MedDataX Logo

Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

NCT ID: NCT02326610

Last Updated: 2014-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant, Small for Gestational Age Growth Hormone Treatment Infant, Premature, Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Small for gestational age (SGA) Human growth hormone (hGH)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hGH, ZOMACTON® (somatropin)

For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection

Group Type ACTIVE_COMPARATOR

Human growth hormone,ZOMACTON® (somatropin)

Intervention Type 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.

No human growth hormone

No growth hormone is given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dror Mandel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dror Mandel, MD

Role: CONTACT

Phone: +97236925690

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TASMC-14-DM-0713-12-TLV

Identifier Type: -

Identifier Source: org_study_id