Trial · NCT00809055

MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine

NCT00809055, Phase 4, Completed, Washington University School of Medicine; results first posted 2016-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine. Trials, record NCT00809055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00809055

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Trial

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

Title: MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
NCT number: NCT00809055
Status: Completed
Phases: Phase 4
Enrollment: 74 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Apnea of Prematurity, Intraventricular Hemorrhage, Brain Injury
Interventions: Caffeine citrate
First posted: 2008-12-16
Last updated: 2016-02-24
Results first posted: 2016-02-24

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	White Matter Microstructural Maturation	Participants were followed for the duration of hospital stay, an average of 12 weeks	Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI.
Secondary	Mortality Rates	Participants were followed for the duration of hospital stay, an average of 12 weeks
Secondary	Cerebellar Hemorrhage	Participants were followed for the duration of hospital stay, an average of 12 weeks
Secondary	Length of Time Requiring Invasive Respiratory Support	Participants were followed for the duration of hospital stay, an average of 12 weeks
Secondary	Rates of Chronic Lung Disease	Participants were followed for the duration of hospital stay, an average of 12 weeks	Defined as oxygen requirement at 36 weeks PMA
Secondary	Rates of Necrotizing Enterocolitis	Participants were followed for the duration of hospital stay, an average of 12 weeks
Secondary	Rates of Retinopathy of Prematurity	Participants were followed for the duration of hospital stay, an average of 12 weeks
Secondary	Evaluation of EEG Seizure Burden	First 72 hours of life	For the first 72 hours of life, infants were monitored for seizures using continuous limited channel aEEG. Seizures were defined as a series of sharp waves, at least ten seconds in duration, which evolve in frequency, amplitude, and morphology over time and are clearly distinguishable from the background or artifact.
Secondary	Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge	Participants were followed for the duration of hospital stay, an average of 12 weeks	The Dubowitz Neurologic Examination is a standardized neurologic examination for infants at term age. It includes 6 compound optimality scores summed to obtain the total optimality score. Compound optimality scores include tone (range 0-10), tone pattern (range 0-5), reflexes (range 0-6), movements (range 0-3), abnormal signs (range 0-3), and behavior (range 0-7). The range for the compound optimality score is 0 - 34, with scores between 30.5 and 34 considered optimal and scores below 30.5 considered suboptimal.
Secondary	Bayley Scales of Infant Development Cognitive Score at 2 Years of Age	2 years	The cognitive portion of the Bayley Scales of Infant Development assesses development in infants and toddlers between the ages of 0 and 3 years. Raw scores are converted to scale scores. A scale score of 100 is designed to represent the population mean. Scores below 100 represent developmental delay relative to the mean and scores above 100 represent advanced development relative to the mean.

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	White Matter Microstructural Maturation	Participants were followed for the duration of hospital stay, an average of 12 weeks	12 patients excluded from high-dose group (7 died, 2 withdrew, 3 insufficient image quality). 10 patients excluded from standard-dose group (5 died, 1 transferred, 1 parent refused MRI, 3 insufficient image quality).	apparent diffusion coefficient	MEAN
SECONDARY	Mortality Rates	Participants were followed for the duration of hospital stay, an average of 12 weeks		participants	NUMBER
SECONDARY	Cerebellar Hemorrhage	Participants were followed for the duration of hospital stay, an average of 12 weeks		participants	NUMBER
SECONDARY	Length of Time Requiring Invasive Respiratory Support	Participants were followed for the duration of hospital stay, an average of 12 weeks		days	MEDIAN
SECONDARY	Rates of Chronic Lung Disease	Participants were followed for the duration of hospital stay, an average of 12 weeks		participants	NUMBER
SECONDARY	Rates of Necrotizing Enterocolitis	Participants were followed for the duration of hospital stay, an average of 12 weeks		participants	NUMBER
SECONDARY	Rates of Retinopathy of Prematurity	Participants were followed for the duration of hospital stay, an average of 12 weeks		participants	NUMBER
SECONDARY	Evaluation of EEG Seizure Burden	First 72 hours of life	7 patients excluded from high-dose group and 8 from standard-dose group due to recordings \< 6 hours or corrupt data files.	seconds	MEAN
SECONDARY	Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge	Participants were followed for the duration of hospital stay, an average of 12 weeks	9 patients excluded from high-dose group (7 died, 2 withdrew). 6 patients excluded from standard-dose group (5 died, 1 transferred).	scores on a scale	MEAN
SECONDARY	Bayley Scales of Infant Development Cognitive Score at 2 Years of Age	2 years	13 patients excluded from high-dose group (7 died, 2 withdrew, 2 we were unable to contact, 2 did not comply with scheduled appointments). 15 patients excluded from standard-dose group (5 died, 2 withdrew, 5 we were unable to contact, 3 did not comply with scheduled appointments).	score	MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
White Matter Microstructural Maturation	High Dose Caffeine	1.43	Standard Deviation 0.07	apparent diffusion coefficient
White Matter Microstructural Maturation	Standard Dose Caffeine	1.42	Standard Deviation 0.09	apparent diffusion coefficient
Mortality Rates	High Dose Caffeine	7		participants
Mortality Rates	Standard Dose Caffeine	5		participants
Cerebellar Hemorrhage	High Dose Caffeine	10		participants
Cerebellar Hemorrhage	Standard Dose Caffeine	3		participants
Length of Time Requiring Invasive Respiratory Support	High Dose Caffeine	4	Inter-Quartile Range 1 to 22	days
Length of Time Requiring Invasive Respiratory Support	Standard Dose Caffeine	3	Inter-Quartile Range 1 to 22	days
Rates of Chronic Lung Disease	High Dose Caffeine	19		participants
Rates of Chronic Lung Disease	Standard Dose Caffeine	18		participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	High Dose Caffeine	37
Overall Study	STARTED	Standard Dose Caffeine	37
Overall Study	COMPLETED	High Dose Caffeine	28
Overall Study	COMPLETED	Standard Dose Caffeine	30
Overall Study	NOT COMPLETED	High Dose Caffeine	9
Overall Study	NOT COMPLETED	Standard Dose Caffeine	7

Source ClinicalTrials.gov

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	High Dose Caffeine
Total, all-cause mortality	Standard Dose Caffeine
Total, other adverse events	High Dose Caffeine	0	37
Total, other adverse events	Standard Dose Caffeine	0	37
Total, serious adverse events	High Dose Caffeine	0	37
Total, serious adverse events	Standard Dose Caffeine	0	37

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD057098	UNDERSTANDING NEUROBEHAVIORAL DEFICITS IN PRETERM INFANTS THROUGH IMAGING	INDER, TERRIE E; NEIL, JEFFREY J.; VAN ESSEN, DAVID C	WASHINGTON UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2008 to 2012

Source NIH RePORTER

Trial comparisons6

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

Comparison	Source
High Dose Caffeine vs Standard Dose Caffeine: Mortality Rates	Trial comparisons
High Dose Caffeine vs Standard Dose Caffeine: Rates of Chronic Lung Disease	Trial comparisons
High Dose Caffeine vs Standard Dose Caffeine: Rates of Necrotizing Enterocolitis	Trial comparisons
High Dose Caffeine vs Standard Dose Caffeine: Cerebellar Hemorrhage	Trial comparisons
High Dose Caffeine vs Standard Dose Caffeine: Rates of Retinopathy of Prematurity	Trial comparisons
High Dose Caffeine vs Standard Dose Caffeine: serious adverse events	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.

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