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Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage

Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00665769
Acronym
PhysDis
Enrollment
103
Registered
2008-04-24
Start date
2008-06-30
Completion date
2015-11-30
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoregulation, Intraventricular Hemorrhage

Keywords

hypercapnia, normocapnia, chronic lung disease, periventricular leukomalacia, intraventricular hemorrhage, hypotension, cerebral autoregulation, heart rate variability, autonomic nervous system, detrended fluctuation analysis

Brief summary

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.

Interventions

OTHERHypercapnia

transcutaenous CO2 50-60 mm Hg

transcutaneous CO2 35-45 mm Hg

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 7 Days
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

Design outcomes

Primary

MeasureTime frame
The effect of hypercapnia vs. normocapnia on the development of Grade II-IV intraventricular hemorrhage/periventricular leukomalacia (severe brain injury) and/or deathDuring first 2 weeks of life (intraventricular hemorrhage and/or death), initial hospitalization for periventricular leukomalacia

Secondary

MeasureTime frame
The effect of hypercapnia vs. normocapnia on the development of chronic lung disease (requirement of supplemental oxygen at 36 weeks corrected gestational age)By 36 weeks corrected gestational age.
The effect of hypercapnia vs. normocapnia on abnormal results from MRIsat term-equivalent age
The effect of hypercapnia vs. normocapnia on the development of pulmonary hemorrhageDuring the initial hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026