Respiratory InsufficiencyRESTORENCT00814099
Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)
A study testing Team approach to sedation management and Usual approach to sedation management in people with Respiratory Insufficiency and Respiratory Distress Syndrome, Newborn, run by University of Pennsylvania at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 18 years
- Conditions the study is for
- Respiratory Insufficiency, Respiratory Distress Syndrome, Newborn, Lung Diseases
- What is being tested?
- Team approach to sedation management and Usual approach to sedation management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,449 participants
- Where
- 31 sitesUnited States
- Study dates
- Jan 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
C. S. Mott Children's Hospital of the University of Michigan
Ann Arbor, Michigan, 48109-0243
University of Maryland Hospital for Children
Baltimore, Maryland, 21201-1595
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614-3363
Medical City Children's Hospital
Dallas, Texas, 75230
Children's Medical Center Dallas
Dallas, Texas, 75235
Duke Children's Hospital and Health Center
Durham, North Carolina, 27710
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Children's Mercy Hospital, Kansas City
Kansas City, Missouri, 84108
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Holtz Children's Hospital
Miami, Florida, 33136
Monroe Carell, Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232-9075
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06520-8064
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Children's Hospital of Orange County
Orange, California, 92868
Florida Hospital for Children
Orlando, Florida, 32803
Lucile Salter Packard Children's Hospital at Stanford
Palo Alto, California, 94304-0126
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Doernbecher Children's Hospital
Portland, Oregon, 97239
University of California Davis Medical Center
Sacramento, California, 95817
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Children's Hospital at University of California San Francisco Medical Center
San Francisco, California, 94143
St. Louis Children's Hospital
St Louis, Missouri, 63110
The Children's Hospital at Montefiore
The Bronx, New York, 10467
University Medical Center, The University of Arizona
Tucson, Arizona, 85724
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
University of Massachusetts Memorial Children's Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Team approach to sedation management, Usual approach to sedation management
- Keywords
- Acute Respiratory Failure, Acute Lung Injury
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome, Newborn, Lung Diseases, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team approach to sedation managementBehavioural
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
Usual approach to sedation managementBehavioural
The pediatric ICU will continue its usual approach to sedation management.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive care at a pediatric ICU that is continuing the usual approach to sedation management. Receives: 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. Receives: Behavioral: Team approach to sedation management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Measured: 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: 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: 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: Measured for the duration of the study
Detection of life-threatening neurological events
Measured: Measured for the duration of the study
Total sedative exposure
Measured: Measured for the duration of the study
Occurrence of iatrogenic withdrawal symptoms
Measured: Measured for the duration of the study
Pediatric ICU and hospital length of stay
Measured: Measured for the duration of the study
Hospital costs
Measured: Measured for the duration of the study
Study implementation costs and cost-effectiveness
Measured: Measured for the duration of the study
In-hospital mortality
Measured: Measured for the duration of the study
Post-discharge quality of life and emotional health
Measured: Measured 6 months after pediatric ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,449 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Martha A.Q. Curley, RN, PhD, Principal investigator, University of PennsylvaniaDavid Wypij, PhD, Study director, Director, Statistics and Data Coordinating Center; Children's Hospital Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814099
- Sponsor's protocol ID
- 611
- Other IDs
- U01HL086622, U01HL086649
- Acronym
- RESTORE
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2008
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30527750Franck 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.
PubMed 18838937Curley 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.
PubMed 16446601Ward 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.
PubMed 39932727Sorce 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.
PubMed 38923099Flori 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.
PubMed 37311208Ardila 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.
PubMed 37195096Olszewski 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.
PubMed 36728954Broden 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.
PubMed 35666188Watson 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.
PubMed 35230393Broden 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.
PubMed 35219558Broden 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.
PubMed 35466341Rudolph 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.
PubMed 35029869Kachmar 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.
PubMed 34495879Carlton 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.
PubMed 34940862
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Management in Pediatric Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT00814099
- Acronym / sponsor ID
- RESTORE / 611
- Keywords
- Acute Respiratory Failure, Acute Lung Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,449 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Usual approach to sedation managementParticipants will receive care at a pediatric ICU that is continuing the usual approach to sedation management. |
| 2 | Experimental | Behavioral: Team approach to sedation managementParticipants will receive care at a pediatric ICU that is implementing the team approach to sedation management. |
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team approach to sedation managementThe 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 | Behavioural | 2 |
| Usual approach to sedation managementThe pediatric ICU will continue its usual approach to sedation management. | Behavioural | 1 |
Primary outcome
Duration of mechanical ventilation
Time frame: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)
11 secondary outcomes
Time to recovery of acute respiratory failure
Time frame: 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
Time frame: 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
Time frame: Measured for the duration of the study
Detection of life-threatening neurological events
Time frame: Measured for the duration of the study
Total sedative exposure
Time frame: Measured for the duration of the study
Occurrence of iatrogenic withdrawal symptoms
Time frame: Measured for the duration of the study
Pediatric ICU and hospital length of stay
Time frame: Measured for the duration of the study
Hospital costs
Time frame: Measured for the duration of the study
Study implementation costs and cost-effectiveness
Time frame: Measured for the duration of the study
In-hospital mortality
Time frame: Measured for the duration of the study
Post-discharge quality of life and emotional health
Time frame: Measured 6 months after pediatric ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 30527750Best 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.
- Background: PubMed 18838937Franck 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.
- Background: PubMed 16446601Curley 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.
- Background: PubMed 39932727Ward 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.
- Background: PubMed 38923099Sorce 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.
- Background: PubMed 37311208Flori 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.
- Background: PubMed 37195096Ardila 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.
- Background: PubMed 36728954Olszewski 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.
- Background: PubMed 35666188Broden 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.
- Background: PubMed 35230393Watson 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.
- Background: PubMed 35219558Broden 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.
- Background: PubMed 35466341Broden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha A.Q. Curley, RN, PhD principal investigator
University of Pennsylvania
David Wypij, PhD study director
Director, Statistics and Data Coordinating Center; Children's Hospital Boston
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team approach to sedation management and Usual approach to sedation management in people with Respiratory Insufficiency and Respiratory Distress Syndrome, Newborn, run by University of Pennsylvania at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: Measured from the time of endotracheal intubation to the end of scheduled sedation therapy, hospital discharge, or Day 28 (whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00814099, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.