ARDSPhase 4PANNCT02902055
Paediatric Ards Neuromuscular Blockade Study
A Phase 4 study testing Neuromuscular Blocking Agents and Isotonic saline in people with ARDS, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe, life-threatening lung injury. Care for paediatric patient is mainly supportive and based on what works in adults and personal experiences, including the use of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- ARDS
- What is being tested?
- Neuromuscular Blocking Agents and Isotonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2019to 1 May 2024
- Phase
- Phase 4
- 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 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent
- Age younger than 5 years
- Need for mechanical ventilation with tidal volume 5 - 8 mL/kg ideal bodyweight and PEEP equal to or greater than 5 cmH2O
- Early moderate - to - severe paediatric acute respiratory distress syndrome originating from any cause, i.e. acute onset of disease, and oxygenation index greater than 12, and one or more (bilateral) infiltrates on chest radiograph, and no evidence of left ventricular failure or fluid overload, and within the first 48 hours of PICU admission
- Sedation defined by Comfort - B scale between 9 - 12
Who cannot join
- No informed consent
- Known allergy or intolerance to rocuronium
- Continuous administration of neuromuscular blockade prior at the time of meeting the criteria for PARDS
- Chronic respiratory failure on home ventilation
- Intracranial hypertension
- Bone marrow transplantation
Show all 12Show fewer
- Immunocompromised patients (congenital or acquired)
- Pre-existing pulmonary hypertension
- Congenital heart disease with left - to - right shunting
- Cyanotic congenital heart disease
- Expected duration of mechanical ventilation less than 48 hours
- Withdrawal of life - sustaining treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Life-threatening Acute Respiratory Failure in Children: to Breathe or Not to Breathe Spontaneously, That's the Question
Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe, life-threatening lung injury. Care for paediatric patient is mainly supportive and based on what works in adults and personal experiences, including the use of mechanical ventilation. However, differences in lung physiology and immunology between (young) children and adults suggests that adaptation of adult practices into paediatrics may not be justified. A study in adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA) improved 90-day survival and increased time off the ventilator without increasing muscle weakness. It is unknown if this is also true for paediatric ARDS
- Conditions
- ARDS
- Being tested
- Neuromuscular Blocking Agents, Isotonic saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Blocking AgentsDrug
Neuromuscular blockae
Isotonic salineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium 1 mg/kg i.v. | Active comparator | Neuromuscular blocking agent Receives: Drug: Neuromuscular Blocking Agents |
| Isotonic saline | Active comparator | Not described Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or allergy, season in which questionnaire was filled out and parental smoking
Measured: 12 months after PICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start1 Dec 2019
- Primary completion1 May 2024
- Study completion1 May 2024
Why it stopped: COVID-19, slow enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Kneyber, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902055
- Sponsor's protocol ID
- PAN.1
- Acronym
- PAN
- Status last verified
- Jan 2024
- First submitted
- 12 Sep 2016
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rudolph MW, Slager S, Burgerhof JGM, van Woensel JBM, Alffenaar JC, Wosten-van Asperen RM, de Hoog M, IJland MM, Kneyber MCJ; SKIC research consortium. Paediatric Acute Respiratory Distress Syndrome Neuromuscular Blockade study (PAN-study): a phase IV randomised controlled trial of early neuromuscular blockade in moderate-to-severe paediatric acute respiratory distress syndrome. Trials. 2022 Jan 31;23(1):96. doi: 10.1186/s13063-021-05927-w.
PubMed 35101098
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life-threatening Acute Respiratory Failure in Children: to Breathe or Not to Breathe Spontaneously, That's the Question
- ClinicalTrials.gov ID
- NCT02902055
- Acronym / sponsor ID
- PAN / PAN.1
- Conditions
- ARDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19, slow enrolment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 15 Sep 2016 (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.
Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe, life-threatening lung injury. Care for paediatric patient is mainly supportive and based on what works in adults and personal experiences, including the use of mechanical ventilation. However, differences in lung physiology and immunology between (young) children and adults suggests that adaptation of adult practices into paediatrics may not be justified. A study in adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA) improved 90-day survival and increased time off the ventilator without increasing muscle weakness. It is unknown if this is also true for paediatric ARDS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium 1 mg/kg i.v. | Active comparator | Drug: Neuromuscular Blocking AgentsNeuromuscular blocking agent |
| Isotonic saline | Active comparator | Drug: Isotonic saline |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Informed consent
- Age younger than 5 years
- Need for mechanical ventilation with tidal volume 5 - 8 mL/kg ideal bodyweight and PEEP equal to or greater than 5 cmH2O
- Early moderate - to - severe paediatric acute respiratory distress syndrome originating from any cause, i.e. acute onset of disease, and oxygenation index greater than 12, and one or more (bilateral) infiltrates on chest radiograph, and no evidence of left ventricular failure or fluid overload, and within the first 48 hours of PICU admission
- Sedation defined by Comfort - B scale between 9 - 12
Key exclusion criteria (12 listed)
- No informed consent
- Known allergy or intolerance to rocuronium
- Continuous administration of neuromuscular blockade prior at the time of meeting the criteria for PARDS
- Chronic respiratory failure on home ventilation
- Intracranial hypertension
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 |
|---|---|---|
| Neuromuscular Blocking AgentsNeuromuscular blockae | Drug | Rocuronium 1 mg/kg i.v. |
| Isotonic salinePlacebo | Drug | Isotonic saline |
Primary outcome
the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or allergy, season in which questionnaire was filled out and parental smoking
Time frame: 12 months after PICU discharge
Results and safety
The study was stopped early (reason given: COVID-19, slow enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 35101098Rudolph MW, Slager S, Burgerhof JGM, van Woensel JBM, Alffenaar JC, Wosten-van Asperen RM, de Hoog M, IJland MM, Kneyber MCJ; SKIC research consortium. Paediatric Acute Respiratory Distress Syndrome Neuromuscular Blockade study (PAN-study): a phase IV randomised controlled trial of early neuromuscular blockade in moderate-to-severe paediatric acute respiratory distress syndrome. Trials. 2022 Jan 31;23(1):96. doi: 10.1186/s13063-021-05927-w.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neuromuscular Blocking Agents and Isotonic saline in people with ARDS, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19, slow enrolment). Results are not available in the source record.
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?
the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or allergy, season in which questionnaire was filled out and parental smoking (time frame: 12 months after PICU discharge). 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 NCT02902055, which also lists 1 linked publication.
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 7 Feb 2025.