Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage (PhysDis)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Baylor University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Radin Kaiser, MD, MA, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00665769
First received: April 22, 2008
Last updated: January 29, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]
  • The effect of hypercapnia vs. normocapnia on abnormal results from MRIs [ Time Frame: at term-equivalent age ] [ Designated as safety issue: Yes ]
  • The effect of hypercapnia vs. normocapnia on the development of pulmonary hemorrhage [ Time Frame: During the initial hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 164
Study Start Date: June 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665769

Contacts
Contact: Jeffrey R. Kaiser, MD, MA 832-826-3702 jrkaiser@texaschildrens.org
Contact: Donna J Hall, RN 832-826-7702 djhall@texaschildrens.org

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jeffrey R Kaiser, MD, MA    832-826-3702    jrkaiser@texaschildrens.org   
Contact: Donna J Hall, RN    832-826-7702    djhall@texaschildrens.org   
Principal Investigator: Jeffrey R Kaiser, MD, MA         
Sponsors and Collaborators
Baylor University
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 College of Medicine
ClinicalTrials.gov Identifier: NCT00665769     History of Changes
Other Study ID Numbers: H-31475, 1RO1NS60674-01A1
Study First Received: April 22, 2008
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Texas Children's Hospital Clinical Research Center Data Safety and Monitoring Board

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

ClinicalTrials.gov processed this record on October 20, 2014