Effect of Early Growth Hormone Therapy on Cognitive Development in Small for Gestational Age Infants

A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants

This study is testing if giving growth hormone shots to small infants who aren't growing well can help improve their thinking skills and overall growth.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 6 Months to 2 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Wuhan)
• Trial ID: NCT05144035 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of PEG-rhGH therapy on cognitive development in infants classified as small for gestational age (SGA) who have not shown catch-up growth. Infants aged 6 months to 2 years will be divided into two groups: one receiving weekly PEG-rhGH injections and the other receiving no treatment. The study aims to assess improvements in cognitive function and growth over a period of 104 weeks. Researchers will adjust dosages based on individual IGF-1 levels and other conditions during follow-up visits.

Who should consider this trial

Good fit: Ideal candidates are infants aged 6 months to 2 years who are diagnosed as small for gestational age and have not experienced catch-up growth.

Not a fit: Patients who are not classified as small for gestational age or those who have already shown catch-up growth may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly enhance cognitive development and growth in SGA infants, potentially improving their long-term outcomes.

How similar studies have performed: Previous studies have indicated that growth hormone treatment can improve cognitive outcomes in similar populations, suggesting a promising avenue for this approach.

Eligibility criteria

Inclusion Criteria:

1. Provide informed consent signed and dated by the subject's legal guardian;
2. The subjects met the clinical diagnosis of small for gestational age infants.
3. The age ranged from 6 months to 2 years old (including 6 months and 2 years old);
4. Height and head circumference are lower than the reference value - 2sd (including-2sd), whose weight is lower than the 10th percentile of the reference value of normal children of the same age and sex;
5. The total developmental quotient GQ calculated according to Griffiths mental development scale is less than 100 points (100 points) Indicates that the developmental age is consistent with the physiological age);
6. Birth gestational age ≥ 37 weeks and \< 42 weeks, single birth and non test tube baby;
7. Symmetrical SGA: birth weight index \> 2.0 (gestational age = 37 weeks), or \> 2.2 (gestational age \> 37 weeks) . Weight index \[birth weight (g) × 100 / birth length (CM) \];
8. Normal thyroid function or normal after replacement therapy;
9. No previous rhGH treatment

Exclusion Criteria:

1. Patients with abnormal liver and kidney function (ALT \> 2 times the upper limit of normal value, Cr \> the upper limit of normal value);
2. Severe familial dwarfism (father height \< 155cm or mother height \< 145cm);
3. Definite neurological defects and / or severe neurodevelopmental retardation (the total development quotient calculated according to Griffiths mental development scale is less than 70), definite syndrome affecting cognitive development; Severe perinatal complications (such as severe asphyxia, sepsis, necrotizing enterocolitis, respiratory distress syndrome with long-term sequelae);
4. Genetic metabolic diseases (such as congenital hypothyroidism, phenylketonuria, methylmalonic acidemia);
5. Congenital skeletal dysplasia, or moderate or above scoliosis (or scoliosis ≥ 15 °) requiring treatment or claudication;
6. Short stature with other definite causes, such as osteochondral dysplasia and Turner syndrome (TS), Noonan syndrome (NS), Prader Willi syndrome (PWS), Angelman syndrome (as), silver Russell syndrome (SRS), or other genetically confirmed syndromes (Note: diseases that meet the clinical diagnostic criteria adopt the method of clinical diagnosis; when the clinical diagnosis is difficult to be clear, or the diagnosis of the disease depends on gene screening, the method of gene diagnosis shall be supplemented / adopted);
7. patients with diabetes or fasting blood glucose are abnormal and the researchers believe that they may affect the safety of subjects.
8. Continuous application of other hormone therapy or systemic glucocorticoid therapy for more than one month in the past 6 months (local or inhaled glucocorticoids are allowed);
9. Patients with a history of convulsions or epilepsy, except for the relief or recovery of convulsions or epilepsy symptoms after the release of definite causes (such as high fever, calcium deficiency, brain infection, etc.);
10. Patients with other systemic chronic diseases;
11. Patients with confirmed tumors, or patients with family history of tumors (two or more tumor patients within three generations of immediate relatives), previous tumor history or considered as patients with high risk of tumors in combination with other information, clear syndromes with high risk of tumors (such as Bloom syndrome, Fanconi syndrome, Down syndrome, etc.);
12. Known high allergic constitution or allergic to the test drug in this study;
13. Those who have participated in clinical trials of other drugs within 3 months (the placebo group is not subject to this restriction);
14. Have received drug treatment that may interfere with GH secretion or GH effect within 3 months (including but not limited to any type of recombinant human growth hormone and protein assimilation drugs (including but not limited to oxandron, danazol and stanazol) other than rhGH injection);
15. The investigator considers that it is not suitable to be selected for this clinical trial.

Where this trial is running

Wuhan, Wuhan

• Wuhan Tongji Hospital — Wuhan, Wuhan, China (Recruiting)

Study contacts

• Principal investigator: jianwei cao, director — Zhongshan People's Hospital (Zhongshan Hospital Affiliated to Sun Yat sen University)
• Study coordinator: Xiaoping Luo, director

Conditions Small for Gestational Age Infant; Growth Hormone Treatment; Cognitive Developmental Disorder; SGA; PEG-rhGH; Cognitive developmental