Trial · NCT01751724

Caffeine to Reduce Mechanical Ventilation in Preterm Infants

NCT01751724, Not applicable, Terminated, University of Miami; results first posted 2017-06-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Caffeine to Reduce Mechanical Ventilation in Preterm Infants. Trials, record NCT01751724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01751724

On this page

Trial

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

Title: Caffeine to Reduce Mechanical Ventilation in Preterm Infants
NCT number: NCT01751724
Status: Terminated
Phases: Not applicable
Enrollment: 87 participants, actual
Lead sponsor: University of Miami
Conditions: Prematurity, Apnea, Respiratory Failure
Interventions: Caffeine citrate, Normal saline
First posted: 2012-12-18
Last updated: 2017-06-19
Results first posted: 2017-06-19

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Age at First Successful Extubation	From birth to until 36 weeks postmenstrual age	Defined as age of extubation with infant remaining extubated for more than 24 hours.
Secondary	Survival	From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death
Secondary	Total Duration of Mechanical Ventilation	From the time of first intubation until the last extubation, up to 36 weeks corrected age
Secondary	Total Duration of Oxygen Supplementation	From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age
Secondary	Number of Infants With Bronchopulmonary Dysplasia (BPD)	Evaluated at 36 weeks corrected postmenstrual age	BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.
Secondary	Survival Without BPD	From the time of randomization until 36 weeks corrected age, discharge or death	Discharge alive without BPD. BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.
Other	Number of Infants With Pulmonary Hemorrhage	From enrollment until 36 weeks postmenstrual age, discharge or death
Other	Number of Infants With Necrotizing Enterocolitis	From enrollment until 36 weeks postmenstrual age, discharge or death
Other	Number of Infants With Septicemia	From enrollment until 36 weeks postmenstrual age, discharge or death	Septicemia defined as positive blood culture
Other	Number of Infants With Severe Intraventricular Hemorrhage	From enrollment until 36 weeks postmenstrual age, discharge or death	Severe intraventricular hemorrhage defined as grade III or higher

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Age at First Successful Extubation	From birth to until 36 weeks postmenstrual age		days	MEDIAN
SECONDARY	Survival	From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Total Duration of Mechanical Ventilation	From the time of first intubation until the last extubation, up to 36 weeks corrected age	Infants alive at 36 weeks postmenstrual age	days	MEDIAN
SECONDARY	Total Duration of Oxygen Supplementation	From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age	Infants alive at 36 weeks postmenstrual age	days	MEDIAN
SECONDARY	Number of Infants With Bronchopulmonary Dysplasia (BPD)	Evaluated at 36 weeks corrected postmenstrual age	Infants alive at 36 weeks postmenstrual age	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Survival Without BPD	From the time of randomization until 36 weeks corrected age, discharge or death		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Infants With Pulmonary Hemorrhage	From enrollment until 36 weeks postmenstrual age, discharge or death		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Infants With Necrotizing Enterocolitis	From enrollment until 36 weeks postmenstrual age, discharge or death		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Infants With Septicemia	From enrollment until 36 weeks postmenstrual age, discharge or death		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Infants With Severe Intraventricular Hemorrhage	From enrollment until 36 weeks postmenstrual age, discharge or death		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

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

Outcome	Group	Value	Spread	Units
Age at First Successful Extubation	Caffeine Arm	24	Inter-Quartile Range 9.5 to 41	days
Age at First Successful Extubation	Placebo Arm	20	Inter-Quartile Range 9.3 to 43	days
Survival	Caffeine Arm	32		Participants
Survival	Placebo Arm	37		Participants
Total Duration of Mechanical Ventilation	Caffeine Arm	32	Inter-Quartile Range 11 to 43	days
Total Duration of Mechanical Ventilation	Placebo Arm	26	Inter-Quartile Range 10 to 44	days
Total Duration of Oxygen Supplementation	Caffeine Arm	55	Inter-Quartile Range 31 to 86	days
Total Duration of Oxygen Supplementation	Placebo Arm	59	Inter-Quartile Range 36 to 106	days
Number of Infants With Bronchopulmonary Dysplasia (BPD)	Caffeine Arm	15		Participants
Number of Infants With Bronchopulmonary Dysplasia (BPD)	Placebo Arm	20		Participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Caffeine Arm	42
Overall Study	STARTED	Placebo Arm	44
Overall Study	COMPLETED	Caffeine Arm	41
Overall Study	COMPLETED	Placebo Arm	42
Overall Study	NOT COMPLETED	Caffeine Arm	1
Overall Study	NOT COMPLETED	Placebo Arm	2

Source ClinicalTrials.gov

Adverse events4

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

Type	Event	Organ system	Group	At risk
serious	Seizures	Nervous system disorders	Caffeine Arm	41
serious	Seizures	Nervous system disorders	Placebo Arm	42
serious	Tachycardia	Cardiac disorders	Caffeine Arm	41
serious	Tachycardia	Cardiac disorders	Placebo Arm	42

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Caffeine Arm	9	41
Total, all-cause mortality	Placebo Arm	5	42
Total, other adverse events	Caffeine Arm	0	41
Total, other adverse events	Placebo Arm	0	41
Total, serious adverse events	Caffeine Arm	0	41
Total, serious adverse events	Placebo Arm	0	42

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29519541	DERIVED

Source PubMed

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 comparisons10

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

Comparison	Source
Caffeine Arm vs Placebo Arm: Number of Infants With Severe Retinopathy of Prematurity	Trial comparisons
Caffeine Arm vs Placebo Arm: Number of Infants With Bronchopulmonary Dysplasia (BPD)	Trial comparisons
Caffeine Arm vs Placebo Arm: Number of Infants With Septicemia	Trial comparisons
Caffeine Arm vs Placebo Arm: Number of Infants With Pulmonary Hemorrhage	Trial comparisons
Caffeine Arm vs Placebo Arm: Number of Infants With Severe Intraventricular Hemorrhage	Trial comparisons
Caffeine Arm vs Placebo Arm: Survival	Trial comparisons
Caffeine Arm vs Placebo Arm: Survival Without BPD	Trial comparisons
Caffeine Arm vs Placebo Arm: Number of Infants With Necrotizing Enterocolitis	Trial comparisons
Caffeine Arm vs Placebo Arm: deaths from any cause	Trial comparisons
Caffeine Arm vs Placebo Arm: 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.

GET https://conductscience.org/api/trials/v1/NCT01751724

GET https://conductscience.org/api/trials/v1/NCT01751724/results?page=2

API reference For AI assistants