A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation.

Asphyxia Neonatorum / complications Cross-Over Studies Female Humans Hypoxia-Ischemia, Brain / etiology Infant, Newborn Intubation, Intratracheal / instrumentation Laryngeal Masks Male Midwifery Positive-Pressure Respiration / instrumentation Resuscitation / instrumentation

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
26 11 2020
Historique:
entrez: 30 11 2020
pubmed: 1 12 2020
medline: 19 12 2020
Statut: ppublish

Résumé

Face-mask ventilation is the most common resuscitation method for birth asphyxia. Ventilation with a cuffless laryngeal mask airway (LMA) has potential advantages over face-mask ventilation during neonatal resuscitation in low-income countries, but whether the use of an LMA reduces mortality and morbidity among neonates with asphyxia is unknown. In this phase 3, open-label, superiority trial in Uganda, we randomly assigned neonates who required positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation. All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both. The primary outcome was a composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization. Complete follow-up data were available for 99.2% of the neonates. A primary outcome event occurred in 154 of 563 neonates (27.4%) in the LMA group and 144 of 591 (24.4%) in the face-mask group (adjusted relative risk, 1.16; 95% confidence interval [CI], 0.90 to 1.51; P = 0.26). Death within 7 days occurred in 21.7% of the neonates in the LMA group and 18.4% of those in the face-mask group (adjusted relative risk, 1.21; 95% CI, 0.90 to 1.63), and admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization occurred in 11.2% and 10.1%, respectively (adjusted relative risk, 1.27; 95% CI, 0.84 to 1.93). Findings were materially unchanged in a sensitivity analysis in which neonates with missing data were counted as having had a primary outcome event in the LMA group and as not having had such an event in the face-mask group. The frequency of predefined intervention-related adverse events was similar in the two groups. In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. (Funded by the Research Council of Norway and the Center for Intervention Science in Maternal and Child Health; NeoSupra ClinicalTrials.gov number, NCT03133572.).

Sections du résumé

BACKGROUND
Face-mask ventilation is the most common resuscitation method for birth asphyxia. Ventilation with a cuffless laryngeal mask airway (LMA) has potential advantages over face-mask ventilation during neonatal resuscitation in low-income countries, but whether the use of an LMA reduces mortality and morbidity among neonates with asphyxia is unknown.
METHODS
In this phase 3, open-label, superiority trial in Uganda, we randomly assigned neonates who required positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation. All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both. The primary outcome was a composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization.
RESULTS
Complete follow-up data were available for 99.2% of the neonates. A primary outcome event occurred in 154 of 563 neonates (27.4%) in the LMA group and 144 of 591 (24.4%) in the face-mask group (adjusted relative risk, 1.16; 95% confidence interval [CI], 0.90 to 1.51; P = 0.26). Death within 7 days occurred in 21.7% of the neonates in the LMA group and 18.4% of those in the face-mask group (adjusted relative risk, 1.21; 95% CI, 0.90 to 1.63), and admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization occurred in 11.2% and 10.1%, respectively (adjusted relative risk, 1.27; 95% CI, 0.84 to 1.93). Findings were materially unchanged in a sensitivity analysis in which neonates with missing data were counted as having had a primary outcome event in the LMA group and as not having had such an event in the face-mask group. The frequency of predefined intervention-related adverse events was similar in the two groups.
CONCLUSIONS
In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. (Funded by the Research Council of Norway and the Center for Intervention Science in Maternal and Child Health; NeoSupra ClinicalTrials.gov number, NCT03133572.).

Identifiants

DOI: 10.1056/NEJMoa2005333 PMID: 33252870
pubmed: 33252870
doi: 10.1056/NEJMoa2005333
doi:

Banques de données

ClinicalTrials.gov
['NCT03133572']

Types de publication

Clinical Trial, Phase III Comparative Study Equivalence Trial Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2138-2147

Subventions

Organisme : Norges Forskningsråd
ID : grant 250531
Pays : International
Organisme : United States
ID : grant 223269
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2020 Massachusetts Medical Society.

Auteurs

Nicolas J Pejovic (NJ)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Susanna Myrnerts Höök (S)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.
ORCID: 0000-0001-7560-4077

Josaphat Byamugisha (J)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Tobias Alfvén (T)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Clare Lubulwa (C)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Francesco Cavallin (F)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Jolly Nankunda (J)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Hege Ersdal (H)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Mats Blennow (M)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Daniele Trevisanuto (D)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Thorkild Tylleskär (T)

From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

Recherchemedicale.com › Malformations et maladies congénitales, héréditaires et néonatales › Maladies néonatales › Asphyxie néonatale › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Études croisées › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › États, signes et symptômes pathologiques › Signes et symptômes › Signes et symptômes respiratoires › Hypoxie › Hypoxie cérébrale › Hypoxie-ischémie du cerveau › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Personnes › Tranches d'âge › Nourrisson › Nouveau-né › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Techniques d'investigation › Intubation › Intubation trachéale › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Technologie, industrie et agriculture › Produits manufacturés › Dispositifs de protection › Équipement de protection individuelle › Masques › Masques laryngés › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Professions de santé › Spécialités en soins infirmiers › Profession de sage-femme › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Thérapeutique › Thérapie respiratoire › Ventilation artificielle › Ventilation à pression positive › A Randomized Trial of Laryngeal Mask Airway in...
Recherchemedicale.com › Thérapeutique › Traitement d'urgence › Réanimation › A Randomized Trial of Laryngeal Mask Airway in...