Prospective Research in Infants With Mild Encephalopathy

NCT01747863 | Completed Results

• 2 other identifiers: PRIME0112-108-PED
• Study Type: observational
• Target: 63
• Locations: 4 countries
• Sites: 7

Brief 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

Keywords

Hypoxic Ischemic encephalopathy

Outcome Measures

Primary Outcomes (1)

• Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality.

  Evidence of neurological dysfunction/injury/abnormality will be defined by any of these 3 criteria, as follows: 1. MRI = Brain MRI score of pattern of injury (NICHD-NRN) \> 0, 2. aEEG = abnormal background pattern on aEEG (voltage or background pattern) at 6 ± 3 hrs of age. 3. Any abnormality on the neurological at discharge exam.

  1 month

Secondary Outcomes (4)

• Percentage of Infants With Seizures

  Participants will be followed for the duration of hospital stay, an expected average of 3 days

• Length of Hospital Stay

  Participants will be followed for the duration of hospital stay, an expected average of 3 days

• Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home

  Participants will be followed for the duration of hospital stay, an expected average of 3 days

• Mortality Rate

  Participants will be followed for the duration of hospital stay, an expected average of 3 days

Other Outcomes (1)

• Long-term Neurodevelopment

  18-22 months of age

Study Arms (1)

Mild NE

Infants with evidence of a perinatal event and NE who do not qualify for therapeutic hypothermia.

Other: Neurologic examination

Interventions

Neurologic examination OTHER

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.

Mild NE

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with evidence of a perinatal event and NE who do not qualify for therapeutic hypothermia. NE will be defined as the presence of abnormal neurological findings on the modified Sarnat Score performed at ≤ 6 hrs of life. Evidence of a perinatal event will include criteria described in details in the whole body hypothermia trial (NEJM, 2005). The level of NE will be defined by the neurological exam performed by certified neonatologists working at the 6 centers.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Brown University: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Wayne State University: collaborator
• Mahidol University: collaborator
• Ohio State University: collaborator
• Imperial College London: collaborator

Study Sites (7)

Wayne State University

Detroit, Michigan, 48201, United States

Location

The Ohio Stage University - Nationwide Children's Hospital

Columbus, Ohio, 43205-2664, United States

Location

Brown University

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern

Dallas, Texas, 75235, United States

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Mahidol University - Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Imperial College London

London, W12 0HS, United Kingdom

Location

Related Publications (2)

• Chalak LF, Adams-Huet B, Sant'Anna G. A Total Sarnat Score in Mild Hypoxic-ischemic Encephalopathy Can Detect Infants at Higher Risk of Disability. J Pediatr. 2019 Nov;214:217-221.e1. doi: 10.1016/j.jpeds.2019.06.026. Epub 2019 Jul 10.

  PMID: 31301853 DERIVED

• Prempunpong C, Chalak LF, Garfinkle J, Shah B, Kalra V, Rollins N, Boyle R, Nguyen KA, Mir I, Pappas A, Montaldo P, Thayyil S, Sanchez PJ, Shankaran S, Laptook AR, Sant'Anna G. Prospective research on infants with mild encephalopathy: the PRIME study. J Perinatol. 2018 Jan;38(1):80-85. doi: 10.1038/jp.2017.164. Epub 2017 Nov 2.

  PMID: 29095433 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Guilherme Sant'Anna
• Organization: Research Institute of the McGill University Health Center

guilherme.santanna@mcgill.ca

(514) 412-4400

Study Officials

• Guilherme Sant'Anna, MD

  McGill University

  PRINCIPAL INVESTIGATOR

• Lina Chalak, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Abbot Laptook, MD

  Brown University

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Chatchay Prempunpong, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Sudhin Thayyil, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Pablo Sanchez, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Pablo Sanchez, MD

  The Ohio Stage University

  STUDY DIRECTOR

• Guilherme Sant'Anna, MD

  McGill University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2017
• Last Updated: January 28, 2025
• Results First Posted: January 28, 2025

Record last verified: 2024-12

Locations

TH (1); CA (1); US (4); GB (1)