Trial · NCT00174460

Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

NCT00174460, Phase 2, Completed, Pfizer; results first posted 2009-05-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age. Trials, record NCT00174460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174460

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
NCT number: NCT00174460
Status: Completed
Phases: Phase 2
Enrollment: 33 participants, actual
Lead sponsor: Pfizer
Conditions: Growth Hormone Therapy, Infant, Very Low Birth Weight
Interventions: Somatropin, Control Arm
First posted: 2005-09-15
Last updated: 2017-04-05
Results first posted: 2009-05-12
Limitations and caveats: Result values for the primary outcome measures were revised at the final analysis due to programmatic corrections: age rounded up if \>6 months past last birthday. Height and height SDS not rounded for final analysis; rounded only for the reports.

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Height Standard Deviation Score (SDS) After 1 Year	Baseline to 1 year (Month 12)	Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Primary	Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year	Baseline to 1 year (Month 12)	Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Secondary	Change From Baseline in Growth Velocity After 1 Year and After 2 Years	Baseline, Month 12, Month 24	Growth velocity measured as centimeters per year.
Secondary	Change From Baseline in Growth Velocity SDS After 2 Years	Baseline, Month 24	Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Secondary	Change From Baseline in Height After 1 Year and After 2 Years	Baseline, Month 12, Month 24
Secondary	Change From Baseline in Height SDS After 2 Years	Baseline, Month 24	Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Secondary	Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps	Baseline, Month 12, Month 24	Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.
Secondary	Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular	Baseline, Month 12, Month 24	Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.
Secondary	Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac	Baseline, Month 12, Month 24	Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.
Secondary	Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years	Baseline, Month 12, Month 24	Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Height Standard Deviation Score (SDS) After 1 Year	Baseline to 1 year (Month 12)	Full Analysis Set (FAS; all randomized subjects who had at least 1 post-baseline efficacy measurement); Control group received Somatropin from Month 12 onwards.	centimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Growth Velocity After 1 Year and After 2 Years	Baseline, Month 12, Month 24	FAS; Control group received Somatropin from Month 12 onwards.	centimeters per year	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Growth Velocity SDS After 2 Years	Baseline, Month 24	FAS; Control group received Somatropin from Month 12 onwards.	centimeters per year	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Height After 1 Year and After 2 Years	Baseline, Month 12, Month 24	FAS; Control group received Somatropin from Month 12 onwards.	centimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Height SDS After 2 Years	Baseline, Month 24	FAS; Control group received Somatropin from Month 12 onwards.	centimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps	Baseline, Month 12, Month 24	FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.	millimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular	Baseline, Month 12, Month 24	FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.	millimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac	Baseline, Month 12, Month 24	FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.	millimeters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years	Baseline, Month 12, Month 24	FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.	z-score	LEAST_SQUARES_MEAN
PRIMARY	Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year	Baseline to 1 year (Month 12)	FAS; Control group received Somatropin from Month 12 onwards.	centimeters per year	LEAST_SQUARES_MEAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Height Standard Deviation Score (SDS) After 1 Year	Somatropin		1.099	Standard Error 0.0714	centimeters
Change in Height Standard Deviation Score (SDS) After 1 Year	Control Arm		0.108	Standard Error 0.0783	centimeters
Change From Baseline in Growth Velocity After 1 Year and After 2 Years	Somatropin	Month 12	5.110	Standard Error 0.2623	centimeters per year
Change From Baseline in Growth Velocity After 1 Year and After 2 Years	Control Arm	Month 12	0.695	Standard Error 0.2881	centimeters per year
Change From Baseline in Growth Velocity After 1 Year and After 2 Years	Somatropin	Month 24	3.049	Standard Error 0.3546	centimeters per year
Change From Baseline in Growth Velocity After 1 Year and After 2 Years	Control Arm	Month 24	3.934	Standard Error 0.3893	centimeters per year
Change From Baseline in Growth Velocity SDS After 2 Years	Somatropin		4.751	Standard Error 0.4716	centimeters per year
Change From Baseline in Growth Velocity SDS After 2 Years	Control Arm		5.825	Standard Error 0.5177	centimeters per year
Change From Baseline in Height After 1 Year and After 2 Years	Somatropin	Month 12	10.467	Standard Error 0.2439	centimeters
Change From Baseline in Height After 1 Year and After 2 Years	Control Arm	Month 12	5.927	Standard Error 0.2677	centimeters

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Somatropin	18
Overall Study	STARTED	Control Arm	15
Overall Study	Received Study Treatment	Somatropin	18
Overall Study	Received Study Treatment	Control Arm	14
Overall Study	COMPLETED	Somatropin	18
Overall Study	COMPLETED	Control Arm	14
Overall Study	NOT COMPLETED	Somatropin	0
Overall Study	NOT COMPLETED	Control Arm	1

Source ClinicalTrials.gov

Adverse events88

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Autoimmune thyroiditis	Endocrine disorders	Somatropin	0	18
other	Autoimmune thyroiditis	Endocrine disorders	Control Arm	1	15
other	Hypothyroidism	Endocrine disorders	Somatropin	1	18
other	Hypothyroidism	Endocrine disorders	Control Arm	1	15
other	Visual impairment	Eye disorders	Somatropin	0	18
other	Visual impairment	Eye disorders	Control Arm	1	15
other	Inguinal hernia	Gastrointestinal disorders	Somatropin	1	18
other	Inguinal hernia	Gastrointestinal disorders	Control Arm	0	15
other	Tooth disorder	Gastrointestinal disorders	Somatropin	1	18
other	Tooth disorder	Gastrointestinal disorders	Control Arm	0	15

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Somatropin
Total, all-cause mortality	Control Arm
Total, other adverse events	Somatropin	13	18
Total, other adverse events	Control Arm	11	15
Total, serious adverse events	Somatropin	5	18
Total, serious adverse events	Control Arm	1	15

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Somatropin vs Control Arm: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00174460

GET https://conductscience.org/api/trials/v1/NCT00174460/registered?page=2

API reference For AI assistants