Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study) (RESTORE)
27 de abril de 2026 actualizado por: University of Pennsylvania
Sedation Management in Pediatric Patients With Acute Respiratory Failure
People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator.
Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators.
However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation.
This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
People who are hospitalized for acute respiratory failure are typically supported on mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. Over 90% of infants and children supported on mechanical ventilation receive some form of sedation medication, which helps keep them safe, calm, and comfortable. Unfortunately, the use of sedation medications may prolong the duration of mechanical ventilation, which can lead to an increased risk for pneumonia and other complications.
Recent studies among adults in intensive care units (ICUs) have shown that when doctors and nurses work together as a team to manage the use of sedation medication, patients are taken off mechanical ventilation sooner and with fewer side effects. This team strategy includes the following:
- Training and discussion between doctors and nurses regarding which sedative medications should be used
- Having doctors and nurses jointly identify the patient's progress and a daily sedation medication goal for the patient
- Having nurses use a decision-making tool to help guide changes in a patient's sedative medication dose
- Keeping track of patient care, which allows doctors and nurses to evaluate the effectiveness of how they manage each patient's sedative medication use
This study will examine the use of the sedation management strategy for infants and children in pediatric ICUs who have acute respiratory failure and require mechanical ventilation. The purpose of the study is to evaluate whether this team approach to sedation medication management is more effective than the usual approach at reducing the amount of time children remain on mechanical ventilators. Study researchers will also examine the cost-effectiveness of this approach and associated quality of life factors.
All participants will be enrolled within 24 hours of starting mechanical ventilation and will be monitored until they receive their last dose of sedative medication, hospital discharge, or Day 28 (whichever comes first). During a 3-month baseline period, all participating pediatric ICUs will provide their usual sedation management, and study researchers will review participants' medical records on a daily basis. Each pediatric ICU will then be randomly assigned to either the control group or the team approach group. Pediatric ICUs in the control group will continue to provide usual care for sedation management. Pediatric ICUs in the team approach group will implement the team approach sedation management guidelines. For both groups, pain and sedation levels will be monitored daily, and study researchers will review participants' medical records on a daily basis, too. Six months after hospital discharge, half of the participants and their parents will complete a follow-up survey and take part in a telephone interview to assess quality of life, psychological factors, and health-related resource use.
Tipo de estudio
Intervencionista
Inscripción (Actual)
2449
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Children's Hospital of Alabama
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Arizona
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Tucson, Arizona, Estados Unidos, 85724
- University Medical Center, The University of Arizona
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California
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Oakland, California, Estados Unidos, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Estados Unidos, 94304-0126
- Lucile Salter Packard Children's Hospital at Stanford
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Medical Center
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San Francisco, California, Estados Unidos, 94143
- Children's Hospital at University of California San Francisco Medical Center
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, Estados Unidos, 06520-8064
- Yale-New Haven Children's Hospital
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Delaware
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Wilmington, Delaware, Estados Unidos, 19803
- Nemours/Alfred I. duPont Hospital for Children
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Florida
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Miami, Florida, Estados Unidos, 33136
- Holtz Children's Hospital
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Orlando, Florida, Estados Unidos, 32803
- Florida Hospital for Children
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Illinois
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Chicago, Illinois, Estados Unidos, 60614-3363
- Children's Memorial Hospital, Chicago
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Oak Lawn, Illinois, Estados Unidos, 60453
- Advocate Hope Children's Hospital
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Children's Center
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Baltimore, Maryland, Estados Unidos, 21201-1595
- University of Maryland Hospital for Children
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- University of Massachusetts Memorial Children's Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0243
- C. S. Mott Children's Hospital of the University of Michigan
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Missouri
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Kansas City, Missouri, Estados Unidos, 84108
- Children's Mercy Hospital, Kansas City
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St Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- University of Nebraska Medical Center
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0001
- Dartmouth-Hitchcock Medical Center
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New York
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New Hyde Park, New York, Estados Unidos, 11040
- Cohen Children's Medical Center of New York
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The Bronx, New York, Estados Unidos, 10467
- The Children's Hospital at Montefiore
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Children's Hospital and Health Center
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Doernbecher Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232-9075
- Monroe Carell, Jr. Children's Hospital at Vanderbilt
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Children's Medical Center Dallas
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Dallas, Texas, Estados Unidos, 75230
- Medical City Children's Hospital
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113
- Primary Children's Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
2 semanas a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- At least 2 weeks of age (and at least 42 weeks post-menstrual age) and less than 18 years of age
- Intubated and mechanically ventilated for acute lung disease
Exclusion Criteria:
- Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- History of single ventricle at any stage of repair
- Congenital diaphragmatic hernia or paralysis
- Primary pulmonary hypertension
- Critical airway or anatomical obstruction of the lower airway
- Ventilator dependent upon pediatric ICU admission
- Neuromuscular respiratory failure
- Spinal cord injury above the lumbar region
- Pain managed by patient-controlled analgesia or epidural catheter
- Patient transferred from an outside ICU where sedatives had already been administered for more than 24 hours
- Family or medical team has decided not to provide full support
- Enrolled in any other critical care interventional clinical trial concurrently or in the 30 days before study entry
- Known allergy to any of the study medications
- Pregnancy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 1
Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.
