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Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage (PhysDis)

This study has been terminated.
(Recruitment was proceeding too slowly)
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jeffrey Radin Kaiser, MD, MA, Baylor University
ClinicalTrials.gov Identifier:
NCT00665769
First received: April 22, 2008
Last updated: February 3, 2017
Last verified: February 2017
  Purpose

Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is associated with many problems, including mental retardation, cerebral palsy, and learning disabilities, that result in profound individual and familial consequences. In addition, lifetime care costs for these severely affected infants born in a single year exceed $3 billion. The huge individual and societal costs underscore the need for developing care strategies that may limit severe bleeding in the brain of these tiny infants. The overall goal of our research is to evaluate disturbances of brain blood flow in these tiny infants in order to predict which of them are at highest risk and to develop better intensive care techniques that will limit severe brain injury.

  1. Since most of these infants require ventilators (respirators) to survive, we will investigate how 2 different methods of ventilation affect brain injury. We believe that a new method of ventilation, allowing normal carbon dioxide levels, will normalize brain blood flow and lead to less bleeding in the brain.
  2. We will also examine how treatment for low blood pressure in these infants may be associated with brain injury. We believe that most very premature infants with low blood pressure actually do worse if they are treated. We think that by allowing the infants to normalize blood pressure on their own will allow them to stabilize blood flow to the brain leading to less intraventricular hemorrhage.
  3. In 10 premature infants with severe brain bleeding, we have developed a simple technique to identify intraventricular hemorrhage before it happens. Apparently, the heart rate of infants who eventually develop severe intraventricular hemorrhage is less variable than infants who do not develop this. We plan to test this method in a large group of infants, to be able to predict which infants are at highest risk of developing intraventricular hemorrhage and who could most benefit from interventions that would reduce disturbances of brain blood flow.

Condition Intervention
Intraventricular Hemorrhage
Autoregulation
Other: Hypercapnia
Other: Normocapnia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage

Resource links provided by NLM:


Further study details as provided by Baylor University:

Primary Outcome Measures:
  • The effect of hypercapnia vs. normocapnia on the development of Grade II-IV intraventricular hemorrhage/periventricular leukomalacia (severe brain injury) and/or death [ Time Frame: During first 2 weeks of life (intraventricular hemorrhage and/or death), initial hospitalization for periventricular leukomalacia ]

Secondary Outcome Measures:
  • The effect of hypercapnia vs. normocapnia on the development of chronic lung disease (requirement of supplemental oxygen at 36 weeks corrected gestational age) [ Time Frame: By 36 weeks corrected gestational age. ]
  • The effect of hypercapnia vs. normocapnia on abnormal results from MRIs [ Time Frame: at term-equivalent age ]
  • The effect of hypercapnia vs. normocapnia on the development of pulmonary hemorrhage [ Time Frame: During the initial hospitalization ]

Enrollment: 103
Study Start Date: June 2008
Estimated Study Completion Date: September 2017
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Hypercapnia
Hypercapnic ventilation. The goal will be to maintain transcutaneous CO2 55 mm Hg (50-60 mm Hg) during the first week of life, or until extubation. A written, laminated hypercapnic ventilator algorithm will be placed at the bedside.
Other: Hypercapnia
transcutaenous CO2 50-60 mm Hg
Other Names:
  • hypercarbia
  • permissive hypercapnia
Active Comparator: Normocapnia
Normocapnic ventilation. The goal will be to maintain transcutaenous CO2 40 mm Hg (35-45 mm Hg) during the first week of life, or until extubation. A written, laminated normocapnic ventilator algorithm will be placed at the bedside.
Other: Normocapnia
transcutaneous CO2 35-45 mm Hg
Other Name: Normocarbia

  Eligibility

Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ventilated ELBW (401-1000 grams) infants
  • 23 to 30 weeks' gestation
  • umbilical arterial catheter placed during newborn resuscitation

Exclusion Criteria:

  • presence of complex congenital anomalies or chromosomal abnormality
  • presence of central nervous system malformation
  • infants with hydrops fetalis
  • infants in extremis
  • infants with early (<3 hour of age) intraventricular hemorrhage
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00665769

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Jeffrey R. Kaiser, MD, MA Baylor College of Medicine
  More Information

Publications:

Responsible Party: Jeffrey Radin Kaiser, MD, MA, Professor of Pediatrics and Obstetrics and Gynecology, Baylor University
ClinicalTrials.gov Identifier: NCT00665769     History of Changes
Other Study ID Numbers: H-31475
1R01NS060674 ( US NIH Grant/Contract Award Number )
Study First Received: April 22, 2008
Last Updated: February 3, 2017

Keywords provided by Baylor University:
hypercapnia
normocapnia
chronic lung disease
periventricular leukomalacia
intraventricular hemorrhage
hypotension
cerebral autoregulation
heart rate variability
autonomic nervous system
detrended fluctuation analysis

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Fetal Diseases
Infant, Newborn, Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on April 21, 2017