Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)

NCT00814099 | Completed DMC

• 3 other identifiers: 611U01HL086622U01HL086649
• Study Type: interventional
• Target: 2,449
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome, Newborn

Keywords

Acute Respiratory Failure; Acute Lung Injury

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)

Secondary Outcomes (11)

• Time to recovery of acute respiratory failure

  Measured from the time of endotracheal intubation to when participants first meet the criteria to be tested for extubation readiness

• Duration of weaning from mechanical ventilation

  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)

• Occurrence of adverse events

  Measured for the duration of the study

• Detection of life-threatening neurological events

  Measured for the duration of the study

• Total sedative exposure

  Measured for the duration of the study

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management.

Behavioral: Usual approach to sedation management

2

EXPERIMENTAL

Participants will receive care at a pediatric ICU that is implementing the team approach to sedation management.

Behavioral: Team approach to sedation management

Interventions

Team approach to sedation management BEHAVIORAL

The team approach to sedation management includes the following: * Team education and consensus on the use of sedatives * Team identification of the patient's trajectory of illness and daily prescription of a sedation goal * A nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines * Team feedback on sedation management performance

2

Usual approach to sedation management BEHAVIORAL

The pediatric ICU will continue its usual approach to sedation management.

1

Eligibility Criteria

• Age: 2 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (31)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

University Medical Center, The University of Arizona

Tucson, Arizona, 85724, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Salter Packard Children's Hospital at Stanford

Palo Alto, California, 94304-0126, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Children's Hospital at University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale-New Haven Children's Hospital

New Haven, Connecticut, 06520-8064, United States

Location

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Holtz Children's Hospital

Miami, Florida, 33136, United States

Location

Florida Hospital for Children

Orlando, Florida, 32803, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614-3363, United States

Location

Advocate Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

University of Maryland Hospital for Children

Baltimore, Maryland, 21201-1595, United States

Location

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

University of Massachusetts Memorial Children's Medical Center

Worcester, Massachusetts, 01655, United States

Location

C. S. Mott Children's Hospital of the University of Michigan

Ann Arbor, Michigan, 48109-0243, United States

Location

Children's Mercy Hospital, Kansas City

Kansas City, Missouri, 84108, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68114, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Location

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Duke Children's Hospital and Health Center

Durham, North Carolina, 27710, United States

Location

Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Monroe Carell, Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232-9075, United States

Location

Medical City Children's Hospital

Dallas, Texas, 75230, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Related Publications (51)

• 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.

  PMID: 30527750 BACKGROUND

• 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.

  PMID: 18838937 BACKGROUND

• 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.

  PMID: 16446601 BACKGROUND

• 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.

  PMID: 39932727 BACKGROUND

• 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.

  PMID: 38923099 BACKGROUND

• 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.

  PMID: 37311208 BACKGROUND

• 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.

  PMID: 37195096 BACKGROUND

• 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.

  PMID: 36728954 BACKGROUND

• 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.

  PMID: 35666188 BACKGROUND

• 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.

  PMID: 35230393 BACKGROUND

• 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.

  PMID: 35219558 BACKGROUND

• 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.

  PMID: 35466341 BACKGROUND

• 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.

  PMID: 35029869 BACKGROUND

• 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.

  PMID: 34495879 BACKGROUND

• 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.

  PMID: 34940862 BACKGROUND

• 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.

  PMID: 34505720 BACKGROUND

• 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.

  PMID: 34883088 BACKGROUND

• 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.

  PMID: 34278308 BACKGROUND

• 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.

  PMID: 34344416 BACKGROUND

• 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.

  PMID: 33590999 BACKGROUND

• 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.

  PMID: 32740188 BACKGROUND

• 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.

  PMID: 32776853 BACKGROUND

• 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.

  PMID: 32725941 BACKGROUND

• 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.

  PMID: 32317601 BACKGROUND

• 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.

  PMID: 32275979 BACKGROUND

• 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.

  PMID: 31034245 BACKGROUND

• 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.

  PMID: 30920410 BACKGROUND

• 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.

  PMID: 30995942 BACKGROUND

• 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.

  PMID: 30672747 BACKGROUND

• 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.

  PMID: 30017814 BACKGROUND

• 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.

  PMID: 30558653 BACKGROUND

• 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.

  PMID: 30095747 BACKGROUND

• 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.

  PMID: 29373797 BACKGROUND

• 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.

  PMID: 29313710 BACKGROUND

• 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.

  PMID: 29567042 BACKGROUND

• 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.

  PMID: 28654569 BACKGROUND

• 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.

  PMID: 28614197 BACKGROUND

• 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.

  PMID: 28410087 BACKGROUND

• 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.

  PMID: 28212163 BACKGROUND

• 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.

  PMID: 27632676 BACKGROUND

• 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.

  PMID: 27513532 BACKGROUND

• 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.

  PMID: 27654816 BACKGROUND

• 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.

  PMID: 26492410 BACKGROUND

• 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.

  PMID: 26509816 BACKGROUND

• 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.

  PMID: 25942731 BACKGROUND

• 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.

  PMID: 23643411 BACKGROUND

• 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.

  PMID: 23817825 BACKGROUND

• 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.

  PMID: 22425823 BACKGROUND

• 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.

  PMID: 25602358 RESULT

• 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.

  PMID: 40471056 DERIVED

• 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.

  PMID: 38038620 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome, Newborn; Lung Diseases; Acute Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Respiratory Distress Syndrome; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Injury

Study Officials

• Martha A.Q. Curley, RN, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• David Wypij, PhD

  Director, Statistics and Data Coordinating Center; Children's Hospital Boston

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 23, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (31)