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

NCT04076189 | Completed

• 1 other identifier: UHPadova02/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Infant newborn; Meconium Aspiration Syndrome; Neonatal Resuscitation; Positive Pressure Ventilation

Outcome Measures

Primary Outcomes (1)

• Time of initiation of positive pressure ventilation

  3 minutes

Study Arms (2)

Endotracheal suctioning

EXPERIMENTAL

Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation

Procedure: Endotracheal suctioning

No endotracheal suctioning

ACTIVE COMPARATOR

Procedure includes: Initiation of positive pressure ventilation without endotracheal suctioning

Procedure: No endotracheal suctioning

Interventions

Endotracheal suctioning PROCEDURE

Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation

Endotracheal suctioning

No endotracheal suctioning PROCEDURE

Procedure includes: immediate initiation of positive pressure ventilation without intubation and tracheal suctioning

No endotracheal suctioning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital Padova: lead
• University of Padova: collaborator

Study Sites (2)

Azienda Ospedaliera di Padova, University of Padova

Padua, 35128, Italy

Location

University of Padova

Padua, Italy

Location

Related Publications (5)

• 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.

  PMID: 26477415 BACKGROUND

• Wyckoff 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.

  PMID: 26473001 BACKGROUND

• Chettri 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.

  PMID: 25661412 BACKGROUND

• Nangia 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.

  PMID: 27255954 BACKGROUND

• Chiruvolu 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.

  PMID: 30385640 BACKGROUND

MeSH Terms

Conditions

Meconium Aspiration Syndrome; Disease

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: September 16, 2019
• Primary Completion: September 24, 2019
• Study Completion: September 24, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (2)