MATS: Meconium Aspiration and Tracheal Suctioning-Feasibility Study

• Sponsor: St. Louis University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02708563
• Collaborator: American Academy of Pediatrics (Other)
• Enrollment: 0
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.

Condition or Disease	Intervention/Treatment	Phase
Meconium Aspiration Syndrome	Procedure: Immediate intubation; Procedure: Immediate resuscitation	N/A

Detailed Description

This will be a pilot feasibility trial of endotracheal intubation and suctioning versus routine resuscitation for term, non-vigorous newborns born through meconium-stained amniotic fluid to compare the incidence of meconium aspiration syndrome, extracorporeal membrane oxygenation or death.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study
• Anticipated Study Start Date: Jul 1, 2019
• Anticipated Primary Completion Date: Jul 1, 2020
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate intubation These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines.	Procedure: Immediate intubation; Infants that are not vigorous at delivery will receive immediate tracheal suctioning
Experimental: Immediate resuscitation These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning.	Procedure: Immediate resuscitation; Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed

Outcome Measures

Primary Outcome Measures

1. Ability to identify, consent, enroll and randomize 70% of eligible infants into study. [18 months]

   Feasibility measures

2. The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die [18 months]

   Clinical outcome measure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 5 Minutes
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Term newborns (>37 weeks of gestation)

• Delivery through meconium-stained amniotic fluid

• Mothers >18 years of age

Exclusion Criteria:

• No consent from mother

• Infant vigor at delivery (muscle tone and respiratory effort)

• Prenatally diagnosed major anomalies (excluding gastroschisis)

• Plan to not resuscitate infant

• Family does not speak English

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• St. Louis University
• American Academy of Pediatrics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marya Strand, MD, Associate Professor of Pediatrics, St. Louis University
• ClinicalTrials.gov Identifier: NCT02708563
• Other Study ID Numbers: SLU-19817
• First Posted: Mar 15, 2016
• Last Update Posted: Jul 31, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marya Strand, MD, Associate Professor of Pediatrics, St. Louis University: meconium; neonatal resuscitation
• Additional relevant MeSH terms: Meconium Aspiration Syndrome; Syndrome

Study Results

No Results Posted as of Jul 31, 2019