Trial Outcomes & Findings for Prospective Research in Infants With Mild Encephalopathy (NCT NCT01747863)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

63 participants

Primary outcome timeframe

1 month

Results posted on

2025-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	Mild NE Infants with evidence of a perinatal event and NE who do not qualify for therapeutic hypothermia. 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.
Overall Study STARTED	63
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mild NE n=54 Participants Infants with evidence of a perinatal event and NE who do not qualify for therapeutic hypothermia. 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.
Age, Categorical <=18 years	54 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=54 Participants
Age, Categorical >=65 years	0 Participants n=54 Participants
Age, Continuous	39.4 Gestational age(weeks) STANDARD_DEVIATION 1.4 • n=54 Participants
Sex: Female, Male Female	22 Participants n=54 Participants
Sex: Female, Male Male	32 Participants n=54 Participants

PRIMARY outcome

Timeframe: 1 month

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.

Outcome measures

Outcome measures
Measure	Mild NE n=54 Participants Infants with evidence of a perinatal event and NE who do not qualify for therapeutic hypothermia. 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.
Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality.	28 Participants

SECONDARY outcome

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

Development of clinical or electrographic seizures

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Death during the hospitalization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18-22 months of age

Long-term outcomes (18-22 months of age): Severe disability if there is a Bayley III Cognitive score \< 70, severe cerebral palsy (CP), defined by the Gross Motor Function Classification System (GMFCS) grade level 3 to 5, blindness or profound hearing loss. Moderate disability will be defined as the Bayley Cognitive score is 70-84 and either seizures, moderate CP (defined by GMFCS grade level 2) or a hearing deficit requiring amplification to understand commands. Mild disability will be defined by a cognitive score 70-84, or a cognitive score ≥ 85 and either presence of mild or moderate CP (GMFCS grade levels 1 or 2), a seizure disorder or hearing loss with or without amplification. Normal will be defined as Bayley III Cognitive score ≥ 85 without any visual or hearing impairment, or CP.

Outcome measures

Outcome data not reported

Adverse Events

Mild NE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Guilherme Sant'Anna

Research Institute of the McGill University Health Center

Phone: (514) 412-4400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place