Trial · NCT01089504

Prophylactic Phenobarbital After Neonatal Seizures

NCT01089504, Phase 4, Terminated, University of Rochester; results first posted 2016-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prophylactic Phenobarbital After Neonatal Seizures. Trials, record NCT01089504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01089504

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Trial

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

Title: Prophylactic Phenobarbital After Neonatal Seizures
NCT number: NCT01089504
Status: Terminated
Phases: Phase 4
Enrollment: 13 participants, actual
Lead sponsor: University of Rochester
Conditions: Neonatal Seizures
Interventions: phenobarbital, placebo
First posted: 2010-03-18
Last updated: 2016-02-03
Results first posted: 2016-02-03
Limitations and caveats: Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary analysis.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Mean Bayley Scales of Infant Development (BSID) Score - Cognitive	18-22 months	The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) - very similar to the more familiar IQ score.
Secondary	Mean Bayley Scales of Infant Development (BSID) Score - Motor	18-22 months	This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch.
Secondary	Number of Participants With One or More Seizures	18-22 months	Any clinical or electrographic seizures occurring between study entry and all follow-up examinations and contacts.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Bayley Scales of Infant Development (BSID) Score - Cognitive	18-22 months	Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.	units on a scale	MEAN
SECONDARY	Mean Bayley Scales of Infant Development (BSID) Score - Motor	18-22 months	Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.	units on a scale	MEAN
SECONDARY	Number of Participants With One or More Seizures	18-22 months	Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Mean Bayley Scales of Infant Development (BSID) Score - Cognitive	Phenobarbital	87.50	Standard Deviation 11.90	units on a scale
Mean Bayley Scales of Infant Development (BSID) Score - Cognitive	Placebo	92.50	Standard Deviation 26.61	units on a scale
Mean Bayley Scales of Infant Development (BSID) Score - Motor	Phenobarbital	82.80	Standard Deviation 24.59	units on a scale
Mean Bayley Scales of Infant Development (BSID) Score - Motor	Placebo	83.75	Standard Deviation 20.65	units on a scale
Number of Participants With One or More Seizures	Phenobarbital	2		participants
Number of Participants With One or More Seizures	Placebo	1		participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phenobarbital	8
Overall Study	STARTED	Placebo	5
Overall Study	COMPLETED	Phenobarbital	5
Overall Study	COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Phenobarbital	3
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events46

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	apnoea	Respiratory, thoracic and mediastinal disorders	Phenobarbital	0	8
other	apnoea	Respiratory, thoracic and mediastinal disorders	Placebo	1	5
other	convulsion	Nervous system disorders	Phenobarbital	1	8
other	convulsion	Nervous system disorders	Placebo	1	5
other	Pyrexia	General disorders	Phenobarbital	3	8
other	Pyrexia	General disorders	Placebo	1	5
other	upper respiratory tract infection	Infections and infestations	Phenobarbital	0	8
other	upper respiratory tract infection	Infections and infestations	Placebo	1	5
other	Haematochezia	Gastrointestinal disorders	Phenobarbital	0	8
other	Haematochezia	Gastrointestinal disorders	Placebo	1	5

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phenobarbital
Total, all-cause mortality	Placebo
Total, other adverse events	Phenobarbital	6	8
Total, other adverse events	Placebo	5	5
Total, serious adverse events	Phenobarbital	1	8
Total, serious adverse events	Placebo	1	5

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 comparisons2

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

Comparison	Source
Phenobarbital vs Placebo: Number of Participants With One or More Seizures	Trial comparisons
Phenobarbital vs Placebo: 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/NCT01089504

GET https://conductscience.org/api/trials/v1/NCT01089504/events?page=2

API reference For AI assistants