Small for Gestational Age InfantPhase 4NCT05144035
A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants
A Phase 4 study testing PEG-rhGH in people with Small for Gestational Age Infant and Growth Hormone Treatment, run by Tongji Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Small for Gestational Age Infant, Growth Hormone Treatment, Cognitive Developmental Disorder
- What is being tested?
- PEG-rhGH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2022to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provide informed consent signed and dated by the subject's legal guardian;
- The subjects met the clinical diagnosis of small for gestational age infants.
- The age ranged from 6 months to 2 years old (including 6 months and 2 years old);
- 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;
- 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);
- Birth gestational age ≥ 37 weeks and < 42 weeks, single birth and non test tube baby;
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- 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) ];
- Normal thyroid function or normal after replacement therapy;
- No previous rhGH treatment
Who cannot join
- Patients with abnormal liver and kidney function (ALT > 2 times the upper limit of normal value, Cr > the upper limit of normal value);
- Severe familial dwarfism (father height < 155cm or mother height < 145cm);
- 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);
- Genetic metabolic diseases (such as congenital hypothyroidism, phenylketonuria, methylmalonic acidemia);
- Congenital skeletal dysplasia, or moderate or above scoliosis (or scoliosis ≥ 15 °) requiring treatment or claudication;
- 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);
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- patients with diabetes or fasting blood glucose are abnormal and the researchers believe that they may affect the safety of subjects.
- 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);
- 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.);
- Patients with other systemic chronic diseases;
- 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.);
- Known high allergic constitution or allergic to the test drug in this study;
- Those who have participated in clinical trials of other drugs within 3 months (the placebo group is not subject to this restriction);
- 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);
- The investigator considers that it is not suitable to be selected for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Tongji Hospital
Wuhan, Wuhan, 430000
xiaoping luo, Ph.D
About this study
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.
Read more
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
Read the detailed description
Subjects: SGA children from 6 months to 2 years old who meet the enrollment conditions shall be informed of the enrollment by the researcher and the subject's guardian, and the subject's guardian shall decide to participate in the test drug group or the control group.
GH treatment group (n = 68): the subjects were given PEG-rhGH injection 0.2 mg / kg / week (initial dose), once a week, subcutaneously before going to bed for 104 weeks. Each follow-up, the researchers adjusted the dosage according to the IGF-1 results of the center and other individual conditions.
Control group (n = 68): no treatment, only follow-up examination and growth and development related evaluation, and the follow-up time was 104 Week.
- Conditions
- Small for Gestational Age Infant, Growth Hormone Treatment, Cognitive Developmental Disorder
- Being tested
- PEG-rhGH
- Keywords
- SGA, PEG-rhGH, Cognitive developmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhGHDrug
Also called jintrolong
the subjects were given PEG-rhGH injection 0.2 mg / kg / week (initial dose), once a week, subcutaneously before going to bed for 104 weeks. Each follow-up, the researchers adjusted the dosage according to the IGF-1 results of the center and other individual conditions.
| Study group | Role | What they receive |
|---|---|---|
| GH treatment group | Experimental | GH treatment group (n = 68): the subjects were given PEG-rhGH injection 0.2 mg / kg / week (initial dose), once a week, subcutaneously before going to bed for 104 weeks. Each follow-up, the researchers adjusted the dosage according to the IGF-1 results of the center and other individual conditions. Receives: Drug: PEG-rhGH |
| Control group | No intervention | Control group (n = 68): no treatment, only follow-up examination and growth and development related evaluation, and the follow-up time was 104 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total development quotient (GQ)
The changes of total development quotient (GQ) of young SGA children were calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
Measured: 104 weeks
head circumference SDS
Changes of head circumference SDS in young SGA children before and after treatment
Measured: 104 weeks
Secondary outcomes (13)
Motor domain development quotient
Changes of motor domain development quotient (AQ) calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
Measured: 104 weeks
Personal and social domain development quotient
Changes of personal and social domain development quotient (BQ) calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
Measured: 104 weeks
Hearing and language domain development quotient
Changes of hearing and language domain development quotient (CQ) calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
Measured: 104 weeks
Hand eye coordination domain development quotient
Changes of hand eye coordination domain development quotient (DQ) calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
Measured: 104 weeks
Operation domain development quotient
Changes of operation domain development quotient (EQ) calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
Measured: 104 weeks
Reasoning domain development quotient
Changes of reasoning domain development quotient (FQ) calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
Measured: 104 weeks
Total T-scores and T-scores of behavior factors according to Achenbach children's behavior scale (CBCL).(The normal value is 100 points. The higher the score, the better)
Changes of total T-scores and T-scores of behavior factors calculated according to Achenbach children's behavior scale (CBCL) before and after treatment.(The normal value range is 55-70 points, and the lower the score, the better)
Measured: 104 weeks
The adaptive behavior scale (ABAS-II) before and after treatment (GAC score) and three domain scores (cognitive skills, social skills and practical skills)
The adaptive comprehensive score was calculated according to the adaptive behavior scale (ABAS-II) before and after treatment.
