Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Distress
• Intervention / Treatment: Procedure: Gastric suctioning

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Prematurity
• Congenital Abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory Distress	Birth

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benjamin T. Stevens
• Collaborators: Thrasher Research Fund

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Respiratory Distress; Meconium Aspiration; Meconium Stained Amniotic Fluid
• Other Study ID Numbers: 200804774