N/A
Completed N=63
Prospective Research in Infants With Mild Encephalopathy
hypoxic-ischemic encephalopathy · Brain Injury · Neonatal Seizure
Source: ClinicalTrials.gov NCT01747863 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality. — 28 Participants
Summary
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia. The intervention includes: neurologic examination by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the percentage of mild NE infants with evidence of brain injury defined by the presence of at least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period. Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home, death and long-term outcome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality. |
28 | — |
| SECONDARY Percentage of Infants With Seizures |
— | — |
| SECONDARY Length of Hospital Stay |
— | — |
| SECONDARY Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home |
— | — |
| SECONDARY Mortality Rate |
— | — |
Eligibility Criteria
Inclusion Criteria
- Infants with birth weight > or = 1800g and gestational age > or = 36 weeks AND
- Admission to neonatal intensive care unit (NICU) for possible hypothermia at < or = 6hr of life
Exclusion Criteria
- Infants with normal neurological evaluation
- Major congenital abnormalities
- Refusal of informed consent
- Infants who receive passive or active cooling prior to the NICU admission
- Infants that develop seizures or moderate/severe NE within the first 24 hr of life and are initiated on therapeutic hypothermia after 6 hr of life.
Data sourced from ClinicalTrials.gov (NCT01747863). 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. Informational only — not medical advice.