Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage (PhysDis)
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ClinicalTrials.gov Identifier: NCT00665769 |
Recruitment Status
:
Terminated
(Recruitment was proceeding too slowly)
First Posted
: April 24, 2008
Last Update Posted
: February 7, 2017
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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.
- 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.
- 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.
- 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 or disease | Intervention/treatment | Phase |
---|---|---|
Intraventricular Hemorrhage Autoregulation | Other: Hypercapnia Other: Normocapnia | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | November 2015 |
Estimated Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
---|---|
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.
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Other: Hypercapnia
transcutaenous CO2 50-60 mm Hg
Other Names:
|
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.
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Other: Normocapnia
transcutaneous CO2 35-45 mm Hg
Other Name: Normocarbia
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- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665769
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jeffrey R. Kaiser, MD, MA | Baylor College of Medicine |
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 ( U.S. NIH Grant/Contract ) |
First Posted: | April 24, 2008 Key Record Dates |
Last Update Posted: | February 7, 2017 |
Last Verified: | February 2017 |
Keywords provided by Jeffrey Radin Kaiser, MD, MA, 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 |