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Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

Information source: NICHD Neonatal Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Intracranial Hemorrhages

Intervention: Phenobarbital (Drug); Saline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NICHD Neonatal Research Network

Official(s) and/or principal investigator(s):
Seetha Shankaran, MD, Study Director, Affiliation: Wayne State University
Lu-Ann Papile, MD, Principal Investigator, Affiliation: University of New Mexico
Richard A. Ehrenkranz, MD, Principal Investigator, Affiliation: Yale University
Raymond Bain, PhD, Principal Investigator, Affiliation: George Washington University
James A. Lemons, MD, Principal Investigator, Affiliation: Indiana University
Sheldon B. Korones, MD, Principal Investigator, Affiliation: University of Tennessee at Memphis
David K. Stevenson, MD, Principal Investigator, Affiliation: Stanford University
Edward F. Donovan, MD, Principal Investigator, Affiliation: Cincinnati Children's Medical Center
Barbara J. Stoll, MD, Principal Investigator, Affiliation: Emory University
Avroy A. Fanaroff, MD, Principal Investigator, Affiliation: Case Western Reserve University
William Oh, MD, Principal Investigator, Affiliation: Brown University, Women and Infants Hospital

Summary

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.

Clinical Details

Official title: Randomized Clinical Trial of Antenatal Phenobarbital in the Prevention of Neonatal Intracranial Hemorrhage

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: Neonatal intracranial hemorrhage or death

Secondary outcome:

Intracranial hemorrhage (grade I, II, III, or IV)

Periventricular leukomalacia

Neurodevelopmental impairment

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Admission to a high risk perinatal unit or labor and delivery unit;

- 24 to 32 completed weeks gestation;

- Expected delivery within 24 hrs;

- Preterm labor or no labor with planned delivery for maternal-fetal indications;

Exclusion Criteria:

- Anticipated delivery within two hours

- Multiple congenital or chromosomal abnormalities in the fetus

- Multiple gestation with more than two fetuses

- Administration of phenobarbital during the pregnancy

- Administration of indomethacin within one week before admission

- Maternal platelet count of less than 100,000 per cubic millimeter

Locations and Contacts

Stanford University, Palo Alto, California 94304, United States

Yale University, New Haven, Connecticut 06504, United States

George Washington University, Washington, District of Columbia 20052, United States

Emory University, Atlanta, Georgia 30303, United States

Indiana University, Indianapolis, Indiana 46202, United States

Wayne State University, Detroit, Michigan 48201, United States

University of New Mexico, Albuquerque, New Mexico 87131, United States

Cincinnati Children's Medical Center, Cincinnati, Ohio 45267, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States

Brown University, Women & Infants Hospital of Rhode Island, Providence, Rhode Island 02905, United States

University of Tennessee, Memphis, Tennessee 38163, United States

Additional Information

NICHD Neonatal Research Network

Starting date: February 1993
Last updated: June 3, 2015

Page last updated: August 23, 2015

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