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Systematic review

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Nitric oxide for respiratory failure in infants born at or near term

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Journal Cochrane Database of Systematic Reviews
Year 2017
Links Pubmed DOI PubMed Central

This article is included in 1 Broad synthesis 20 Broad syntheses (1 reference)

This article includes 20 Primary studies 20 Primary studies (20 references)

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Background: Nitric oxide (NO) is a major endogenous regulator of vascular tone. Inhaled nitric oxide (iNO) gas has been investigated as treatment for persistent pulmonary hypertension of the newborn. Objectives: To determine whether treatment of hypoxaemic term and near-term newborn infants with iNO improves oxygenation and reduces rate of death and use of extracorporeal membrane oxygenation (ECMO), or affects long-term neurodevelopmental outcomes. Search methods: We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), MEDLINE via PubMed (1966 to January 2016), Embase (1980 to January 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to January 2016). We searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We contacted the principal investigators of studies published as abstracts to ascertain the necessary information. Selection criteria: Randomised studies of iNO in term and near-term infants with hypoxic respiratory failure, with clinically relevant outcomes, including death, use of ECMO and oxygenation. Data collection and analysis: We analysed trial reports to assess methodological quality using the criteria of the Cochrane Neonatal Review Group. We tabulated mortality, oxygenation, short-term clinical outcomes (particularly use of ECMO) and long-term developmental outcomes. Statistics: For categorical outcomes, we calculated typical estimates for risk ratios and risk differences. For continuous variables, we calculated typical estimates for weighted mean differences. We used 95% confidence intervals and assumed a fixed-effect model for meta-analysis. Main results: We found 17 eligible randomised controlled studies that included term and near-term infants with hypoxia. Ten trials compared iNO versus control (placebo or standard care without iNO) in infants with moderate or severe severity of illness scores (Ninos 1996; Roberts 1996; Wessel 1996; Davidson 1997; Ninos 1997; Mercier 1998; Christou 2000; Clark 2000; INNOVO 2007; Liu 2008). Mercier 1998 compared iNO versus control but allowed back-up treatment with iNO for infants who continued to satisfy the same criteria for severity of illness after two hours. This trial enrolled both preterm and term infants but reported most results separately for the two groups. Ninos 1997 studied only infants with congenital diaphragmatic hernia. One trial compared iNO versus high-frequency ventilation (Kinsella 1997). Six trials enrolled infants with moderate severity of illness scores (oxygenation index (OI) or alveolar-arterial oxygen difference (A-aDO2)) and randomised them to immediate iNO treatment or iNO treatment only after deterioration to more severe criteria (Barefield 1996; Day 1996; Sadiq 1998; Cornfield 1999; Konduri 2004; Gonzalez 2010). Inhaled nitric oxide appears to have improved outcomes in hypoxaemic term and near-term infants by reducing the incidence of the combined endpoint of death or use of ECMO (high-quality evidence). This reduction was due to a reduction in use of ECMO (with number needed to treat for an additional beneficial outcome (NNTB) of 5.3); mortality was not affected. Oxygenation was improved in approximately 50% of infants receiving iNO. The OI was decreased by a (weighted) mean of 15.1 within 30 to 60 minutes after the start of therapy, and partial pressure of arterial oxygen (PaO2) was increased by a mean of 53 mmHg. Whether infants had clear echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN) did not appear to affect response to iNO. Outcomes of infants with diaphragmatic hernia were not improved; outcomes were slightly, but not significantly, worse with iNO (moderate-quality evidence). Infants who received iNO at less severe criteria did not have better clinical outcomes than those who were enrolled but received treatment only if their condition deteriorated. Fewer of the babies who received iNO early satisfied late treatment criteria, showing that earlier iNO reduced progression of the disease but did not further decrease mortality nor the need for ECMO (moderate-quality evidence). Incidence of disability, incidence of deafness and infant development scores were all similar between tested survivors who received iNO and those who did not. Authors' conclusions: Inhaled nitric oxide is effective at an initial concentration of 20 ppm for term and near-term infants with hypoxic respiratory failure who do not have a diaphragmatic hernia. © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Systematic review

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Extracorporeal membrane oxygenation for severe respiratory failure in newborn infants

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Journal Cochrane database of systematic reviews (Online)
Year 2008
Links Pubmed DOI

This article is included in 1 Broad synthesis 9 Broad syntheses (1 reference)

This article includes 9 Primary studies 9 Primary studies (9 references)

