Seven- to eight-year follow-up of the CoolCap trial of head cooling for neonatal encephalopathy

Guillet, Ronnie; Edwards, AD; Thoresen, Marianne; Ferriero, Donna M.; Gluckman, Peter D.; Whitelaw, Andrew; Gunn, Alistair J.

doi:10.1038/pr.2011.30

Cited by 159 publications

(100 citation statements)

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“…25 Growth is an excellent indicator of the overall health of children and there are currently no data available on the growth outcomes of Mod/Sev HIE survivors in the era of hypothermia therapy. 3,7 The over-arching goal of this secondary analysis is to use data collected from birth to 6 to 7 years within a cohort of term Mod/Sev HIE survivors with Mod/Sev CP or without CP (No CP) to examine growth, cognitive development, and rehospitalization rates.The specific aims of this study were (1) to compare the longitudinal weight (WT), head circumference (HC), and length (LT) or height (HT) measurements, percentiles, and z scores for the 2 study groups from birth to 6 to 7 years of age, and (2) to identify factors protective of and associated with slow growth. We hypothesized that children with Mod/Sev CP versus those with No CP would have slower growth trajectories between birth and 6 to 7 years; lower WT, HT, and HC percentiles; and lower z scores at 6 to 7 years.…”

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confidence: 99%

Cerebral Palsy and Growth Failure at 6 to 7 Years

et al. 2013

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WHAT'S KNOWN ON THIS SUBJECT: Surviving infants with hypoxic ischemic encephalopathy (HIE) treated with hypothermia have decreased rates of CP in childhood. CP is associated with increased risk of slow growth. WHAT THIS STUDY ADDS:Term children with HIE who develop moderate/severe CP are at high risk of progressive impaired growth, high rates of cognitive impairment, and rehospitalizations from infancy to school age. Gastrostomy tube placement to facilitate feeds is protective of slow growth. abstract OBJECTIVE: To evaluate the association between severity of cerebral palsy (CP) and growth to 6 to 7 years of age among children with moderate to severe (Mod/Sev) hypoxic ischemic encephalopathy (HIE). It was hypothesized that children with Mod/Sev CP would have poorer growth, lower cognitive scores, and increased rehospitalization rates compared with children with no CP (No CP).METHODS: Among 115 of 122 surviving children followed in the hypothermia trial for neonatal HIE, growth parameters and neurodevelopmental status at 18 to 22 months and 6 to 7 years were available. Group comparisons (Mod/Sev CP and No CP) with unadjusted and adjusted analyses for growth ,10th percentile and z scores by using Fisher' s exact tests and regression modeling were conducted. RESULTS:Children with Mod/Sev CP had high rates of slow growth and cognitive and motor impairment and rehospitalizations at 18 to 22 months and 6 to 7 years. At 6 to 7 years of age, children with Mod/ Sev CP had increased rates of growth parameters ,10th percentile compared with those with No CP (weight, 57% vs 3%; height, 70% vs 2%; and head circumference, 82% vs 13%; P , .0001). Increasing severity of slow growth was associated with increasing age (P , .04 for weight, P , .001 for length, and P , .0001 for head circumference). Gastrostomy feeds were associated with better growth.CONCLUSIONS: Term children with HIE who develop Mod/Sev CP have high and increasing rates of growth ,10th percentile by 6 to 7 years of age. These findings support the need for close medical and nutrition management of children with HIE who develop CP. Infants who experience moderate or severe hypoxic ischemic encephalopathy (HIE) are at increased risk of neurodevelopmental disability and moderate tosevere(Mod/Sev)cerebralpalsy(CP). [1][2][3][4][5][6][7][8] Slow growth is more common in children with Mod/Sev CP. 9,10 Decreased growth velocity in children with CP may be related to decreased oromotor coordination with suboptimal nutritional intake secondary to impaired chewing and swallowing, recurrent aspiration, chronic reflux, inadequate provision of required nutritional intake, increased caloric expenditure due to the excessive muscle contraction in spasticity for children with ambulatory CP, and the possibility of growth hormone deficiency. [10][11][12][13][14][15][16][17][18] In addition, comorbidities of CP, including gastroesophageal reflux and aspiration, are associated with slow growth and increased risk of rehospitalization. [19][20][21][22][23] Vigilance regarding growth of ...

