NCT02708563

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
3.3 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

March 2, 2016

Last Update Submit

July 29, 2019

Conditions

Meconium Aspiration Syndrome

Keywords

meconiumneonatal resuscitation

Outcome Measures

Primary Outcomes (2)

  • Ability to identify, consent, enroll and randomize 70% of eligible infants into study.

    Feasibility measures

    18 months

  • The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die

    Clinical outcome measure

    18 months

Study Arms (2)

Immediate intubation

EXPERIMENTAL

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

Procedure: Immediate intubation

Immediate resuscitation

EXPERIMENTAL

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

Procedure: Immediate resuscitation

Interventions

Immediate intubationPROCEDURE

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

Immediate intubation
Immediate resuscitationPROCEDURE

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

Immediate resuscitation

Eligibility Criteria

AgeUp to 5 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term newborns (\>37 weeks of gestation)
  • Delivery through meconium-stained amniotic fluid
  • Mothers \>18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration DisordersFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 15, 2016

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share