Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis
<p>Abstract</p> <p>Background</p> <p>Preterm infants requiring assisted ventilation are at significant risk of both pulmonary and cerebral injury. Inhaled Nitric Oxide, an effective therapy for pulmonary hypertension and hypoxic respiratory failure in the full term infa...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2010-03-01
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| Series: | BMC Pediatrics |
| Online Access: | http://www.biomedcentral.com/1471-2431/10/15 |
| _version_ | 1819141236087324672 |
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| author | Schreiber Michael D Rich Wade Kinsella John P Mercier Jean-Christophe Hibbs Anna Hascoet Jean-Michel Field David Elbourne Diana Dani Carlo Cutter Gary Ballard Roberta A Askie Lisa M Srisuparp Pimol Subhedar Nim V Van Meurs Krisa P Voysey Merryn Barrington Keith Ehrenkranz Richard A Finer Neil |
| author_facet | Schreiber Michael D Rich Wade Kinsella John P Mercier Jean-Christophe Hibbs Anna Hascoet Jean-Michel Field David Elbourne Diana Dani Carlo Cutter Gary Ballard Roberta A Askie Lisa M Srisuparp Pimol Subhedar Nim V Van Meurs Krisa P Voysey Merryn Barrington Keith Ehrenkranz Richard A Finer Neil |
| author_sort | Schreiber Michael D |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Preterm infants requiring assisted ventilation are at significant risk of both pulmonary and cerebral injury. Inhaled Nitric Oxide, an effective therapy for pulmonary hypertension and hypoxic respiratory failure in the full term infant, has also been studied in preterm infants. The most recent Cochrane review of preterm infants includes 11 studies and 3,370 participants. The results show a statistically significant reduction in the combined outcome of death or chronic lung disease (CLD) in two studies with routine use of iNO in intubated preterm infants. However, uncertainty remains as a larger study (Kinsella 2006) showed no significant benefit for iNO for this combined outcome. Also, trials that included very ill infants do not demonstrate significant benefit. One trial of iNO treatment at a later postnatal age reported a decrease in the incidence of CLD. The aim of this individual patient meta-analysis is to confirm or refute these potentially conflicting results and to determine the extent to which patient or treatment characteristics may explain the results and/or may predict benefit from inhaled Nitric Oxide in preterm infants.</p> <p>Methods/Design</p> <p>The Meta-Analysis of Preterm Patients on inhaled Nitric Oxide <b>(MAPPiNO)</b> Collaboration will perform an individual patient data meta-analysis to answer these important clinical questions. Studies will be included if preterm infants receiving assisted ventilation are randomized to receive inhaled Nitric Oxide or to a control group. The individual patient data provided by the Collaborators will be analyzed on an intention-to-treat basis where possible. Binary outcomes will be analyzed using log-binomial regression models and continuous outcomes will be analyzed using linear fixed effects models. Adjustments for trial differences will be made by including the trial variable in the model specification.</p> <p>Discussion</p> <p>Thirteen (13) trials, with a total of 3567 infants are eligible for inclusion in the MAPPiNO systematic review. To date 11 trials (n = 3298, 92% of available patients) have agreed to participate. Funding was successfully granted from Ikaria Inc as an unrestricted grant. A collaborative group was formed in 2006 with data collection commencing in 2007. It is anticipated that data analysis will commence in late 2009 with results being publicly available in 2010.</p> |
| first_indexed | 2024-12-22T11:51:14Z |
| format | Article |
| id | doaj.art-33856148610b448a999647ea00438e08 |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-22T11:51:14Z |
| publishDate | 2010-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-33856148610b448a999647ea00438e082022-12-21T18:26:58ZengBMCBMC Pediatrics1471-24312010-03-011011510.1186/1471-2431-10-15Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysisSchreiber Michael DRich WadeKinsella John PMercier Jean-ChristopheHibbs AnnaHascoet Jean-MichelField DavidElbourne DianaDani CarloCutter GaryBallard Roberta AAskie Lisa MSrisuparp PimolSubhedar Nim VVan Meurs Krisa PVoysey MerrynBarrington KeithEhrenkranz Richard AFiner Neil<p>Abstract</p> <p>Background</p> <p>Preterm infants requiring assisted ventilation are at significant risk of both pulmonary and cerebral injury. Inhaled Nitric Oxide, an effective therapy for pulmonary hypertension and hypoxic respiratory failure in the full term infant, has also been studied in preterm infants. The most recent Cochrane review of preterm infants includes 11 studies and 3,370 participants. The results show a statistically significant reduction in the combined outcome of death or chronic lung disease (CLD) in two studies with routine use of iNO in intubated preterm infants. However, uncertainty remains as a larger study (Kinsella 2006) showed no significant benefit for iNO for this combined outcome. Also, trials that included very ill infants do not demonstrate significant benefit. One trial of iNO treatment at a later postnatal age reported a decrease in the incidence of CLD. The aim of this individual patient meta-analysis is to confirm or refute these potentially conflicting results and to determine the extent to which patient or treatment characteristics may explain the results and/or may predict benefit from inhaled Nitric Oxide in preterm infants.</p> <p>Methods/Design</p> <p>The Meta-Analysis of Preterm Patients on inhaled Nitric Oxide <b>(MAPPiNO)</b> Collaboration will perform an individual patient data meta-analysis to answer these important clinical questions. Studies will be included if preterm infants receiving assisted ventilation are randomized to receive inhaled Nitric Oxide or to a control group. The individual patient data provided by the Collaborators will be analyzed on an intention-to-treat basis where possible. Binary outcomes will be analyzed using log-binomial regression models and continuous outcomes will be analyzed using linear fixed effects models. Adjustments for trial differences will be made by including the trial variable in the model specification.</p> <p>Discussion</p> <p>Thirteen (13) trials, with a total of 3567 infants are eligible for inclusion in the MAPPiNO systematic review. To date 11 trials (n = 3298, 92% of available patients) have agreed to participate. Funding was successfully granted from Ikaria Inc as an unrestricted grant. A collaborative group was formed in 2006 with data collection commencing in 2007. It is anticipated that data analysis will commence in late 2009 with results being publicly available in 2010.</p>http://www.biomedcentral.com/1471-2431/10/15 |
| spellingShingle | Schreiber Michael D Rich Wade Kinsella John P Mercier Jean-Christophe Hibbs Anna Hascoet Jean-Michel Field David Elbourne Diana Dani Carlo Cutter Gary Ballard Roberta A Askie Lisa M Srisuparp Pimol Subhedar Nim V Van Meurs Krisa P Voysey Merryn Barrington Keith Ehrenkranz Richard A Finer Neil Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis BMC Pediatrics |
| title | Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis |
| title_full | Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis |
| title_fullStr | Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis |
| title_full_unstemmed | Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis |
| title_short | Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis |
| title_sort | inhaled nitric oxide in preterm infants a systematic review and individual patient data meta analysis |
| url | http://www.biomedcentral.com/1471-2431/10/15 |
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