Prospective Research in Infants With Mild Encephalopathy

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.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Brain Injury
• Neonatal Seizure

Interventions

OTHER

Neurologic examination

Neurologic examination includes: (1) neurologic examination using modify Sarnat score at \</= 6 hrs of age, 24 hrs and at discharge home, (2) aEEG at 6 ± 3 hrs of age, (3) Brain MRI before discharge home to 30 days of age.

Sponsors & Collaborators

• Brown University

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• Mahidol University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Guilherme Sant'Anna, MD · McGill University

• Lina Chalak, MD · University of Texas

• Abbot Laptook, MD · Brown University

• Seetha Shankaran, MD · Wayne State University

• Chatchay Prempunpong, MD · Mahidol University

• Sudhin Thayyil, MD · Imperial College London

• Pablo Sanchez, MD · Ohio State University

• Pablo Sanchez, MD · The Ohio Stage University

• Guilherme Sant'Anna, MD · McGill University

Eligibility

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2015-12-31

Completion

2017-06-30

Countries

• United States
• Canada
• Thailand
• United Kingdom

Study Locations