Meconium Aspiration SyndromeMASTIMENCT04076189
Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid
A study testing Endotracheal suctioning and No endotracheal suctioning in people with Meconium Aspiration Syndrome and Infant, Newborn, Disease, run by University Hospital Padova at 2 sites in Italy.
Trial summary
Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meconium Aspiration Syndrome, Infant, Newborn, Disease, Neonatal Resuscitation
- What is being tested?
- Endotracheal suctioning and No endotracheal suctioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Sep 2019to 24 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Level III NICU consultants, residents, and fellows trained in advanced airway management will be eligible to participate in the study
Who cannot join
- No exclusion criteria
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera di Padova, University of Padova
Padova, 35128
University of Padova
Padova
About this study
Official title: Time of Initiation of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid: a Cross-over Randomized, Control Trial
Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as a routine and they suggest to start ventilation within the first minute of life, which may be critical to reverse asphyxia and stabilize the neonate. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials. Besides that, the delay in the beginning of the PPV in these babies has not been previously explored.
Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.
Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.
Read the detailed description
Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as a routine and they suggest to start ventilation within the first minute of life, which may be critical to reverse asphyxia and stabilize the neonate. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials. Besides that, the delay in the beginning of the PPV in these babies has not been previously explored.
Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.
Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.
- Being tested
- Endotracheal suctioning, No endotracheal suctioning
- Keywords
- Infant newborn, Meconium Aspiration Syndrome, Neonatal Resuscitation, Positive Pressure Ventilation
- Medical subject headings
- Meconium Aspiration Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal suctioningProcedure or surgery
Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation
No endotracheal suctioningProcedure or surgery
Procedure includes: immediate initiation of positive pressure ventilation without intubation and tracheal suctioning
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal suctioning | Experimental | Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation Receives: Procedure: Endotracheal suctioning |
| No endotracheal suctioning | Active comparator | Procedure includes: Initiation of positive pressure ventilation without endotracheal suctioning Receives: Procedure: No endotracheal suctioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of initiation of positive pressure ventilation
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start16 Sep 2019
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Meconium Aspiration SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076189
- Sponsor's protocol ID
- UHPadova02/2019
- Acronym
- MASTIME
- Status last verified
- Apr 2020
- First submitted
- 29 Aug 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
PubMed 26477415Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
PubMed 26473001Chettri S, Adhisivam B, Bhat BV. Endotracheal Suction for Nonvigorous Neonates Born through Meconium Stained Amniotic Fluid: A Randomized Controlled Trial. J Pediatr. 2015 May;166(5):1208-1213.e1. doi: 10.1016/j.jpeds.2014.12.076. Epub 2015 Feb 4.
PubMed 25661412Nangia S, Sunder S, Biswas R, Saili A. Endotracheal suction in term non vigorous meconium stained neonates-A pilot study. Resuscitation. 2016 Aug;105:79-84. doi: 10.1016/j.resuscitation.2016.05.015. Epub 2016 May 30.
PubMed 27255954Chiruvolu A, Miklis KK, Chen E, Petrey B, Desai S. Delivery Room Management of Meconium-Stained Newborns and Respiratory Support. Pediatrics. 2018 Dec;142(6):e20181485. doi: 10.1542/peds.2018-1485. Epub 2018 Nov 1.
PubMed 30385640
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Initiation of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid: a Cross-over Randomized, Control Trial
- ClinicalTrials.gov ID
- NCT04076189
- Acronym / sponsor ID
- MASTIME / UHPadova02/2019
- Keywords
- Infant newborn, Meconium Aspiration Syndrome, Neonatal Resuscitation, Positive Pressure Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 3 Sep 2019 (actual)
- 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.
Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as a routine and they suggest to start ventilation within the first minute of life, which may be critical to reverse asphyxia and stabilize the neonate. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials. Besides that, the delay in the beginning of the PPV in these babies has not been previously explored.
Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.
Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.
Detailed description
Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as a routine and they suggest to start ventilation within the first minute of life, which may be critical to reverse asphyxia and stabilize the neonate. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials. Besides that, the delay in the beginning of the PPV in these babies has not been previously explored.
Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin.
Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal suctioning | Experimental | Procedure: Endotracheal suctioningProcedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation |
| No endotracheal suctioning | Active comparator | Procedure: No endotracheal suctioningProcedure includes: Initiation of positive pressure ventilation without endotracheal suctioning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Level III NICU consultants, residents, and fellows trained in advanced airway management will be eligible to participate in the study
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Endotracheal suctioningProcedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation | Procedure or surgery | Endotracheal suctioning |
| No endotracheal suctioningProcedure includes: immediate initiation of positive pressure ventilation without intubation and tracheal suctioning | Procedure or surgery | No endotracheal suctioning |
Primary outcome
Time of initiation of positive pressure ventilation
Time frame: 3 minutes
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 6 Apr 2020.
- Background: PubMed 26477415Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 26473001Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
- Background: PubMed 25661412Chettri S, Adhisivam B, Bhat BV. Endotracheal Suction for Nonvigorous Neonates Born through Meconium Stained Amniotic Fluid: A Randomized Controlled Trial. J Pediatr. 2015 May;166(5):1208-1213.e1. doi: 10.1016/j.jpeds.2014.12.076. Epub 2015 Feb 4.
- Background: PubMed 27255954Nangia S, Sunder S, Biswas R, Saili A. Endotracheal suction in term non vigorous meconium stained neonates-A pilot study. Resuscitation. 2016 Aug;105:79-84. doi: 10.1016/j.resuscitation.2016.05.015. Epub 2016 May 30.
- Background: PubMed 30385640Chiruvolu A, Miklis KK, Chen E, Petrey B, Desai S. Delivery Room Management of Meconium-Stained Newborns and Respiratory Support. Pediatrics. 2018 Dec;142(6):e20181485. doi: 10.1542/peds.2018-1485. Epub 2018 Nov 1.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal suctioning and No endotracheal suctioning in people with Meconium Aspiration Syndrome and Infant, Newborn, Disease, run by University Hospital Padova at 2 sites in Italy.
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 1 inclusion and 1 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Time of initiation of positive pressure ventilation (time frame: 3 minutes). 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 NCT04076189, which also lists 5 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 6 Apr 2020.