Prospective Research in Infants With Mild Encephalopathy (PRIME)
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of life) 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 life, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aEEG) at ≤ 6 hrs of life, brain MRI 7-30 days of life 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.
Other: Neurologic examination
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Research in Infants With Mild Encephalopathy: the PRIME Study.|
- Percentage of infants with evidence of neurological dysfunction, brain injury and/or abnormality. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Evidence of neurological dysfunction/injury/abnormality will be defined by any of these 3 criteria, as follows:
- MRI = NRN score of pattern of injury > 0,
- aEEG = abnormal background pattern on aEEG (voltage or background pattern) at ≤ 6hrs of age.
- Any abnormality on the neurological at discharge exam.
- Percentage of infants with seizures [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]Development of clinical or electrographic seizures
- Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
- Percentage of infants who need gavage feeds or gastrostomy at discharge home [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
- Mortality rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]Death during the hospitalization
- Long-term neurodevelopment [ Time Frame: 18-22 months of age ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Infants with evidence of a perinatal event and NE who do not qualify for therapeutic hypothermia.
Other: Neurologic examination
Neurologic examination includes: (1) neurologic examination using modify Sarnat score at </= 6 hrs of life, 24 hrs and at discharge home, (2) aEEG at </= 6 hrs of life, (3) Brain MRI at 7-30 days of life.
Globally, an estimated 1.8 to 7.7 infants per 1000 live term births suffer from perinatal asphyxia, which remains an important cause of neonatal encephalopathy (NE) and neurodevelopmental impairment. Over the last six years, several randomized control trials have demonstrated that prolonged and moderate therapeutic hypothermia (TH) reduces the rate of death or disability at 18 months of age among infants who survived. In these trials, infants were eligible if there was evidence of perinatal hypoxia-ischemia and a moderate or severe degree of encephalopathy on neurological evaluation performed at ≤ 6 hrs of age. However, it has been recognized that the level of NE may change over time. Preliminary and unpublished observations from our group indicated that some infants who were not classified as moderate or severe NE had neurological abnormalities at discharge or evidence of brain injury on MRI performed during the neonatal period. Unfortunately, precise data on the outcomes of this specific population is not clear. Since TH is not offered to this population, the outcomes of infants that do not qualify for TH based on neurological evaluation performed ≤ 6 hrs of life requires a more precise investigation.
|Contact: Chatchay Prempunpong, MD||1 514 412 4400 ext email@example.com|
|Contact: Lina Chalak, MD||1-214-730-5437||Lina.Chalak@utsouthwestern.edu|
|United States, Michigan|
|Wayne State University||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Seetha Shankaran, MD 313-745-1436 firstname.lastname@example.org|
|Principal Investigator: Seetha Shankaran, MD|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02905|
|Contact: Abbot Laptook, MD 401-274-1122 ext 1221 email@example.com|
|Principal Investigator: Abbot Laptook, MD|
|United States, Texas|
|University of Texas Southwestern||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Pablo Sanchez, MD 214-730-5437 Pablo.Sanchez@utsouthwestern.edu|
|Contact: Lina Chalak, MD 1-214-730-5437 Lina.Chalak@utsouthwestern.edu|
|Principal Investigator: Pablo Sanchez, MD|
|Principal Investigator: Lina Chalak, MD|
|Montreal Children's Hospital||Recruiting|
|Montreal, Quebec, Canada, H3H 1P3|
|Contact: Guilherme Sant' Anna, MD 1-514-412-4400 ext 23489 firstname.lastname@example.org|
|Contact: Chatchay Prempunpong, MD 1-514-412-4400 ext 23063 email@example.com|
|Principal Investigator: Chatchay Prempunpong, MD|
|Principal Investigator: Guilherme Sant'Anna, MD|
|University College London||Recruiting|
|London, United Kingdom, WC1E 6AU|
|Contact: Sudhin Thayyil, MD +44 (0) 203-108-2009 firstname.lastname@example.org|
|Principal Investigator: Sudhin Thayyil, MD|
|Principal Investigator:||Chatchay Prempunpong, MD||McGill University Health Center|
|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:||Sudhin Thayyil, MD||University College, London|
|Study Director:||Pablo Sanchez, MD||University of Texas|
|Study Chair:||Guilherme Sant'Anna, MD||McGill University Health Center|