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NCT02708563 Clinical Trial

Meconium Aspiration and Tracheal Suctioning—Feasibility Study

Meconium Aspiration Syndrome Clinical Trial

— MATS  

Official title:
Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02708563
Other study ID # SLU-19817
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2019
Est. completion date July 2021

Study information
Verified date July 2019
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2021
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Minutes
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Immediate intubation
Infants that are not vigorous at delivery will receive immediate tracheal suctioning
• Immediate resuscitation
Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
St. Louis University American Academy of Pediatrics

Outcome
Type Measure Description Time frame Safety issue
Primary Ability to identify, consent, enroll and randomize 70% of eligible infants into study. Feasibility measures 18 months
Primary The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die Clinical outcome measure 18 months
See also
  Status Clinical Trial Phase
Completed NCT02041546 - Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome Phase 4
Completed NCT04076189 - Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid N/A
Not yet recruiting NCT02571231 - High Flow Ventilation With Volume Guarantee N/A
Completed NCT01758822 - Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Babies N/A
Completed NCT01328483 - Effect Of Intrapartum Oropharyngeal (IP-OP) Suction on Meconium Aspiration Syndrome N/A
Recruiting NCT06090981 - Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome N/A
Withdrawn NCT03996317 - Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities N/A
Completed NCT01310621 - Comparison Of Surfactant Lung Lavage With Standard Care In The Treatment Of Meconium Aspiration Syndrome N/A
Recruiting NCT03346343 - Pulmonary Function Using Non-invasive Forced Oscillometry N/A
Completed NCT01757782 - Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns Phase 4
Completed NCT01274845 - Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome N/A
Recruiting NCT00312507 - Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration Phase 3