Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age (AGA)

Pfizer

Status and phase

Completed

Phase 2

Conditions

Infant, Very Low Birth Weight

Growth Hormone Therapy

Treatments

Drug: Somatropin

Other: Control Arm

Study type

Interventional

Funder types

Industry

Identifiers

NCT00174460

A6281273

Details and patient eligibility

About

Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.

Enrollment

33 patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
Girls: Tanner stage 1 breast development
Boys: Testis volume <= 3ml
Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
(In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the subject is still pubertal.)
Height <=-2 SD for chronological age (Brandt/Reinken).
Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3 months observation period before screening).
Premature born defined as <=1500 g birth weight.
GH sufficiency (GH level > 7 ug/l following any routine GH stimulation test).
Written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information.

Exclusion criteria

Subjects presenting with any of the following will not be included in the trial:

Other endocrine diseases except for well substituted hypothyroidism.
Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
Positive GAD and IA-2 antibodies (for type 1 diabetes).
History of malignancy
Children who meet all of the following 4 criteria:
actual body height < -2,5 SDS (Brandt/Reinken) and parent adjusted target height < -1 SDS (Hermanussen and Cole, 2003)
length and/or body weight retardations adjusted to gestational age at birth < -2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
children with chronological age > = 4 years and
growth velocity < 0 SDS during the last year before inclusion.
Chromosomal aberrations or syndromes.
Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).
Severe hemiparesis and severe CNS defects
Retinopathia > third degree or laser treatment as newborns.
Participation in any other clinical trial during active treatment phase.
Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.