CompletedPhase 3

Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

Spain78 participantsStarted 1999-04

Plain-language summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Who can participate

Age range

2 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * IUGR defined as birth length and/or weight below the lower limit (\< P10) of the Lubchenco curves for the gestational age. * Chronological age = 2-5 years * HV below average for CA * Insufficient catch-up growth (Height \< P3 for chronological age, according to Hernández) * Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother * Normal response to GH stimulation test (greater tan or equal to 10 ng/mL) * Bone age (measured through Greulich and Pyle method) less than or equal to CA Exclusion Criteria: * Children born from multiple pregnancy * Children with post-ischemic encephalopathy * Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.) * Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy) * Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....) * Nutritional disorders (celiac disease) or osteodystrophies * Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects * Abnormal karyotype * Neoplasms * Previous or ongoing chemotherapy and/or irradiation * Renal dysfunction, defined as serum creatinine \> 1 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect on Efficacy: Height SDS for chronological age

Timeframe: after 48 months

Safety: Bone maturation and glucose metabolism

Trial details

NCT IDNCT00184691

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-06

View on ClinicalTrials.gov More Foetal Growth Problem trials