Prospective research on infants with mild encephalopathy: the PRIME study

Prempunpong, Chatchay; Chalak, Lina F.; Garfinkle, Jarred; Shah, Birju A.; Kalra, Vaneet Kumar; Rollins, Nancy; Boyle, R.; Nguyen, Kim Anh; Mir, Imran; Pappas, Athina; Montaldo, Paolo; Thayyil, Sudhin; Sánchez, Pablo J.; Shankaran, Seetha; Laptook, Abbot R.; Sant’Anna, Guilherme M.

doi:10.1038/jp.2017.164

Cited by 74 publications

(50 citation statements)

References 43 publications

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“…19,20 We noted injury on MRI in more than 40% of neonates in our cohort, consistent with that reported in 17 to 59% of neonates with mild HIE managed with or without TH. 10,12,[21][22][23] While most of the injury we noted was mild in severity, similar to others, we also identified moderate to severe injury on MRI scans in two neonates who presented with mild encephalopathy. 10,21 NDs of neonates with moderate to severe encephalopathy have been well characterized both before and after the advent of TH.…”

Section: Discussionsupporting

confidence: 89%

“…31 A recently completed prospective trial of TH in mild encephalopathy identified abnormal short-term outcomes (EEG, MRI, and discharge exam) in more than 50% of cooled infants. 23 While we do not have data on neurosensory examination at discharge, our data show that infants with mild HIE who underwent TH had outcomes comparable to the control group suggesting potential benefit from cooling.…”

Section: Discussionmentioning

confidence: 57%

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Neurodevelopmental Outcomes in Neonates with Mild Hypoxic Ischemic Encephalopathy Treated with Therapeutic Hypothermia

Rao

Trivedi²,

Distler

et al. 2019

Amer J Perinatol

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Objective To review developmental outcomes of neonates with mild hypoxic-ischemic encephalopathy (HIE) treated with therapeutic hypothermia (TH). Study Design Neonates ≥35 weeks' gestation with mild HIE/TH (TH group, n = 30) were matched with healthy term-born infants (control group, n = 30) and reviewed for the presence and severity of magnetic resonance imaging (MRI)-detected neurological injury. Neurodevelopmental outcomes were assessed using the Bayley Scales of Infant Development (BSID). Results MRI injury was present in 13/30 (43.3%) neonates (11 mild, 1 moderate, and 1 severe injuries) in the TH group. The mean (standard deviation [SD]) corrected age at BSID III was 29.3 (3.9) months in the controls compared with 14.7 (3.9) months in the TH group (p < 0.01). The mean (SD) cognitive, language, and motor composite scores in neonates in the TH group (n = 16, 53.3%) and control groups (n = 30, 100%) were 99.4 (17.1) versus 93.0 (12.3), (p = 0.15), 89.5 (15.5) versus 100.2 (18.4), (p = 0.054), and 93.1 (15.4) versus 100.8 (16.3) (p = 0.13), respectively. Conclusion Developmental outcomes of neonates with mild HIE/TH were similar to healthy, term-born neonates.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 57%

Neurodevelopmental Outcomes in Neonates with Mild Hypoxic Ischemic Encephalopathy Treated with Therapeutic Hypothermia

Rao

Trivedi²,

Distler

et al. 2019

Amer J Perinatol

View full text Add to dashboard Cite

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“…The inclusion of infants with moderate or severe encephalopathy was based on the presumption that they are most likely to develop permanent brain injury. However, recent studies have challenged this notion, suggesting that mild encephalopathy may be clinically benign . Therefore, there is an urgent need for additional diagnostic studies to effectively identify infants who will develop hypoxic brain injury so that life‐saving therapies can be offered to this at‐risk population.…”

mentioning

confidence: 99%

Novel Quantitative Contrast‐Enhanced Ultrasound Detection of Hypoxic Ischemic Injury in Neonates and Infants: Pilot Study 1