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Cerebral Palsy and Growth Failure at 6 to 7 Years

et al. 2013

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“…16,17 Because the follow-up rate at 7 to 8 years of age was only 50% in the CoolCap trial, there were insufficient data to ascertain the long-term risk or benefits of selective head cooling. In the NICHD follow-up study, there was no statistical difference in the composite primary outcome of death or IQ <70 at 6 to 7 years of age between the treated and usual care cohorts (P = .06).…”

Section: Preliminary Studiesmentioning

confidence: 99%

Hypothermia and Neonatal Encephalopathy

2014

Pediatrics

294

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Data from large randomized clinical trials indicate that therapeutic hypothermia, using either selective head cooling or systemic cooling, is an effective therapy for neonatal encephalopathy. Infants selected for cooling must meet the criteria outlined in published clinical trials. The implementation of cooling needs to be performed at centers that have the capability to manage medically complex infants. Because the majority of infants who have neonatal encephalopathy are born at community hospitals, centers that perform cooling should work with their referring hospitals to implement education programs focused on increasing the awareness and identification of infants at risk for encephalopathy, and the initial clinical management of affected infants.

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“…Follow-up studies of three RCTs suggested some benefit of TH even at early school age (Guillet et al, 2012;Shankaran et al, 2012;Azzopardi et al, 2014). TH was recommended as a standard of care for moderate to severe neonatal encephalopathy for the first time in the Consensus Statement and Treatment Recommendation on Cardio-Pulmonary Resuscitation revised in October 2010 (2010 CoSTR) (Perlman et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

The Baby Cooling Project of Japan to Implement Evidence-Based Neonatal Cooling

Iwata

Tamura

Iwata

et al. 2014

Therapeutic Hypothermia and Temperature Management

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Therapeutic hypothermia was first recommended as a standard of care by international guidelines in 2010. However, at that time, the number of centers capable of providing standard cooling was limited even in Japan. The aim of this project was to implement a nationwide network of evidence-based cooling within 3 years. A taskforce was formed in June 2010 to undergo the primary nationwide practice survey, design of action plans, and the appraisal of interventions by involving all registered level-II/III neonatal intensive care units in Japan. Based on findings from the primary survey, aggressive action plans were introduced that focused on the formulation of clinical recommendations, facilitation of educational events, and opening of an online case registry. Findings from the follow-up survey ( January 2013) were compared with the results from the primary survey ( June 2010). Four workshops and three consensus meetings were held to formulate clinical recommendations, which were followed by the publication of practical textbooks, large-scale education seminars, and implementation of a case registry. A follow-up survey covering 253 units (response rate: 89.1%) showed that cooling centers increased from 89 to 135. Twelve prefectures had no cooling centers in 2010, whereas all 47 prefectures had at least one in 2013. In cooling centers, adherence to the standard cooling protocols and the use of servo-controlled cooling devices improved from 20.7% to 94.7% and from 79.8% to 98.5%, respectively. A rapid improvement in the national provision of evidence-based cooling was achieved. International consensus guidelines coupled with domestic interventions might be effective in changing empirical approaches to evidence-based practice.

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Seven- to eight-year follow-up of the CoolCap trial of head cooling for neonatal encephalopathy

Cited by 159 publications

References 16 publications

Cerebral Palsy and Growth Failure at 6 to 7 Years

Cerebral Palsy and Growth Failure at 6 to 7 Years

Hypothermia and Neonatal Encephalopathy

The Baby Cooling Project of Japan to Implement Evidence-Based Neonatal Cooling

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