Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729989
Recruitment Status : Terminated (Project not funded)
First Posted : August 8, 2008
Last Update Posted : March 13, 2017
Thrasher Research Fund
Information provided by (Responsible Party):
Benjamin T. Stevens, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Procedure: Gastric suctioning Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial
Actual Study Start Date : August 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 1
Experimental: 2 Procedure: Gastric suctioning
The stomach will be suctioned shortly following birth with an orogastric tube

Primary Outcome Measures :
  1. Respiratory Distress [ Time Frame: Birth ]

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729989

United States, Iowa
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Benjamin T. Stevens
Thrasher Research Fund

Responsible Party: Benjamin T. Stevens, Principal Investigator, University of Iowa Identifier: NCT00729989     History of Changes
Other Study ID Numbers: 200804774
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Benjamin T. Stevens, University of Iowa:
Meconium Aspiration
Respiratory Distress
Meconium Stained Amniotic Fluid