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Background: Neonatal extracorporeal membrane oxygenation (ECMO) is a complex procedure of life support used in severe but potentially reversible respiratory failure in term infants. Although the number of babies eligible for ECMO is small and the use of ECMO invasive and potentially expensive, its benefits may be high. Objectives: To determine whether ECMO used for neonatal infants with severe respiratory failure is clinically and cost effective compared to conventional ventilatory support. Search strategy: The Cochrane Neonatal Group Specialised Register, the Cochrane Controlled Trials Register, and MEDLINE were searched for 1974 to 2007. Selection criteria: All randomised trials comparing neonatal ECMO to conventional ventilatory support. Data collection and analysis: The authors independently evaluated the trials for methodological quality and appropriateness for inclusion in the Review (without consideration of their results) and independently extracted the data. Main results: The four trials (three USA and one UK) recruited clinically similar groups of babies. Two trials excluded infants with congenital diaphragmatic hernias. In two trials, transfer for ECMO implied transport over long distances. Two trials had follow-up information. One study included economic evaluation. The three USA trials had very small numbers of patients. Two trials used conventional randomisation with low potential for bias. Two used less usual designs, which led to difficulties in their interpretation. All four trials showed strong benefit of ECMO on mortality (typical RR 0.44; 95% CI 0.31 to 0.61), especially for babies without congenital diaphragmatic hernia (typical RR 0.33, 95% CI 0.21 to 0.53). The UK trial provided follow up information about death or severe disability, and cost-effectiveness, and showed benefit of ECMO at one year (RR 0.56, 95% CI 0.40 to 0.78), four years (RR 0.62, 95% CI 0.45 to 0.86), and seven years (RR 0.64, 95% CI 0.47 to 0.86). Overall nearly half of the children recruited had died or were severely disabled by seven years of age, reflecting the severity of their underlying conditions. A policy of ECMO is as cost-effective as other intensive care technologies in common use. Authors' conclusions: A policy of using ECMO in mature infants with severe but potentially reversible respiratory failure results in significantly improved survival without increased risk of severe disability. The benefit of ECMO for babies with diaphragmatic hernia is unclear. Further studies are needed to consider the optimal timing for introducing ECMO; to identify which infants are most likely to benefit; and to address the implications of neonatal ECMO during later childhood and adult life. Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Systematic review

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Technology assessment for management of congenital diaphragmatic hernia: immediate versus delayed surgery.

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Authors Niramis R
Journal Journal of the Medical Association of Thailand = Chotmaihet thangphaet
Year 2003
Links Pubmed

This article is included in 1 Broad synthesis 25 Broad syntheses (1 reference)

This article includes 25 Primary studies 25 Primary studies (25 references)

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BACKGROUND: Congenital diaphragmatic hernia (CDH) is one of the high-risk diseases in pediatric surgery, especially in neonates with symptom presentation within 6 hours after birth. Opinion regarding the time of surgery has gradually shifted from immediate repair to a policy of stabilization and delayed repair. Whether delayed surgery is beneficial remains controversial. OBJECTIVE: To evaluate the outcomes regarding whether delayed surgical repair improves survival in CDH neonates, who are symptomatic immediately after delivery, is more beneficial than immediate surgery. MATERIAL AND METHOD: Data were obtained by searching MEDLINE (1966-2002) and the Cochrane Database, Issue 2, 2003 using the term "congenital diaphragmatic hernia" and "surgery". Inclusion criteria were randomized controlled trial (RCT), prospective trial (PT), retrospective analysis (RA) and meta-analysis (MA). Information from the literature was analyzed by the computer program of Epi Info Version 3. Statistical significance was reliable at the level of p < 0.05. RESULTS: Twenty-five studies were obtained and RCT/RA was 2/23. Analysis of results of CDH management revealed that pre-operative stabilization and delayed surgery improved the survival rate in 14 of 25 in the literature (p < 0.05), while the remaining 11 articles showed no statistical difference of survival between immediate and delayed surgery (p > 0.05). CONCLUSION: From the evidence-based analysis, the results of CDH management between immediate versus delayed surgery were unclear. From the reviewer's experience at the Queen Sirikit National Institute of Child Health, the strategy of pre-operative stabilization and delayed surgery had better improved survival of CDH than immediate surgery.

Systematic review

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Late versus early surgical correction for congenital diaphragmatic hernia in newborn infants

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Journal Cochrane Database of Systematic Reviews
Year 2002
Links Pubmed DOI

This article is included in 1 Broad synthesis 2 Broad syntheses (1 reference)

This article includes 2 Primary studies 2 Primary studies (2 references)

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Background: Congenital diaphragmatic hernia, although rare (1 per 2-4,000 births), is associated with high mortality and cost. Opinion regarding the timing of surgical repair has gradually shifted from emergent repair to a policy of stabilization using a variety of ventilatory strategies prior to operation. Whether delayed surgery is beneficial remains controversial. Objectives: To summarize the available data regarding whether surgical repair in the first 24 hours after birth rather than later than 24 hours of age improves survival to hospital discharge in infants with congenital diaphragmatic hernia who are symptomatic at or immediately after birth. Search methods: Search of MEDLINE (1966 to Sept 2003), EMBASE (1978 to Oct 2003) and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2003); citations search, and contact with experts in the field to locate other published and unpublished studies. This search was updated in 2009. Selection criteria: Studies were eligible for inclusion if they were randomized or quasi-randomized trials that addressed infants with CDH who were symptomatic at or shortly after birth, comparing early (< 24 hours) vs late (> 24 hours) surgical intervention, and evaluated mortality as the primary outcome. Data collection and analysis: Data were collected regarding study methods and outcomes including mortality, need for ECMO and duration of ventilation, both from the study reports and from personal communication with investigators. Analysis was performed in accordance with the standards of the Cochrane Neonatal Review Group. Main results: Two trials met the pre-specified inclusion criteria for this review. Both were small trials (total n<90) and neither showed any significant difference between groups in mortality. Meta-analysis was not performed because of significant clinical heterogeneity between the trials. Authors' conclusions: There is no clear evidence which favors delayed (when stabilized) as compared with immediate (within 24 hours of birth) timing of surgical repair of congenital diaphragmatic hernia, but a substantial advantage to either one cannot be ruled out. A large, multicenter randomized trial would be needed to answer this question.