Regular follow-up visits during study period
Trial Site Locations
Total: 1 location
1
Wuhan Tongji Hospital
Wuhan, Wuhan, China, 430000
Actively Recruiting
Research Team
X
Xiaoping Luo, director
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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