Efficacy and Safety of Gastric Suctioning During Neonatal... | NCT00729989

Studies
Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

NCT00729989

Sponsor

Benjamin T. Stevens

Status

Terminated

Last Update Posted

Mar 13, 2017Actual

Enrollment

173Actual

Phase

Not Applicable

Conditions

Respiratory Distress

Interventions

Gastric suctioning

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Project not funded

Expanded Access Info

Start Date

Aug 2008Actual

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Aug 5, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2017

Last Update Posted Date

Mar 13, 2017Actual

Name	Class
Thrasher Research Fund	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention
2	Experimental		Procedure: Gastric suctioning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric suctioning	Procedure	The stomach will be suctioned shortly following birth with an orogastric tube	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory Distress		Birth

Secondary Outcomes

Measure	Description	Time Frame
Apgar scores		Birth
Successful feeding/weight gain		Birth
Hospital length of stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Prematurity
Congenital Abnormality

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa Children's Hospital		Iowa City	Iowa	52242	United States

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea
D008471	Meconium Aspiration Syndrome

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided