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Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University of Iowa.
Recruitment status was:  Not yet recruiting
Thrasher Research Fund
Information provided by:
University of Iowa Identifier:
First received: August 5, 2008
Last updated: August 7, 2008
Last verified: August 2008
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.

Condition Intervention
Respiratory Distress
Procedure: Gastric suctioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial

Resource links provided by NLM:

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Respiratory Distress [ Time Frame: Birth ]

Secondary Outcome Measures:
  • Apgar scores [ Time Frame: Birth ]
  • Successful feeding/weight gain [ Time Frame: Birth ]
  • Hospital length of stay [ Time Frame: Birth ]

Estimated Enrollment: 5000
Study Start Date: August 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2 Procedure: Gastric suctioning
The stomach will be suctioned shortly following birth with an orogastric tube


Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Prematurity
  • Congenital Abnormality
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00729989

United States, Iowa
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Thrasher Research Fund
  More Information

Responsible Party: Benjamin T. Stevens, University of Iowa Identifier: NCT00729989     History of Changes
Other Study ID Numbers: 200804774 
Study First Received: August 5, 2008
Last Updated: August 7, 2008

Keywords provided by University of Iowa:
Meconium Aspiration
Respiratory Distress
Meconium Stained Amniotic Fluid processed this record on February 17, 2017