Clinical trialNCT01747863CompletedObservational

Prospective Research in Infants With Mild Encephalopathy

SponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreEnrollment63Brain InjuryHypoxic-Ischemic EncephalopathyNeonatal Seizure

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Abbot Laptook, MD
Brown University
Principal Investigator
clinicaltrials.gov ↗
Chatchay Prempunpong, MD
Mahidol University
Principal Investigator
clinicaltrials.gov ↗
Guilherme Sant'Anna, MD
McGill University
Principal Investigator
clinicaltrials.gov ↗
Guilherme Sant'Anna, MD
McGill University
Study Chair
clinicaltrials.gov ↗
Lina Chalak, MD
University of Texas
Principal Investigator
clinicaltrials.gov ↗
Pablo Sanchez, MD
Ohio State University
Principal Investigator
clinicaltrials.gov ↗
Pablo Sanchez, MD
The Ohio Stage University
Study Director
clinicaltrials.gov ↗
Seetha Shankaran, MD
Wayne State University
Principal Investigator
clinicaltrials.gov ↗
Sudhin Thayyil, MD
Imperial College London
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Montreal Children'S Hospital
Montreal, Quebec, Canada

Thailand

Mahidol University - Ramathibodi Hospital
Bangkok, Thailand

United Kingdom

Imperial College London
London, United Kingdom

United States

Wayne State University
Detroit, Michigan, United States
the Ohio Stage University - Nationwide Children'S Hospital
Columbus, Ohio, United States
Brown University
Providence, Rhode Island, United States
University of Texas Southwestern
Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 2012
Primary completion: 31 Dec 2015
Completion: 30 Jun 2017
Last update posted: 28 Jan 2025
Registered enrollment: 63
Registry id: NCT01747863

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.