Infant, Small for Gestational AgePhase 2hGHNCT02326610
Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
A Phase 2 study testing Human growth hormone,ZOMACTON® (somatropin) in people with Infant, Small for Gestational Age and Growth Hormone Treatment, run by Tel-Aviv Sourasky Medical Center.
Trial summary
SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency. Up to 1/4 of children born SGA have neurodevelopmental deficits. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Infant, Small for Gestational Age, Growth Hormone Treatment, Infant, Premature, Diseases
- What is being tested?
- Human growth hormone,ZOMACTON® (somatropin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2018
- Phase
- Phase 2
- 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 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Symmetrical small for gestational age at birth: weight + length+ head circumference below -2 SD for gestational age.
- Birth weight of 1200-2200 gr
- Follow-up of growth until age of 6-12 months
- Growth parameters below -2 SD at age of 6-12 months and absence of sufficient catch-up.
- Low growth hormone levels.
Who cannot join
- Chromosomal aberration
- Any congenital syndrome and any syndrome that shows a tendency to uncontrolled cell growth and to develop tumors
- Major congenital malformation (affecting growth or development)
- Congenital infection
- Exposure to teratogenic drugs or drugs affecting development during pregnancy
- Maternal drug or alcohol abuse.
- Maternal cancer as well as cancer in 1st degree relatives.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency.
Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits
Read more
To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months.
The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects.
The study will take place at the Tel Aviv Medical Center only.
- Being tested
- Human growth hormone,ZOMACTON® (somatropin)
- Keywords
- Small for gestational age (SGA), Human growth hormone (hGH)
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human growth hormone,ZOMACTON® (somatropin)Drug
The initial dose will be 30µg/kg/day. The maximal dose will be 40µg/kg/day. The dose will be adjusted by monitoring the serum IGF-I level. Growth hormone will be delivered by injection.
| Study group | Role | What they receive |
|---|---|---|
| hGH, ZOMACTON® (somatropin) | Active comparator | For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection Receives: Drug: Human growth hormone,ZOMACTON® (somatropin) |
| No human growth hormone | No intervention | No growth hormone is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)
using the Bayley Scales of Infant Development (BSID-III)
Measured: Before treatment and 1 year later
Changes in Neurological status (formal neurological examination)
using formal neurological examination
Measured: Before treatment and 1 year later
Secondary outcomes (3)
Changes in X-ray of the hand and wrist
Measured: Before treatment and 1 year later
Pediatric Quality of life Inventory: the PedsQL measure
Measured: after 1 year of treatment
Achenbach Child Behavior Checklist (CBCL)
Measured: at the end of study after 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Small for Gestational AgeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dror Mandel, MD, Principal investigator, Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326610
- Sponsor's protocol ID
- TASMC-14-DM-0713-12-TLV
- Acronym
- hGH
- Status last verified
- Dec 2014
- First submitted
- 26 Nov 2014
- Last updated
- 29 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
- ClinicalTrials.gov ID
- NCT02326610
- Acronym / sponsor ID
- hGH / TASMC-14-DM-0713-12-TLV
- Keywords
- Small for gestational age (SGA), Human growth hormone (hGH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Dec 2014 (estimated)
- 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.
SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency.
Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits
To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months.
The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects.
The study will take place at the Tel Aviv Medical Center only.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hGH, ZOMACTON® (somatropin) | Active comparator | Drug: Human growth hormone,ZOMACTON® (somatropin)For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection |
| No human growth hormone | No intervention | –No growth hormone is given. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Symmetrical small for gestational age at birth: weight + length+ head circumference below -2 SD for gestational age.
- Birth weight of 1200-2200 gr
- Follow-up of growth until age of 6-12 months
- Growth parameters below -2 SD at age of 6-12 months and absence of sufficient catch-up.
- Low growth hormone levels.
Key exclusion criteria (7 listed)
- Chromosomal aberration
- Any congenital syndrome and any syndrome that shows a tendency to uncontrolled cell growth and to develop tumors
- Major congenital malformation (affecting growth or development)
- Congenital infection
- Exposure to teratogenic drugs or drugs affecting development during pregnancy
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 |
|---|---|---|
| Human growth hormone,ZOMACTON® (somatropin)The initial dose will be 30µg/kg/day. The maximal dose will be 40µg/kg/day. The dose will be adjusted by monitoring the serum IGF-I level. Growth hormone will be delivered by injection. | Drug | hGH, ZOMACTON® (somatropin) |
Primary outcome
Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)
Time frame: Before treatment and 1 year later
using the Bayley Scales of Infant Development (BSID-III)
Changes in Neurological status (formal neurological examination)
Time frame: Before treatment and 1 year later
using formal neurological examination
3 secondary outcomes
Changes in X-ray of the hand and wrist
Time frame: Before treatment and 1 year later
Pediatric Quality of life Inventory: the PedsQL measure
Time frame: after 1 year of treatment
Achenbach Child Behavior Checklist (CBCL)
Time frame: at the end of study after 1 year of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2014.
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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.
Dror Mandel, MD principal investigator
Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human growth hormone,ZOMACTON® (somatropin) in people with Infant, Small for Gestational Age and Growth Hormone Treatment, run by Tel-Aviv Sourasky Medical Center.
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 5 inclusion and 7 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 29 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dror Mandel, MD (+97236925690, drorm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III) (time frame: Before treatment and 1 year later). 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 29 Dec 2014.