Clinical Trials Logo

Clinical Trial Summary

This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.


Clinical Trial Description

The term "small for gestational age" (SGA) is a pathological medical condition known since about two decades supported by two consensus conferences of 2001. It inhibits the height and/or weight of the child at birth without prejudging the mechanisms that alter these. This study will be carried out by hospital pediatricians, endocrinologists or physicians in private, mixed private and hospital practice in metropolitan France. Subjects will be monitored by doctors in accordance with the normal scope of follow-up of pathology until their final growth and until they reach adult height and/or until the treatment is discontinued. The participating doctors will include all the short SGA subjects coming for consultation or the follow-up (for less than 12 months) of their treatment by Saizen in this study. The inclusions will take place over a period of 21 months.

OBJECTIVES

Primary objective:

- To describe the characteristics of short children born SGA (SGA subjects) treated with Saizen

Secondary objectives:

- To describe the terms and conditions for the prescription of Saizen in terms of dosage, duration of treatment, reason for discontinuation and compliance

- To describe the effects of Saizen on growth and final height

- To describe the tolerance of Saizen. For each subject and during each visit, the participating doctor will complete an electronic data collection form. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Infant, Small for Gestational Age

NCT number NCT01082354
Study type Observational
Source Merck KGaA
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date December 2015

See also
  Status Clinical Trial Phase
Completed NCT01196156 - Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT05217186 - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Completed NCT03082313 - Movement-based Infant Intervention N/A
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Completed NCT01203423 - Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Active, not recruiting NCT01995968 - Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate. N/A
Completed NCT03726697 - Effect of Tahneek on Hypoglycemia in Newborn Infants N/A
Completed NCT01223287 - Physiologic Definition of Bronchopulmonary Dysplasia N/A
Active, not recruiting NCT05343403 - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Withdrawn NCT04360967 - SURF, Neurodevelopment, Growth Study in SGA Infants N/A
Completed NCT00109525 - Early Diagnosis of Candidiasis in Premature Infants
Completed NCT00067613 - Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia N/A
Completed NCT01223261 - Observational Study of Surgical Treatment of Necrotizing Enterocolotis
Recruiting NCT04367181 - DCS Study in Extremely Premature Newborns N/A
Completed NCT02377817 - Halifax PrenaBelt Trial N/A
Completed NCT00349726 - Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants Phase 2
Completed NCT01222364 - Delayed Cord Clamping in VLBW Infants Phase 1/Phase 2