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Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage (Phenobarbital)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00009620
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network

Tracking Information
First Submitted Date  ICMJE February 1, 2001
First Posted Date  ICMJE February 5, 2001
Last Update Posted Date March 22, 2019
Study Start Date  ICMJE February 1993
Actual Primary Completion Date February 1995   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2011)
Neonatal intracranial hemorrhage or death [ Time Frame: 72 hours of life ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2011)
  • Intracranial hemorrhage (grade I, II, III, or IV) [ Time Frame: 72 hours of life ]
  • Periventricular leukomalacia [ Time Frame: 72 hours of life ]
  • Neurodevelopmental impairment [ Time Frame: 18 to 22 months of corrected age ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
Official Title  ICMJE Randomized Clinical Trial of Antenatal Phenobarbital in the Prevention of Neonatal Intracranial Hemorrhage
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Intracranial Hemorrhages
Intervention  ICMJE
  • Drug: Phenobarbital
    10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)
  • Drug: Saline
    Infusion of normal sal
Study Arms  ICMJE
  • Experimental: Phenobarbital
    Intervention: Drug: Phenobarbital
  • Placebo Comparator: Placebo
    Intervention: Drug: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2011)
610
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
1038
Actual Study Completion Date  ICMJE February 1997
Actual Primary Completion Date February 1995   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00009620
Other Study ID Numbers  ICMJE NICHD-NRN-0006
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U01HD019897 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seetha Shankaran/ Lead Principal Investigator, Wayne State University
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Study Director: Seetha Shankaran, MD Wayne State University
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Raymond Bain, PhD George Washington University
Principal Investigator: James A. Lemons, MD Indiana University
Principal Investigator: Sheldon B. Korones, MD University of Tennessee at Memphis
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University
Principal Investigator: William Oh, MD Brown University, Women and Infants Hospital
PRS Account NICHD Neonatal Research Network
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP