A Phase 4 interventional study of Sezaby in Neonatal Seizure, sponsored by Sun Pharma Advanced Research Company Limited. Not yet recruiting at 1 site in United States. Open to participants aged 0 Days to 27 Days. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Sun Pharma Advanced Research Company Limited (formerly part of Sun Pharmaceutical Industries Limited) · Phase 4, Interventional, and Other
This Phase 4, multicenter, single-arm, open-label study evaluates the effect of intravenous Sezaby (phenobarbital sodium) on electrocardiographic safety, including the QT interval, in neonates with seizures.
This Phase 4, multicenter, single-arm, open-label study evaluates the effect of Sezaby on electrocardiographic safety, including the QT interval, in neonates with seizures. Participants will receive intravenous Sezaby and undergo electrocardiographic and safety assessments during treatment.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's planned enrollment of 45 is below the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →Sun Pharma Advanced Research Company Limited is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 4 (31%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neonates with seizures receiving intravenous Sezaby administered as loading dose(s) followed by maintenance dosing for up to 5 days according to the study protocol.
Drug: Sezaby
Sezaby (phenobarbital sodium for injection) is administered as intravenous loading and maintenance doses over a treatment period of up to 5 days for the treatment of neonatal seizures.
Also known as: Phenobarbital sodium
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Change from baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) following treatment with Sezaby. QTcF values will be assessed from electrocardiogram recordings obtained during the treatment period.
Time frame: Baseline through Day 5
Change From Baseline in QT Interval Corrected Using Bazett's Formula (QTcB)
Change from baseline in QT interval corrected for heart rate using Bazett's formula (QTcB) following treatment with Sezaby.
Time frame: Baseline through Day 5
Incidence of Treatment-Emergent Adverse Events
Assessment of safety based on the incidence of treatment-emergent adverse events (TEAEs) following administration of Sezaby.
Time frame: First dose through Safety Follow-up (approximately 20 days)
Change From Baseline in QTcF and QTcB Intervals in Participants With Hypoxic-Ischemic Encephalopathy (HIE) Compared With Participants Without HIE
Change from baseline in QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) in participants with HIE compared with participants without HIE following treatment with Sezaby.
Time frame: Baseline through Day 5
Frequency of Treatment-Emergent Changes in Electrocardiogram Morphology
Frequency of treatment-emergent changes in electrocardiogram (ECG) morphology following treatment with Sezaby.
Time frame: Baseline through Day 5
Incidence of Categorical Outliers in QTcF, QTcB, Heart Rate, PR Interval, and QRS Interval
Incidence of categorical outliers in QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), heart rate (HR), PR interval, and QRS interval following treatment with Sezaby.
Time frame: Baseline through Day 5
Plasma Concentration of Phenobarbital
Assessment of plasma concentrations of phenobarbital following administration of Sezaby.
Time frame: Baseline through Day 5
A. Correlation Between Post-Conceptional Age and Change From Baseline in QTcF
Correlation between post-conceptional age, measured in completed weeks, and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.
Time frame: Baseline through Day 5
B. Correlation Between Post-Conceptional Age and Change From Baseline in QTcB
Correlation between post-conceptional age, measured in completed weeks, and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.
Time frame: Baseline through Day 5
A. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcF
Correlation between daily serum sodium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately for each protocol-specified ECG assessment time point.
Time frame: Baseline through Day 5
B. Correlation Between Serum Sodium Concentration and Change From Baseline in QTcB
Correlation between daily serum sodium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately for each protocol-specified ECG assessment time point.
Time frame: Baseline through Day 5
C. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcF
Correlation between daily serum potassium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately for each protocol-specified ECG assessment time point.
Time frame: Baseline through Day 5
D. Correlation Between Serum Potassium Concentration and Change From Baseline in QTcB
Correlation between daily serum potassium concentration, measured by the clinical laboratory (mmol/L), and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings.
Time frame: Baseline through Day 5
E. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcF
Correlation between daily serum calcium concentration, measured by the clinical laboratory (mg/dL or mmol/L per protocol laboratory reporting), and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings.
Time frame: Baseline through Day 5
F. Correlation Between Serum Calcium Concentration and Change From Baseline in QTcB
Correlation between daily serum calcium concentration, measured by the clinical laboratory (mg/dL or mmol/L per protocol laboratory reporting), and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings.
Time frame: Baseline through Day 5
A. Correlation Between Body Temperature and Change From Baseline in QTcF
Correlation between body temperature, measured in degrees Celsius at or near each protocol-specified ECG assessment, and change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.
Time frame: Baseline through Day 5
B. Correlation Between Body Temperature and Change From Baseline in QTcB
A correlation coCorrelation between body temperature, measured in degrees Celsius at or near each protocol-specified ECG assessment, and change from baseline in the QT interval corrected using Bazett's formula (QTcB), measured in milliseconds from centrally evaluated continuous 12-lead electrocardiogram recordings. A correlation coefficient will be calculated across participants separately at each protocol-specified ECG assessment time point.efficient will be calculated across participants separately at each protocol-specified ECG assessment time point.
Time frame: Baseline through Day 5
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Phenobarbital
Sun Pharma Advanced Research Company Limited →