Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-02-28

Study Completion Date

1997-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Intracranial Hemorrhages

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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Phenobarbital

Group Type EXPERIMENTAL

Phenobarbital

Intervention Type DRUG

10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)

Placebo

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Infusion of normal sal

Interventions

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Phenobarbital

10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)

Intervention Type DRUG

Saline

Infusion of normal sal

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Wayne State University

Principal Investigators

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Seetha Shankaran, MD

Role: STUDY_DIRECTOR

Wayne State University

Lu-Ann Papile, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Raymond Bain, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

James A. Lemons, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Sheldon B. Korones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee at Memphis

David K. Stevenson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Edward F. Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Avroy A. Fanaroff, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

William Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women and Infants Hospital

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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Shankaran S, Papile LA, Wright LL, Ehrenkranz RA, Mele L, Lemons JA, Korones SB, Stevenson DK, Donovan EF, Stoll BJ, Fanaroff AA, Oh W. The effect of antenatal phenobarbital therapy on neonatal intracranial hemorrhage in preterm infants. N Engl J Med. 1997 Aug 14;337(7):466-71. doi: 10.1056/NEJM199708143370705.

Reference Type RESULT

PMID: 9250849 (View on PubMed)

McCain GC, Donovan EF, Gartside P. Preterm infant behavioral and heart rate responses to antenatal phenobarbital. Res Nurs Health. 1999 Dec;22(6):461-70. doi: 10.1002/(sici)1098-240x(199912)22:63.0.co;2-t.

Reference Type RESULT

PMID: 10625862 (View on PubMed)

Shankaran S, Papile LA, Wright LL, Ehrenkranz RA, Mele L, Lemons JA, Korones SB, Stevenson DK, Donovan EF, Stoll BJ, Fanaroff AA, Oh W, Verter J. Neurodevelopmental outcome of premature infants after antenatal phenobarbital exposure. Am J Obstet Gynecol. 2002 Jul;187(1):171-7. doi: 10.1067/mob.2002.122445.

Reference Type RESULT

PMID: 12114906 (View on PubMed)