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The pediatric ICU will continue its usual approach to sedation management.
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Experimental: 2
Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.
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The team approach to sedation management includes the following:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Duration of mechanical ventilation
Periodo de tiempo: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)
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Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Time to recovery of acute respiratory failure
Periodo de tiempo: Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness
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Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness
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Duration of weaning from mechanical ventilation
Periodo de tiempo: Measured from the time participants meet the criteria to be tested for extubation readiness until the time of the first successful extubation (defined as extubation for more than 24 hours)
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Measured from the time participants meet the criteria to be tested for extubation readiness until the time of the first successful extubation (defined as extubation for more than 24 hours)
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Occurrence of adverse events
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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Detection of life-threatening neurological events
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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Total sedative exposure
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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Occurrence of iatrogenic withdrawal symptoms
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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Pediatric ICU and hospital length of stay
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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Hospital costs
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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Study implementation costs and cost-effectiveness
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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In-hospital mortality
Periodo de tiempo: Measured for the duration of the study
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Measured for the duration of the study
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Post-discharge quality of life and emotional health
Periodo de tiempo: Measured 6 months after pediatric ICU discharge
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Measured 6 months after pediatric ICU discharge
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Martha A.Q. Curley, RN, PhD, University of Pennsylvania
- Director de estudio: David Wypij, PhD, Director, Statistics and Data Coordinating Center; Children's Hospital Boston
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399.
- Curley MA, Harris SK, Fraser KA, Johnson RA, Arnold JH. State Behavioral Scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation. Pediatr Crit Care Med. 2006 Mar;7(2):107-14. doi: 10.1097/01.PCC.0000200955.40962.38.
- Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008 Nov;9(6):573-80. doi: 10.1097/PCC.0b013e31818c8328.
- Grant MJ, Balas MC, Curley MA; RESTORE Investigative Team. Defining sedation-related adverse events in the pediatric intensive care unit. Heart Lung. 2013 May-Jun;42(3):171-6. doi: 10.1016/j.hrtlng.2013.02.004.
- Best KM, Asaro LA, Curley MAQ; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. Sedation Management for Critically Ill Children with Pre-Existing Cognitive Impairment. J Pediatr. 2019 Mar;206:204-211.e1. doi: 10.1016/j.jpeds.2018.10.042. Epub 2018 Dec 5.
- Ward SL, Dawkins-Henry OS, Asaro LA, Wypij D, Curley MAQ; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. Association of Obesity With Sedative Dosing, Sedative Response, and Clinical Outcomes in Mechanically Ventilated Critically Ill Children. Crit Care Explor. 2025 Feb 10;7(2):e1214. doi: 10.1097/CCE.0000000000001214. eCollection 2025 Feb 1.
- Sorce LR, Asaro LA, Curley MAQ; RESTORE Study Investigators. Infant feeding and criticality in children. Nurs Crit Care. 2025 Mar;30(2):e13103. doi: 10.1111/nicc.13103. Epub 2024 Jun 26.
- Flori HR, Zhang M, Xie J, Yang G, Sapru A, Calfee CS, Delucchi KL, Sinha P, Curley MAQ, Dahmer MK. Subphenotypes Assigned to Pediatric Acute Respiratory Failure Patients Show Differing Outcomes. Am J Respir Crit Care Med. 2023 Aug 1;208(3):331-333. doi: 10.1164/rccm.202301-0070LE. No abstract available.
