Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

2014-08-27 03:57:10 | BioPortfolio


This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.


The administration of phenobarbital to pregnant women before delivery has been thought to decrease the frequency of intracranial hemorrhage in preterm infants. To evaluate this potential neuroprotective therapy further, we determined the effect of antenatal administration of phenobarbital on the frequency of neonatal intracranial hemorrhage and early death. Women who were 24 to 33 weeks pregnant and who were expected to deliver their infants within 24 hours were randomly assigned to receive either intravenous phenobarbital (10 mg/kg body weight) or placebo, followed by maintenance doses until delivery or 34 wks gestation. Infants less than 34 wks at birth underwent serial cranial ultrasonography to detect the presence of intracranial hemorrhage. The sample size of 1038 pregnancies was based on an intracranial hemorrhage rate of 20 percent in the placebo and less than 12 percent in the phenobarbital group; 90 percent power; a 5 percent two-tailed type 1 error; and an 8 percent noncompliance rate. The twin with the highest grade of intracranial hemorrhage was included.

Degree of maternal sedation was evaluated after administration of study drug. Neonatal ultrasound exams were performed at 3-5 days, 10-14 days, and 38-42 wks postmenstrual age; neonatal medications were recorded during the first week of life; treatments, and outcomes were recorded through death, discharge, or 120 days, whichever occurred first. Neurodevelopmental outcome was evaluated at 18-22 months corrected age by certified examiners masked to treatment status.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intracranial Hemorrhage






Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:57:10-0400

Clinical Trials [576 Associated Clinical Trials listed on BioPortfolio]

Intravenous Immunoglobulin for Acute Intracranial Hemorrhage

This pilot study aims to investigate whether intravenous immunoglobulin is safe and effective in alleviating perihematomal edema and neurologic deficits in patients with intracranial hemor...

FFP Versus PCC in Traumatic Intracranial Hemorrhage

The goal of this study will be to determine whether PCC confers any benefits over FFP in the traumatic intracranial hemorrhage with respect to multiple factors including time to correction...

Study of Phenobarbital Inhibition of Catamenial Epilepsy

The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy. We propose that since the catamenial seizures are associated with...

Prophylactic Phenobarbital After Neonatal Seizures

The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful o...

Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?

The purpose of this study is to explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with su...

PubMed Articles [1376 Associated PubMed Articles listed on BioPortfolio]

The Impact of Infection and Elevated INR in LVAD-Associated Intracranial Hemorrhage: A Case-Crossover Study.

Despite the common occurrence left ventricular assist device (LVAD)-associated intracranial hemorrhage, the etiology of intracranial hemorrhage is uncertain. We aim to explore the impact of infection ...

Intratumoral Hemorrhage within a Petrous Meningioma.

Intracranial hemorrhage stemming from a benign intracranial lesion is much less commonly seen than from malignant tumors such as gliomas or metastases. Cerebellopontine angle (CPA) lesions rarely pres...

Intracranial hemorrhage after superficial temporal artery-middle cerebral artery direct anastomosis for adults with moyamoya disease.

Intracranial hemorrhage, such as intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH) and intraventricular hemorrhage (IVH) is an extremely rare complication after surgical revascularization ...

Symptomatic periprocedural intracranial hemorrhage unrelated to coil embolization in 1287 patients with intracranial aneurysms.

Periprocedural symptomatic intracranial hemorrhage (sICH) unrelated to coil embolization of intracranial aneurysm has been rarely reported. The incidence and characteristics of this complication remai...

Intracranial Hemorrhage in Children With Inherited Bleeding Disorders: A Single Center Study in China.

Intracranial hemorrhage (ICH) is a life-threatening condition in children. Inherited bleeding disorders (IBD) have high risk of ICH.

Medical and Biotech [MESH] Definitions

Bleeding into the intracranial or spinal SUBARACHNOID SPACE, most resulting from INTRACRANIAL ANEURYSM rupture. It can occur after traumatic injuries (SUBARACHNOID HEMORRHAGE, TRAUMATIC). Clinical features include HEADACHE; NAUSEA; VOMITING, nuchal rigidity, variable neurological deficits and reduced mental status.

Abnormal outpouching in the wall of intracranial blood vessels. Most common are the saccular (berry) aneurysms located at branch points in CIRCLE OF WILLIS at the base of the brain. Vessel rupture results in SUBARACHNOID HEMORRHAGE or INTRACRANIAL HEMORRHAGES. Giant aneurysms (>2.5 cm in diameter) may compress adjacent structures, including the OCULOMOTOR NERVE. (From Adams et al., Principles of Neurology, 6th ed, p841)

Bleeding into the SUBARACHNOID SPACE due to CRANIOCEREBRAL TRAUMA. Minor hemorrhages may be asymptomatic; moderate to severe hemorrhages may be associated with INTRACRANIAL HYPERTENSION and VASOSPASM, INTRACRANIAL.

Intracranial bleeding into the PUTAMEN, a BASAL GANGLIA nucleus. This is associated with HYPERTENSION and lipohyalinosis of small blood vessels in the putamen. Clinical manifestations vary with the size of hemorrhage, but include HEMIPARESIS; HEADACHE; and alterations of consciousness.

Bleeding within the SKULL that is caused by systemic HYPERTENSION, usually in association with INTRACRANIAL ARTERIOSCLEROSIS. Hypertensive hemorrhages are most frequent in the BASAL GANGLIA; CEREBELLUM; PONS; and THALAMUS; but may also involve the CEREBRAL CORTEX, subcortical white matter, and other brain structures.

More From BioPortfolio on "Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage"

Quick Search


Relevant Topics

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial