Prevention of intraventricular hemorrhage by indomethacin in male preterm infants

Ment, Laura R.; Vohr, Betty R.; Makuch, Robert W.; Westerveld, Michael; Katz, Karol H.; Schneider, Karen; Duncan, Charles C.; Ehrenkranz, Richard A.; Oh, William; Philip, Alistair G. S.; Scott, David T.; Allan, Walter C.

doi:10.1016/j.jpeds.2004.07.035

Cited by 133 publications

(96 citation statements)

References 6 publications

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“…An association between indomethacin use and decreased white matter lesions has also been found on MRI (25,26). And, favorable neurodevelopmental outcomes have recently been reported among 4.5 and 8 year old children who were originally treated with prophylactic indomethacin in the Ment-trial in 1994 (27,28).…”

Section: Comments and Conclusionmentioning

confidence: 77%

“…We suggest that clinicians take into account the following considerations when making a decision about whether to use prophylactic indomethacin: 1) two large randomized controlled trials (11,16) documented the beneficial effects of this intervention in reducing the incidence of early neonatal morbidities (severe ICH, PDA and PDA ligation), in the absence of clinically significant adverse effects; 2) the negative conclusions of the TIPP-trial may have been due to an anticipated effect size that was excessively large for the population studied; 3) less use of this intervention in the Neonatal Network was associated with an increased incidence of surgical PDA ligation; and 4) neuroimaging data (25,26) and longer term neurodevelopmental outcome data (24,27,28) are both reassuring with regards to a lack of adverse effects and possible benefits of prophylactic indomethacin on neurodevelopmental outcome. Indomethacin prophylaxis may be a reasonable choice in intensive care nurseries where ICH and PDA are frequent management problems.…”

Section: Comments and Conclusionmentioning

confidence: 99%

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Indomethacin Prophylaxis for Preterm Infants: The Impact of 2 Multicentered Randomized Controlled Trials on Clinical Practice

Clyman¹,

Saha²,

Jobe³

et al. 2007

The Journal of Pediatrics

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Objectives-Two multicentered RCTs in premature infants TIPP, 2001) found beneficial effects of indomethacin prophylaxis on the incidences of patent ductus arteriosus (PDA), PDA ligation, and severe intracranial hemorrhage (ICH). The Ment-trial recommended its use. The TIPP-trial failed to find a benefit in its primary outcome (improved survival/ neurodevelopmental outcome). This negative result may have discouraged prophylactic indomethacin use.Study Design-We used the NICHD Neonatal Network Registry to determine the association between the two trials and the use of prophylactic indomethacin. We also statistically assessed the assumptions that led to the TIPP trial's negative results.Results-Use of prophylactic indomethacin among Network clinicians increased after publication of the Ment-trial and decreased after the TIPP-trial. Analysis of the TIPP-trial showed that the primary outcome's anticipated effect size (≥20%) was too large; a smaller effect size (<3%) would have been more appropriate based on the incidence of ICH in their population, and its association with neurodevelopmental outcome.. Conclusions-Two multicenteredRCTs were associated with changes in indomethacin prophylaxis. Following the Ment-trial, its use increased. Following the TIPP-trial, which reported negative results based on too large an anticipated effect size, its use decreased.

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Section: Comments and Conclusionmentioning

confidence: 77%

Section: Comments and Conclusionmentioning

confidence: 99%

Indomethacin Prophylaxis for Preterm Infants: The Impact of 2 Multicentered Randomized Controlled Trials on Clinical Practice

Clyman¹,

Saha²,

Jobe³

et al. 2007

The Journal of Pediatrics

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“…Это предполагает гендер-дифференцированные механизмы нейропротекторной защиты при ГИП, и новые разработки должны вестиcь с учетом данного обстоятельства. По крайней мере одна работа в области клинической фармакотерапии уже под-твердила это: индометацин вдвое снижал последствия внутрижелудочковых кровоизлияний, элиминировал па-ренхиматозные кровоизлияния у недоношенных ново-рожденных мальчиков и улучшал у них вербальные ког-нитивные показатели в возрасте от 3 до 8 лет, и в то же время был неэффективен у девочек [46].…”

Section: патофизиологические механизмы гипоксически-ишемических поражunclassified

Recent Information on the Pathogenesis and Treatment of Hypoxic-Ischemic Brain Lesions in Newborns

Каркашадзе¹,

Аникин²,

Зимина³

et al. 2016

Pediatr. farmakol.

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ВВЕДЕНИЕ Общемировой научно-технический прогресс в отно-шении исследовательских технологий за последние де-сятилетия привел к качественному и количественно-му скачку нейронаук. Наиболее активно наполняется новыми данными поле фундаментальных представлений о развитии головного мозга, что обусловливает интересы ученых к таким областям медицины, как перинатальная неврология и неврология раннего возраста. Несмотря на расширение представлений о вкладе генетической составляющей, по-прежнему большое внимание уделяет-ся изучению прямых патофизиологических механизмов гипоксически-ишемических поражений (ГИП) головного мозга у новорожденных. К настоящему моменту накоплен массив новых данных в этой области, что подталкивает медицину к внедрению передовых лечебных технологий.Цель работы -провести литературный обзор совре-менных научных данных о механизмах гипоксически-ише-мических повреждений мозга у новорожденных и разра-батываемых на их основании новых методов лечения. ПАТОФИЗИОЛОГИЧЕСКИЕ МЕХАНИЗМЫ ГИПОКСИЧЕСКИ-ИШЕМИЧЕСКИХ ПОРАЖЕНИЙТрадиционно основные лечебные тактики в острый период гипоксически-ишемических перинатальных поражений головного мозга (ГИППГМ) предусма-тривают медикаментозное поддержание сердечно-легочных функций и противосудорожную защиту [1]. Послед ние достижения в раскрытии патофизиологи-ческих механизмов непосредственно ГИП дают опору для поиска и внедрения новых лечебных технологий. У доношенных детей основным прямым механизмом ГИП является внутриутробная асфиксия, вызванная проблемами кровообращения, в том числе в области плацентарных артерий, отслойкой плаценты или вос-палительным процессом. За этим следуют снижение объема кислорода и углекислого газа в крови и тяже-лый лактат-ацидоз. Выраженное снижение сердечного выброса в условиях гипоксии, называемое гипоксией-ишемией, в течение 12-36 ч приводит к поражению головного мозга [2].

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“…31 Recent analysis of children at 4 ½ and 8 years of age who were treated with indomethacin prophylaxis at birth showed favorable neurodevelopmental outcome vs those treated with placebo. 32,33 Long-term neurological outcome in infants who received ibuprofen lysine is not yet available since it has only been approved for use since 2006.…”

Section: Treatment Options For Pdamentioning

confidence: 99%

Treatment of patent ductus arteriosus: indomethacin or ibuprofen?

Sekar

Corff

2008

J Perinatol

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Persistent patent ductus arteriosus (PDA) in preterm infants can result in serious hemodynamic changes causing respiratory, gastrointestinal and renal morbidities if not treated within the first week of life. The treatment options available are a conservative approach, pharmacological treatment with cyclo-oxygenase (COX) inhibitors and surgical ligation. The COX inhibitors approved for use in the United States are indomethacin and ibuprofen lysine. Both of these drugs are equally effective in closing the PDA. Subtle differences exist between these two preparations. Indomethacin has a protective effect on the incidence of intraventricular hemorrhage (IVH) but reduces the blood flow to the kidneys and the brain. Ibuprofen is less toxic but has no effect on IVH. Efficacy of pharmacological treatment is influenced by timing of initiation of therapy. Surgical treatment is the only option when pharmacological treatment fails to close the PDA in symptomatic infants. Long-term neurological and respiratory morbidities are associated with surgical ligation. This paper reviews these medical considerations in the treatment options for PDA in premature infants.

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Prevention of intraventricular hemorrhage by indomethacin in male preterm infants

Cited by 133 publications

References 6 publications

Indomethacin Prophylaxis for Preterm Infants: The Impact of 2 Multicentered Randomized Controlled Trials on Clinical Practice

Indomethacin Prophylaxis for Preterm Infants: The Impact of 2 Multicentered Randomized Controlled Trials on Clinical Practice

Recent Information on the Pathogenesis and Treatment of Hypoxic-Ischemic Brain Lesions in Newborns

Treatment of patent ductus arteriosus: indomethacin or ibuprofen?

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