- Ardila SM, Weeks HM, Dahmer MK, Kaciroti N, Quasney M, Sapru A, Curley MAQ, Flori HR; Biomarkers in Children with Acute Lung Injury (BALI) and Randomized Evaluation for Sedation Titration for Respiratory Failure (RESTORE) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. A Targeted Analysis of Serial Cytokine Measures and Nonpulmonary Organ System Failure in Children With Acute Respiratory Failure: Individual Measures and Trajectories Over Time. Pediatr Crit Care Med. 2023 Sep 1;24(9):727-737. doi: 10.1097/PCC.0000000000003286. Epub 2023 May 17.
- Olszewski AE, Dervan LA, Smith MB, Asaro LA, Wypij D, Curley MAQ, Watson RS. Risk Factors for Positive Post-Traumatic Stress Disorder Screening and Associated Outcomes in Children Surviving Acute Respiratory Failure: A Secondary Analysis of the Randomized Evaluation of Sedation Titration for Respiratory Failure Clinical Trial. Pediatr Crit Care Med. 2023 Mar 1;24(3):222-232. doi: 10.1097/PCC.0000000000003150. Epub 2022 Dec 23.
- Broden EG, Hinds PS, Werner-Lin AV, Curley MAQ; for the RESTORE Study Investigators. "I Didn't Want My Baby to Pass, But I Didn't Want Him Suffering Either": Comparing Bereaved Parents' Narratives With Nursing End-of-Life Assessments in the Pediatric Intensive Care Unit. J Hosp Palliat Nurs. 2022 Oct 1;24(5):271-280. doi: 10.1097/NJH.0000000000000884. Epub 2022 Jun 6.
- Watson RS, Beers SR, Asaro LA, Burns C, Koh MJ, Perry MA, Angus DC, Wypij D, Curley MAQ; RESTORE-Cognition Investigators. Association of Acute Respiratory Failure in Early Childhood With Long-term Neurocognitive Outcomes. JAMA. 2022 Mar 1;327(9):836-845. doi: 10.1001/jama.2022.1480.
- Broden EG, Werner-Lin A, Curley MAQ, Hinds PS. Shifting and intersecting needs: Parents' experiences during and following the withdrawal of life sustaining treatments in the paediatric intensive care unit. Intensive Crit Care Nurs. 2022 Jun;70:103216. doi: 10.1016/j.iccn.2022.103216. Epub 2022 Feb 24.
- Broden EG, Hinds PS, Werner-Lin A, Quinn R, Asaro LA, Curley MAQ. Nursing Care at End of Life in Pediatric Intensive Care Unit Patients Requiring Mechanical Ventilation. Am J Crit Care. 2022 May 1;31(3):230-239. doi: 10.4037/ajcc2022294.
- Rudolph MW, Kneyber MCJ, Asaro LA, Cheifetz IM, Wypij D, Curley MAQ; for the Randomized Evaluation of Sedation Titration for Respiratory Failure ( RESTORE ) Study Investigators. Early Neuromuscular Blockade in Moderate-to-Severe Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2022 May 1;50(5):e445-e457. doi: 10.1097/CCM.0000000000005426. Epub 2022 Jan 6.
- Kachmar AG, Watson RS, Wypij D, Perry MA, Curley MAQ; for the Randomized Evaluation of Sedation Titration for Respiratory Failure ( RESTORE ) Investigative Team. Association of Socioeconomic Status With Postdischarge Pediatric Resource Use and Quality of Life. Crit Care Med. 2022 Feb 1;50(2):e117-e128. doi: 10.1097/CCM.0000000000005261.
- Carlton EF, Donnelly JP, Prescott HC, Asaro LA, Barbaro RP, Watson RS, Curley MAQ; RESTORE Study Investigators. School and Work Absences After Critical Care Hospitalization for Pediatric Acute Respiratory Failure: A Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2140732. doi: 10.1001/jamanetworkopen.2021.40732.
- Kachmar AG, Wypij D, Perry MA, Curley MAQ; RESTORE Study Investigators. Income-driven socioeconomic status and presenting illness severity in children with acute respiratory failure. Res Nurs Health. 2021 Dec;44(6):920-930. doi: 10.1002/nur.22182. Epub 2021 Sep 10.
- Dahmer MK, Yang G, Zhang M, Quasney MW, Sapru A, Weeks HM, Sinha P, Curley MAQ, Delucchi KL, Calfee CS, Flori H; RESTORE and BALI study investigators; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Identification of phenotypes in paediatric patients with acute respiratory distress syndrome: a latent class analysis. Lancet Respir Med. 2022 Mar;10(3):289-297. doi: 10.1016/S2213-2600(21)00382-9. Epub 2021 Dec 6.
- Carlton EF, Weeks HM, Dahmer MK, Quasney MW, Sapru A, Curley MAQ, Flori HR. Inflammatory Biomarkers Are Associated With a Decline in Functional Status at Discharge in Children With Acute Respiratory Failure: An Exploratory Analysis. Crit Care Explor. 2021 Jul 13;3(7):e0467. doi: 10.1097/CCE.0000000000000467. eCollection 2021 Jul.
- Monteiro ACC, Flori H, Dahmer MK, Sim MS, Quasney MW, Curley MAQ, Matthay MA, Sapru A; BALI Study Investigators of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Thrombomodulin is associated with increased mortality and organ failure in mechanically ventilated children with acute respiratory failure: biomarker analysis from a multicenter randomized controlled trial. Crit Care. 2021 Aug 3;25(1):271. doi: 10.1186/s13054-021-03626-1.
- Kopp W, Gedeit RG, Asaro LA, McLaughlin GE, Wypij D, Curley MAQ; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. The Impact of Preintubation Noninvasive Ventilation on Outcomes in Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2021 May 1;49(5):816-827. doi: 10.1097/CCM.0000000000004819.
- Lincoln PA, Whelan K, Hartwell LP, Gauvreau K, Dodsen BL, LaRovere JM, Thiagarajan RR, Hickey PA, Curley MAQ. Nurse-Implemented Goal-Directed Strategy to Improve Pain and Sedation Management in a Pediatric Cardiac ICU. Pediatr Crit Care Med. 2020 Dec;21(12):1064-1070. doi: 10.1097/PCC.0000000000002505.
- Natale JE, Asaro LA, Joseph JG, Ulysse C, Ascenzi J, Bowens C, Wypij D, Curley MAQ; RESTORE Study Investigators. Association of Race and Ethnicity with Sedation Management in Pediatric Intensive Care. Ann Am Thorac Soc. 2021 Jan;18(1):93-102. doi: 10.1513/AnnalsATS.201912-872OC.
- Ward SL, Dahmer MK, Weeks HM, Sapru A, Quasney MW, Curley MAQ, Liu KD, Matthay MA, Flori HR. Association of patient weight status with plasma surfactant protein D, a biomarker of alveolar epithelial injury, in children with acute respiratory failure. Pediatr Pulmonol. 2020 Oct;55(10):2730-2736. doi: 10.1002/ppul.24990. Epub 2020 Aug 7.
- Kohne JG, Dahmer MK, Weeks HM, Kaciroti N, Quasney MW, Sapru A, Curley MAQ, Matthay M, Flori H. Impact of Bilateral Infiltrates on Inflammatory Biomarker Levels and Clinical Outcomes of Children With Oxygenation Defect. Crit Care Med. 2020 Jun;48(6):e498-e504. doi: 10.1097/CCM.0000000000004316.
- Dahmer MK, Flori H, Sapru A, Kohne J, Weeks HM, Curley MAQ, Matthay MA, Quasney MW; BALI and RESTORE Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Surfactant Protein D Is Associated With Severe Pediatric ARDS, Prolonged Ventilation, and Death in Children With Acute Respiratory Failure. Chest. 2020 Sep;158(3):1027-1035. doi: 10.1016/j.chest.2020.03.041. Epub 2020 Apr 8.
- Watson RS, Asaro LA, Hutchins L, Bysani GK, Killien EY, Angus DC, Wypij D, Curley MAQ. Risk Factors for Functional Decline and Impaired Quality of Life after Pediatric Respiratory Failure. Am J Respir Crit Care Med. 2019 Oct 1;200(7):900-909. doi: 10.1164/rccm.201810-1881OC.
- Zuppa AF, Benitez GR, Zane NR, Curley MAQ, Bradfield J, Hakonarson H, Gastonguay MS, Moorthy G, Prodell J, Gastonguay MR. Morphine Dose Optimization in Critically Ill Pediatric Patients With Acute Respiratory Failure: A Population Pharmacokinetic-Pharmacogenomic Study. Crit Care Med. 2019 Jun;47(6):e485-e494. doi: 10.1097/CCM.0000000000003741.
- Flori H, Sapru A, Quasney MW, Gildengorin G, Curley MAQ, Matthay MA, Dahmer MK; BALI and RESTORE Study Investigators, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. A prospective investigation of interleukin-8 levels in pediatric acute respiratory failure and acute respiratory distress syndrome. Crit Care. 2019 Apr 17;23(1):128. doi: 10.1186/s13054-019-2342-8.
- Zuppa AF, Conrado DJ, Zane NR, Curley MAQ, Bradfield J, Hakonarson H, Gastonguay MS, Moorthy G, Prodell J, Gastonguay MR. Midazolam Dose Optimization in Critically Ill Pediatric Patients With Acute Respiratory Failure: A Population Pharmacokinetic-Pharmacogenomic Study. Crit Care Med. 2019 Apr;47(4):e301-e309. doi: 10.1097/CCM.0000000000003638.
- Curley MAQ, Watson RS, Cassidy AM, Burns C, Delinger RL, Angus DC, Asaro LA, Wypij D, Beers SR; RESTORE-cognition Study Investigators. Design and rationale of the "Sedation strategy and cognitive outcome after critical illness in early childhood" study. Contemp Clin Trials. 2018 Sep;72:8-15. doi: 10.1016/j.cct.2018.07.004. Epub 2018 Jul 11.
- Curley MAQ, Gedeit RG, Dodson BL, Amling JK, Soetenga DJ, Corriveau CO, Asario LA, Wypij D; RESTORE Investigative Team. Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial. Trials. 2018 Dec 17;19(1):687. doi: 10.1186/s13063-018-3075-8.
- Dahmer MK, Quasney MW, Sapru A, Gildengorin G, Curley MAQ, Matthay MA, Flori H; BALI and RESTORE Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Interleukin-1 Receptor Antagonist Is Associated With Pediatric Acute Respiratory Distress Syndrome and Worse Outcomes in Children With Acute Respiratory Failure. Pediatr Crit Care Med. 2018 Oct;19(10):930-938. doi: 10.1097/PCC.0000000000001680.
- Barbaro RP, Xu Y, Borasino S, Truemper EJ, Watson RS, Thiagarajan RR, Wypij D, Curley MAQ; RESTORE Study Investigators *. Does Extracorporeal Membrane Oxygenation Improve Survival in Pediatric Acute Respiratory Failure? Am J Respir Crit Care Med. 2018 May 1;197(9):1177-1186. doi: 10.1164/rccm.201709-1893OC.
- Watson RS, Asaro LA, Hertzog JH, Sorce LR, Kachmar AG, Dervan LA, Angus DC, Wypij D, Curley MAQ; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Long-Term Outcomes after Protocolized Sedation versus Usual Care in Ventilated Pediatric Patients. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1457-1467. doi: 10.1164/rccm.201708-1768OC.
- Lebet RM, Asaro LA, Zuppa AF, Curley MAQ. Face and content validity of variables associated with the difficult-to-sedate child in the paediatric intensive care unit: A survey of paediatric critical care clinicians. Aust Crit Care. 2018 May;31(3):167-173. doi: 10.1016/j.aucc.2017.12.091. Epub 2018 Mar 19.
- Lebet R, Hayakawa J, Chamblee TB, Tala JA, Singh N, Wypij D, Curley MAQ. Maintaining Interrater Agreement of Core Assessment Instruments in a Multisite Randomized Controlled Clinical Trial: The Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Trial. Nurs Res. 2017 Jul/Aug;66(4):323-329. doi: 10.1097/NNR.0000000000000224.
- Schneider JB, Sweberg T, Asaro LA, Kirby A, Wypij D, Thiagarajan RR, Curley MAQ; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. Sedation Management in Children Supported on Extracorporeal Membrane Oxygenation for Acute Respiratory Failure. Crit Care Med. 2017 Oct;45(10):e1001-e1010. doi: 10.1097/CCM.0000000000002540.
- Natale JE, Lebet R, Joseph JG, Ulysse C, Ascenzi J, Wypij D, Curley MAQ; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial. J Pediatr. 2017 May;184:204-208.e1. doi: 10.1016/j.jpeds.2017.02.006. Epub 2017 Mar 2.
- Weiss SL, Asaro LA, Flori HR, Allen GL, Wypij D, Curley MA; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. Multiple Organ Dysfunction in Children Mechanically Ventilated for Acute Respiratory Failure. Pediatr Crit Care Med. 2017 Apr;18(4):319-329. doi: 10.1097/PCC.0000000000001091.
- Faustino EV, Gedeit R, Schwarz AJ, Asaro LA, Wypij D, Curley MA; Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators. Accuracy of an Extubation Readiness Test in Predicting Successful Extubation in Children With Acute Respiratory Failure From Lower Respiratory Tract Disease. Crit Care Med. 2017 Jan;45(1):94-102. doi: 10.1097/CCM.0000000000002024.
- Best KM, Wypij D, Asaro LA, Curley MA; Randomized Evaluation of Sedation Titration For Respiratory Failure Study Investigators. Patient, Process, and System Predictors of Iatrogenic Withdrawal Syndrome in Critically Ill Children. Crit Care Med. 2017 Jan;45(1):e7-e15. doi: 10.1097/CCM.0000000000001953.
- Grant MJ, Schneider JB, Asaro LA, Dodson BL, Hall BA, Simone SL, Cowl AS, Munkwitz MM, Wypij D, Curley MA; Randomized Evaluation of Sedation Titration for Respiratory Failure Study Investigators. Dexmedetomidine Use in Critically Ill Children With Acute Respiratory Failure. Pediatr Crit Care Med. 2016 Dec;17(12):1131-1141. doi: 10.1097/PCC.0000000000000941.
- Bateman ST, Borasino S, Asaro LA, Cheifetz IM, Diane S, Wypij D, Curley MA; RESTORE Study Investigators. Early High-Frequency Oscillatory Ventilation in Pediatric Acute Respiratory Failure. A Propensity Score Analysis. Am J Respir Crit Care Med. 2016 Mar 1;193(5):495-503. doi: 10.1164/rccm.201507-1381OC.
- Best KM, Asaro LA, Franck LS, Wypij D, Curley MA; Randomized Evaluation of Sedation Titration for Respiratory Failure Baseline Study Investigators. Patterns of Sedation Weaning in Critically Ill Children Recovering From Acute Respiratory Failure. Pediatr Crit Care Med. 2016 Jan;17(1):19-29. doi: 10.1097/PCC.0000000000000572.
- Curley MA, Wypij D, Matthay MA; RESTORE Study Investigators. Sedation protocol for critically ill pediatric patients--reply. JAMA. 2015 May 5;313(17):1754-5. doi: 10.1001/jama.2015.3462. No abstract available.
- Lebet R, Fineman LD, Faustino EV, Curley MA. Asking for parents' permission to enroll their child into a clinical trial: best practices. Am J Crit Care. 2013 Jul;22(4):351-6. doi: 10.4037/ajcc2013352. No abstract available.
- Grant MJ, Scoppettuolo LA, Wypij D, Curley MA; RESTORE Investigative Team. Prospective evaluation of sedation-related adverse events in pediatric patients ventilated for acute respiratory failure. Crit Care Med. 2012 Apr;40(4):1317-23. doi: 10.1097/CCM.0b013e31823c8ae3.
- Tasker RC. Respiratory Support for Bronchiolitis Management in the PICU: What We Now Know and What We Want to Know. Pediatr Crit Care Med. 2025 Jun 1;26(6):e827-e831. doi: 10.1097/PCC.0000000000003765. Epub 2025 Jun 5. No abstract available.
- Fischer M, Ngendahimana DK, Watson RS, Schwarz AJ, Shein SL. Cognitive, Functional, and Quality of Life Outcomes 6 Months After Mechanical Ventilation for Bronchiolitis: A Secondary Analysis of Data From the Randomized Evaluation of Sedation Titration for Respiratory Failure Trial ( RESTORE ). Pediatr Crit Care Med. 2024 Mar 1;25(3):e129-e139. doi: 10.1097/PCC.0000000000003405. Epub 2023 Dec 1.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2009
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
19 de diciembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
19 de diciembre de 2008
Publicado por primera vez (Estimado)
23 de diciembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Infantil, Prematuro, Enfermedades
- Infantil, Recién Nacido, Enfermedades
- Lesión pulmonar
- Síndrome de Dificultad Respiratoria
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades pulmonares
- Síndrome de Dificultad Respiratoria, Recién Nacido
- Insuficiencia respiratoria
- Lesión pulmonar aguda
Otros números de identificación del estudio
- 611
- U01HL086622 (Subvención/contrato del NIH de EE. UU.)
- U01HL086649 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .