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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021373 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD027851 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| U10HD027904 | U.S. NIH Grant/Contract | View source | |
| U10HD040492 | U.S. NIH Grant/Contract | View source | |
| U10HD040689 | U.S. NIH Grant/Contract | View source | |
| UL1RR025744 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites.
Few techniques exist to permit early and accurate prognosis of brain injury in newborns. Cranial ultrasound and magnetic resonance imaging (MRI) have been used to detect structural abnormalities which may be useful in predicting neuromotor and neurocognitive deficits. However, up to 30% of extremely low birth weight infants with normal ultrasounds have adverse outcomes, and MRI is not feasible when an infant is critically ill. Amplitude-integrated electroencephalogram (aEEG) is a non-invasive, bedside instrument which allows real-time monitoring of brain function and may provide additional information for predicting outcomes in extremely premature infants.
This observational study will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites. Eligible infants will undergo an aEEG recording in the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age.
The study tests the feasibility of enrolling subjects and obtaining the required aEEG recordings. The information gathered will provide a framework for the design of a potential prospective, observational, multi-center study for prediction of death or neurodevelopmental impairment by 18-22 months of age.
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| Measure | Description | Time Frame |
|---|---|---|
| First aEEG within 72 hours of age | < 72 hours of age |
| Measure | Description | Time Frame |
|---|---|---|
| Time required by research personnel to conduct study activities | Birth to 36 weeks post menstrual age | |
| Serious adverse events | < 72 hours of age until 36 weeks post menstrual age | |
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Inclusion Criteria:
Exclusion Criteria:
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Infants born at NRN centers and admitted to the NICU that are between 401 grams and 1,000 grams OR between 23 0/7 and 28 6/7 weeks gestational age. Infants must be enrolled by the time they are 72 hours old.
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| Name | Affiliation | Role |
|---|---|---|
| Abbot R. Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | Principal Investigator |
| Ricki F. Goldstein, MD | Duke University | Principal Investigator |
| Barbara J. Stoll, MD | Emory University | Principal Investigator |
| Abhik Das, PhD | RTI International | Principal Investigator |
| Alexis Davis, MD | Stanford University | Principal Investigator |
| Lina Chalak, MD | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Kathleen A. Kennedy, MD MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25474559 | Result | Davis AS, Gantz MG, Do B, Shankaran S, Hamrick SE, Kennedy KA, Tyson JE, Chalak LF, Laptook AR, Goldstein RF, Hintz SR, Das A, Higgins RD, Ball MB, Hale EC, Van Meurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serial aEEG recordings in a cohort of extremely preterm infants: feasibility and safety. J Perinatol. 2015 May;35(5):373-8. doi: 10.1038/jp.2014.217. Epub 2014 Dec 4. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Agreement between aEEG recordings and clinical events including: seizures, cardiopulmonary resuscitation, surfactant administration, suctioning, and intubation |
| < 72 hours of age until 36 weeks post menstrual age |
| Weekly aEEG until infant is 36 weeks post menstrual age | < 72 hours of age until 36 weeks post menstrual age |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| RTI International | Durham | North Carolina | 27705 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| D000091642 | Urogenital Diseases |