NCT00729989

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

August 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

August 5, 2008

Last Update Submit

March 8, 2017

Conditions

Respiratory Distress

Keywords

Meconium AspirationRespiratory DistressMeconium Stained Amniotic Fluid

Outcome Measures

Primary Outcomes (1)

  • Respiratory Distress

    Birth

Secondary Outcomes (3)

  • Apgar scores

    Birth

  • Successful feeding/weight gain

    Birth

  • Hospital length of stay

    Birth

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL
Procedure: Gastric suctioning

Interventions

Gastric suctioningPROCEDURE

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

2

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Prematurity
  • Congenital Abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Children's Hospital

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

DyspneaMeconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung InjuryLung DiseasesFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

August 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

US(1)