The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
NCT05756296, Not yet recruiting, McGill University Health Centre/Research Institute of the McGill University Health Centre
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era | ClinicalTrials.gov |
| NCT number | NCT05756296 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 198 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre | ClinicalTrials.gov |
| Conditions | Neonatal Encephalopathy, Therapeutic Hypothermia, Brain Injuries, Child Development | ClinicalTrials.gov |
| Interventions | Therapeutic hypothermia | ClinicalTrials.gov |
| First posted | 2023-03-06 | ClinicalTrials.gov |
| Last updated | 2023-10-23 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Higher order cognitive abilities | DAY 1 | Estimated IQ (Wechsler Abbreviated Scale of Intelligence 2nd ed. \[WASI-2\]), inhibition (Stroop test), planning (Tower - Delis-Kaplan Executive Function System \[D-KEFS\] and Rey-Osterrieth Complex Figure), impulsivity (Conner Continuous Performance Test - 3rd Ed \[CPT-3\]), working memory (Digit span), and word retrieval (verbal fluency - D-KEFS). Specific attentional skills; immediate (Digit Span) and sustained attention (CPT-3). Visual memory (Rey-Osterrieth Complex Figure). To characterize the ability to understand that others have thoughts, ideas, and feelings, and how emotion relates to social context, as well as the ability to recognize affect (Theory of Mind and Affect Recognition subtests). | ClinicalTrials.gov |
| Primary | Psycho-emotional abilities | DAY 1 | Self-esteem (Self-Concept Inventory from the Beck Youth Inventories-II), children's anxiety and emotional regulation (Spence Children's Anxiety Scale, the Multidimensional Anxiety Scale for Children, and the Difficulties in Emotion Regulation Scales). Predominance of profiles (e.g., predominantly affective, cognitive, or generalized) will be examined following an in-depth interpretation of the cognitive and psycho-emotional outcomes. | ClinicalTrials.gov |
| Primary | Motor skills | DAY 1 | Motor skills will be evaluated using the Movement Assessment Battery for Children-2nd Ed.in children without CP. In children with CP, motor skills will be evaluated with the Gross Motor Function Measure and subsequently be classified using the Gross Motor Function Classification System and the Manual Ability Classification System.Visual-motor integration will be assessed with the Berry-Buktenica Developmental Test of Visual-Motor Integration. | ClinicalTrials.gov |
| Primary | Functional profile | DAY 1 | Adaptive Behaviour Assessment Systems 3rd Ed. | ClinicalTrials.gov |
| Primary | Brain profile | DAY 1 | Quantitative MRI measuring structural brain integrity | ClinicalTrials.gov |
| Other | Sex | DAY 1 | determined by the physical appearance of genitalia recorded at birth | ClinicalTrials.gov |
| Other | Gender | DAY 1 | self-reported by the child | ClinicalTrials.gov |
| Other | Socio-economic status | DAY 1 | Maternal Education, employment, income and ethnicity | ClinicalTrials.gov |
| Other | Medical history of child | DAY 1 | prenatal, perinatal, and postnatal factors extracted from existing clinical and research databases | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Continuous Performance Test | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)