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

Not Applicable

Completed

• Conditions: Meconium Aspiration Syndrome; Infant, Newborn, Disease; Neonatal Resuscitation
• Interventions: Procedure: Endotracheal suctioning; Procedure: No endotracheal suctioning

• Registration Number: NCT04076189
• Lead Sponsor: University Hospital Padova

Brief 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 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 Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2019-09-16
• Primary Completion: 2019-09-24
• Study Completion: 2019-09-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Level III NICU consultants, residents, and fellows trained in advanced airway management will be eligible to participate in the study

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Exclusion Criteria

• No exclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Endotracheal suctioning	Endotracheal suctioning	Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation
No endotracheal suctioning	No endotracheal suctioning	Procedure includes: Initiation of positive pressure ventilation without endotracheal suctioning

Primary Outcome Measures

Name	Time	Method
Time of initiation of positive pressure ventilation	3 minutes

Trial Locations

Locations (2)

Azienda Ospedaliera di Padova, University of Padova; 🇮🇹 Padova, Italy

University of Padova; 🇮🇹 Padova, Italy