Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Iowa.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00729989
First received: August 5, 2008
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Apgar scores [ Time Frame: Birth ] [ Designated as safety issue: No ]
  • Successful feeding/weight gain [ Time Frame: Birth ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Birth ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00729989

Contacts
Contact: Benjamin T Stevens, MD 319-384-6576 benjamin-stevens@uiowa.edu

Locations
United States, Iowa
University of Iowa Children's Hospital Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Benjamin T Stevens, MD    319-384-6576    benjamin-stevens@uiowa.edu   
Principal Investigator: Benjamin T Stevens, MD         
Sponsors and Collaborators
University of Iowa
Thrasher Research Fund
  More Information

No publications provided

Responsible Party: Benjamin T. Stevens, University of Iowa
ClinicalTrials.gov Identifier: NCT00729989     History of Changes
Other Study ID Numbers: 200804774
Study First Received: August 5, 2008
Last Updated: August 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Meconium Aspiration
Respiratory Distress
Meconium Stained Amniotic Fluid

ClinicalTrials.gov processed this record on August 18, 2014