(The normal value is 100 points. The higher the score, the better)
Measured: 104 weeks
height SDS
Changes of height SDS in young SGA children before and after treatment
Measured: 104 weeks
Brain tissue metabolites
Brain tissue metabolites measured by cranial magnetic resonance spectroscopy (MRS) before and after treatment.
Measured: 104 weeks
Myelin maturation
Myelin maturation was evaluated by diffusion tensor imaging (DTI) before and after treatment.
Measured: 104 weeks
Brain volume and brain structure (Development)
Three dimensional T1 weighted imaging (3D) was performed before and after treatment T1WI) to assess brain volume and brain structure (Development).
Measured: 104 weeks
Security
Related adverse reactions during the study
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start6 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational Age InfantStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Xiaoping Luo, Tongji Hospital
- Investigators
- jianwei cao, director, Principal investigator, Zhongshan People's Hospital (Zhongshan Hospital Affiliated to Sun Yat sen University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144035
- Sponsor's protocol ID
- Gensci-GH-21005
- Status last verified
- Apr 2023
- First submitted
- 17 Oct 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants
- ClinicalTrials.gov ID
- NCT05144035
- Acronym / sponsor ID
- Gensci-GH-21005
- Conditions
- Small for Gestational Age Infant, Growth Hormone Treatment, Cognitive Developmental Disorder
- Keywords
- SGA, PEG-rhGH, Cognitive developmental
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Subjects: SGA children from 6 months to 2 years old who meet the enrollment conditions shall be informed of the enrollment by the researcher and the subject's guardian, and the subject's guardian shall decide to participate in the test drug group or the control group.
GH treatment group (n = 68): the subjects were given PEG-rhGH injection 0.2 mg / kg / week (initial dose), once a week, subcutaneously before going to bed for 104 weeks. Each follow-up, the researchers adjusted the dosage according to the IGF-1 results of the center and other individual conditions.
Control group (n = 68): no treatment, only follow-up examination and growth and development related evaluation, and the follow-up time was 104 Week.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH treatment group | Experimental | Drug: PEG-rhGHGH treatment group (n = 68): the subjects were given PEG-rhGH injection 0.2 mg / kg / week (initial dose), once a week, subcutaneously before going to bed for 104 weeks. Each follow-up, the researchers adjusted the dosage according to the IGF-1 results of the center and other individual conditions. |
| Control group | No intervention | –Control group (n = 68): no treatment, only follow-up examination and growth and development related evaluation, and the follow-up time was 104 weeks. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Provide informed consent signed and dated by the subject's legal guardian;
- The subjects met the clinical diagnosis of small for gestational age infants.
- The age ranged from 6 months to 2 years old (including 6 months and 2 years old);
- 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;
- 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);
Key exclusion criteria (15 listed)
- Patients with abnormal liver and kidney function (ALT > 2 times the upper limit of normal value, Cr > the upper limit of normal value);
- Severe familial dwarfism (father height < 155cm or mother height < 145cm);
- 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);
- Genetic metabolic diseases (such as congenital hypothyroidism, phenylketonuria, methylmalonic acidemia);
- Congenital skeletal dysplasia, or moderate or above scoliosis (or scoliosis ≥ 15 °) requiring treatment or claudication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-rhGHAlso: jintrolongthe subjects were given PEG-rhGH injection 0.2 mg / kg / week (initial dose), once a week, subcutaneously before going to bed for 104 weeks. Each follow-up, the researchers adjusted the dosage according to the IGF-1 results of the center and other individual conditions. | Drug | GH treatment group |
Primary outcome
total development quotient (GQ)
Time frame: 104 weeks
The changes of total development quotient (GQ) of young SGA children were calculated according to Griffiths mental development scale before and after treatment.（The Griffiths Scales,The normal range is from the 16th percentile to the 84th percentile of children of the same age. 100 is the mean. The higher the score, the better）
head circumference SDS
Time frame: 104 weeks
Changes of head circumference SDS in young SGA children before and after treatment
13 secondary outcomes
Motor domain development quotient
Time frame: 104 weeks
Personal and social domain development quotient
Time frame: 104 weeks
Hearing and language domain development quotient
Time frame: 104 weeks
Hand eye coordination domain development quotient
Time frame: 104 weeks
Operation domain development quotient
Time frame: 104 weeks
Reasoning domain development quotient
Time frame: 104 weeks
Total T-scores and T-scores of behavior factors according to Achenbach children's behavior scale (CBCL).(The normal value is 100 points. The higher the score, the better)
Time frame: 104 weeks
The adaptive behavior scale (ABAS-II) before and after treatment (GAC score) and three domain scores (cognitive skills, social skills and practical skills)
Time frame: 104 weeks
height SDS
Time frame: 104 weeks
Brain tissue metabolites
Time frame: 104 weeks
Myelin maturation
Time frame: 104 weeks
Brain volume and brain structure (Development)
Time frame: 104 weeks
Security
Time frame: 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jianwei cao, director principal investigator
Zhongshan People's Hospital (Zhongshan Hospital Affiliated to Sun Yat sen University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-rhGH in people with Small for Gestational Age Infant and Growth Hormone Treatment, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Luo, director (13387522645, xpluo@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total development quotient (GQ) (time frame: 104 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.