About: Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial

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About: Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial
Creator	Bhandari, Vineet Zhao, Guomao Buhimschi, Catalin Buhimschi, Irina Rogers, Lynette Lipkind, Heather Ozan Bahtiyar, Mert Abdelghany, Osama Dulay, Antonette Mieth, Saya Razeq, Sonya Schneider, Lydia
source	Medline; PMC
abstract	BACKGROUND: Intrauterine infection and/or inflammation (Triple I) is an important cause of preterm birth (PTB) and adverse newborn outcomes. N-acetylcysteine (NAC) is a Food and Drug Administration (FDA)-approved drug safely administered to pregnant women with acetaminophen toxicity. METHODS: We conducted a single-center, quadruple-blind, placebo-controlled trial of pregnant women with impending PTB due to confirmed Triple I. Participants (n = 67) were randomized to an intravenous infusion of NAC or placebo mimicking the FDA-approved regimen. Outcomes included clinical measures and mechanistic biomarkers. RESULTS: Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34). Fewer NAC-exposed newborns developed two or more prematurity-related severe morbidities [NAC: 21% vs. placebo: 47%, relative risk, 0.45; 95% confidence interval (CI) 0.21–0.95] with the strongest protection afforded against bronchopulmonary dysplasia (BPD, NAC: 3% vs. placebo: 32%, relative risk, 0.10; 95% CI: 0.01–0.73). These effects were independent of gestational age, birth weight, sex, or race. Umbilical cord plasma NAC concentration correlated directly with cysteine, but not with plasma or whole blood glutathione. NAC reduced the placental expression of histone deacetylase-2, suggesting that epigenetic mechanisms may be involved. CONCLUSIONS: These data provide support for larger studies of intrapartum NAC to reduce prematurity-related morbidity. IMPACT: In this randomized clinical trial of 65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight. Administration of NAC in amniocentesis-confirmed Triple I resulted in a remarkably lower incidence of BPD. As prior studies have not shown a benefit of postnatal NAC in ventilated infants, our trial highlights the critical antenatal timing of NAC administration. Repurposing of NAC for intrapartum administration should be explored in larger clinical trials as a strategy to improve prematurity-related outcomes and decrease the incidence of BPD.
has issue date	2020-08-20(xsd:dateTime)
bibo:doi	10.1038/s41390-020-01106-w
bibo:pmid	32818949
has license	no-cc
sha1sum (hex)	f052346b7e315b7297f58beaf61083ab2353e04c
schema:url	https://doi.org/10.1038/s41390-020-01106-w
resource representing a document's title	Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial
has PubMed Central identifier	PMC7451831
has PubMed identifier	32818949
schema:publication	Pediatr Res
resource representing a document's body	covid:f052346b7e315b7297f58beaf61083ab2353e04c#body_text
is schema:about of	named entity 'conducted' named entity 'biomarkers' named entity 'mechanistic' named entity 'sex' named entity 'inflammation' named entity 'infection' named entity 'inflammation' named entity 'Triple' named entity 'BUT' named entity 'ADMINISTERED' named entity 'EXPOSED' named entity 'CONCENTRATION' named entity 'CONFIDENCE INTERVAL' named entity 'INVOLVED' named entity 'FOOD AND DRUG ADMINISTRATION' named entity '0.45' named entity 'GESTATIONAL AGE' named entity 'MORBIDITIES' named entity 'TO REDUCE' named entity 'RACE' named entity 'SEX' named entity 'INCLUDED' named entity 'STUDIES' named entity 'BIRTH WEIGHT' named entity 'BLIND' named entity 'CONCLUSIONS' named entity 'WHOLE BLOOD' named entity 'IS A' named entity 'confidence interval' named entity 'severe' named entity 'intravenous infusion' named entity 'These' named entity 'newborns' named entity 'provide' named entity 'placebo' named entity 'mechanisms' named entity 'morbidities' named entity 'support' named entity 'premature infants' named entity 'prematurity' named entity 'cysteine' named entity 'placental' named entity '0.45' named entity 'epigenetic mechanisms' named entity 'gestational age' named entity 'placebo-controlled trial' named entity 'N-acetylcysteine' named entity 'resuscitation' named entity 'placebo' named entity '95% confidence interval' named entity 'inflammation' named entity 'N-acetylcysteine' named entity 'Antenatal' named entity 'gold standard' named entity 'placebo' named entity 'fetal tissue' named entity 'funisitis' named entity 'sample size' named entity 'unblinding' named entity 'leukocytosis' named entity 'neonatal' named entity 'idiopathic' named entity 'HDAC2' named entity 'fetal tissue' named entity 'C.S.B.' named entity 'acid-base' named entity 'sepsis' named entity 'clinical trial' named entity 'CYS' named entity 'neonatal'

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