Meconium Aspiration and Tracheal Suctioning-Feasibility Study

NCT ID: NCT02708563

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Meconium Aspiration Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate intubation

These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines.

Group Type EXPERIMENTAL

Immediate intubation

Intervention Type PROCEDURE

Infants that are not vigorous at delivery will receive immediate tracheal suctioning

Immediate resuscitation

These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning.

Group Type EXPERIMENTAL

Immediate resuscitation

Intervention Type PROCEDURE

Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed

Interventions

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Immediate intubation

Infants that are not vigorous at delivery will receive immediate tracheal suctioning

Intervention Type PROCEDURE

Immediate resuscitation

Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

5 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Pediatrics

OTHER

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Marya Strand, MD

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SLU-19817

Identifier Type: -

Identifier Source: org_study_id

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