Phase 4
N=74
MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
Apnea of Prematurity · Intraventricular Hemorrhage · Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00809055 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: White Matter Microstructural Maturation — 1.43; 1.42 apparent diffusion coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Caffeine citrate (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY White Matter Microstructural Maturation |
1.43; 1.42 | — |
| SECONDARY Mortality Rates |
7; 5 | — |
| SECONDARY Cerebellar Hemorrhage |
10; 3 | — |
| SECONDARY Length of Time Requiring Invasive Respiratory Support |
4; 3 | — |
| SECONDARY Rates of Chronic Lung Disease |
19; 18 | — |
| SECONDARY Rates of Necrotizing Enterocolitis |
6; 5 | — |
| SECONDARY Rates of Retinopathy of Prematurity |
2; 4 | — |
| SECONDARY Evaluation of EEG Seizure Burden |
48.9; 170.9 | — |
| SECONDARY Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge |
17.4; 18.7 | — |
| SECONDARY Bayley Scales of Infant Development Cognitive Score at 2 Years of Age |
85.6; 88.0 | — |
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 movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities.
We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00809055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.