Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

NCT ID: NCT00729989

Last Updated: 2017-03-13

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

TERMINATED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-04-30

Brief Summary

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The stomach of the newborn baby is often emptied soon after birth to prevent breathing problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those with increased secretions associated with birth by C-section are thought to be at particular risk of breathing problems during the first minutes of life. Emptying the stomach by sucking out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and improve respiratory distress. This study will evaluate the usefulness of gastric suctioning during neonatal resuscitation.

Detailed Description

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Conditions

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Respiratory Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Group Type EXPERIMENTAL

Gastric suctioning

Intervention Type PROCEDURE

The stomach will be suctioned shortly following birth with an orogastric tube

Interventions

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Gastric suctioning

The stomach will be suctioned shortly following birth with an orogastric tube

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Term infant with meconium stained amniotic fluid or born by C-section

Exclusion Criteria

* Prematurity
* Congenital Abnormality
Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

Benjamin T. Stevens

OTHER

Sponsor Role lead

Responsible Party

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Benjamin T. Stevens

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Iowa Children's Hospital

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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200804774

Identifier Type: -

Identifier Source: org_study_id

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