Hwang

Sridharan

Darge

et al. 2018

J of Ultrasound Medicine

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Objectives To investigate whether quantitative contrast‐enhanced ultrasound (CEUS) can accurately identify neonates and infants with hypoxic ischemic brain injury. Methods In this prospective cohort study, 8 neonates and infants with a suspicion of hypoxic ischemic injury were evaluated with CEUS. Results An interesting trend was observed in the central gray nuclei–to–cortex perfusion ratios. The ratios at the peak enhancement, wash‐in area under the curve, perfusion index, and maximum wash‐in slopes were lower in all of the affected cases compared to the normal group but not statistically significant given the small sample size (P = .0571). Additionally, when the central gray nuclei–to–cortex perfusion ratio was plotted for all time points along the time‐intensity curve, it was observed that the affected cases showed a trend that was qualitatively different from that of the normal cases. In the affected cases, the ratio time‐intensity curves either stayed below 1.0 for the entire enhancement period or reached 1.0 close to peak wash‐in before falling just below 1.0 for the remaining period of enhancement. However, in the unaffected patients, there was a steep wash‐in that crossed the 1.0 threshold and remained above 1.0 for most of the enhancement period. Conclusions Bedside CEUS is an easily obtainable brain‐imaging modality that has the potential to effectively identify infants and neonates with evolving brain injury. A larger prospective study evaluating the correlation between CEUS findings and the reference standard of diffusion‐ and perfusion‐weighted magnetic resonance imaging is needed to establish it as a diagnostic tool.

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“…The GS examiners were the most experienced as they had performed a modified Sarnat (>100 examinations) for study patients on all previous hypothermia trials. 7,15,16 In addition, the GS examiners attended the yearly Eunice Kennedy Shriver National Institute of Health and Child Health and Development (NICHD) workshop central training meetings and certified all the remaining attending neonatologists per the institution protocol. This encompassed multiple concomitant examinations followed by a test of two matching examination forms on all items and a subsequent yearly hands on refresher and teaching lecture.…”

Section: Examinersmentioning

confidence: 99%

“…Fetal acidemia was defined by umbilical cord gas with a pH ≤ 7.0 or base deficit (BD) ≥ −16 mmol/L, or postnatal blood gas in the first hour of age with pH ≤ 7.15 or BD ≥ −10 mmol/L and either a 10-min Apgar score ≤5 or need for assisted ventilation initiated at birth and continued for ≥10 min. 7,15,16 Per standard care, all infants born at PHHS have an umbilical cord blood gas obtained at birth. However, if cord gas was missing, a blood gas within the first hour of birth was obtained.…”

Section: Definitionsmentioning

confidence: 99%

Inter-rater reliability of the modified Sarnat examination in preterm infants at 32–36 weeks’ gestation

et al. 2019

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OBJECTIVE:To test the inter-rater reliability of the modified Sarnat neurologic examination in preterm neonates and to correlate abnormalities with the presence of perinatal acidosis. METHODS: Prospective study of 32-36 weeks' gestational age infants admitted to the neonatal intensive care unit. Each infant had two Sarnat examinations performed at <6 h, one by a gold standard (GS) study investigator, and the second either by (a) another GS examiner or (b) an attending physician (28 examiners), all blinded to clinical variables. Agreement was calculated using kappa (k) statistics. RESULTS: One hundred and two (9, fetal acidosis) infants underwent a modified Sarnat examination. Among GS examiners, agreement was excellent (k > 0.8) except for Moro, while among all examiners agreement was very good (k > 0.7) except for both Moro and tone. Subgroup analysis at 32-34 weeks' showed fair/poor Moro compared to excellent agreement at ≥35 weeks. Increasing abnormalities correlated with acidosis (r = −0.6, P < 0.01). CONCLUSIONS: Strong inter-rater reliability for the modified Sarnat was observed except for tone and Moro in preterm infants. Experience of the examiners resulted in improved reliability in tone, while for the Moro agreement improved only beyond 35 weeks. Findings suggest the need of adjustment of the examination form specific for preterm infants.

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Prospective research on infants with mild encephalopathy: the PRIME study

Abstract: A larger than expected proportion of mild NE infants with abnormal outcomes was observed. Future research should evaluate safety and efficacy of neuroprotection for mild NE.

Cited by 74 publications

References 43 publications

Neurodevelopmental Outcomes in Neonates with Mild Hypoxic Ischemic Encephalopathy Treated with Therapeutic Hypothermia

Neurodevelopmental Outcomes in Neonates with Mild Hypoxic Ischemic Encephalopathy Treated with Therapeutic Hypothermia

Novel Quantitative Contrast‐Enhanced Ultrasound Detection of Hypoxic Ischemic Injury in Neonates and Infants: Pilot Study 1

Inter-rater reliability of the modified Sarnat examination in preterm infants at 32–36 weeks’ gestation

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