Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid

Study Overview
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Brief Summary
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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
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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.

Official Title
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Time of Initiation of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid: a Cross-over Randomized, Control Trial

Conditions
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Meconium Aspiration Syndrome, Infant, Newborn, Disease, Neonatal Resuscitation

Intervention / Treatment
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* Procedure: Endotracheal suctioning
* Procedure: No endotracheal suctioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Level III NICU consultants, residents, and fellows trained in advanced airway management will be eligible to participate in the study Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endotracheal suctioning<br>Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation | Procedure: Endotracheal suctioning<br>* Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation<br>|
| Active Comparator: No endotracheal suctioning<br>Procedure includes: Initiation of positive pressure ventilation without endotracheal suctioning | Procedure: No endotracheal suctioning<br>* Procedure includes: immediate initiation of positive pressure ventilation without intubation and tracheal suctioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of initiation of positive pressure ventilation |  | 3 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant newborn, Meconium Aspiration Syndrome, Neonatal Resuscitation, Positive Pressure Ventilation