Clinical Trial: Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage

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
   

   Detailed Summary:
   Sponsor: Baylor University
   

   Current Primary Outcome: 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 ]
   
   

   Original Primary Outcome:

   • The effect of hypercapnia vs. normocapnia on the development of intraventricular hemorrhage during the first week of life [ Time Frame: During first week of life ]
   • The effect of hypercapnia and hypotension on the capacity for cerebral autoregulation [ Time Frame: First week of life ]
   • The development of intraventricular hemorrhage based upon abnormal heart rate variability [ Time Frame: first week of life ]
   
   
   

   Current Secondary Outcome:

   • 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 ]
   
   
   

   Original Secondary Outcome:

   • The effect of hypercapnia vs. normocapnia on the development of chronic lung disease during premature infants' initial hospitalization [ Time Frame: By 36 weeks corrected gestational age. ]
   • The effect of hypercapnia vs. normocapnia on the development of respiratory complications (number of days on mechanical ventilation, air leaks, number of reintubations) [ Time Frame: During the initial newborn hospitalization ]
   • The effect of hypercapnia vs. normocapnia survival and length of hospital stay. [ Time Frame: During the initial newborn hospitalization ]
   • The effect of hypercapnia vs. normocapnia on the development of periventricular leukomalacia [ Time Frame: During the initial hospitalizaiton ]
   
   
   Information By: Baylor University
   

   Dates:
   Date Received: April 22, 2008
   Date Started: June 2008
   Date Completion: September 2017
   Last Updated: February 3, 2017
   Last Verified: February 2017