Status:
COMPLETED
MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Apnea of Prematurity
Intraventricular Hemorrhage
Eligibility:
All Genders
24-30 years
Phase:
PHASE4
Brief Summary
Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and mo...
Detailed Description
Apnea is defined as a cessation of breathing for twenty seconds or greater, or as a brief episode if associated with bradycardia, cyanosis, or pallor. Recurrent apnea of prematurity occurs in up to 85...
Eligibility Criteria
Inclusion
- Preterm infants from 24 to 30 weeks completed PMA admitted to the neonatal intensive care unit (NICU) at St. Louis Children's Hospital. The estimated post menstrual age will be provided by the obstetrical records and compared with a Dubowitz exam at admission. The provided PMA will be used unless the Dubowitz exam has a discrepancy of greater or equal to 2 weeks, where then the Dubowitz age will be used.
- Infants must be recruited within the first 24 hours of life.
Exclusion
- Infants over 30 weeks gestation.
- Infants who are moribund with severe sepsis, in respiratory failure, or have severe brain injury present in the first 24 hours of life. This would be defined as physiologic instability requiring \>80% FiO2 for 6 hours and/or more than 2 inotropic drugs (excluding hydrocortisone), or in the attending or recruiting physicians' opinion the infant is likely to die within 24 hours or would not tolerate any handling for the protocol.
- Infants must not have received any doses of caffeine citrate prior to enrollment.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00809055
Start Date
November 1 2008
End Date
December 1 2015
Last Update
February 24 2016
Active Locations (1)
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1
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110