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NCT00729989 Clinical Trial

Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

Respiratory Distress Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00729989
Other study ID # 200804774
Secondary ID
Status Terminated
Phase N/A
First received August 5, 2008
Last updated March 8, 2017
Start date August 2008
Est. completion date April 2010

Study information
Verified date March 2017
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 173
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 7 Days
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Prematurity

- Congenital Abnormality

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Gastric suctioning
The stomach will be suctioned shortly following birth with an orogastric tube

Locations
Country Name City State
United States University of Iowa Children's Hospital Iowa City Iowa

Sponsors (2)
Lead Sponsor Collaborator
Benjamin T. Stevens Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Distress Birth
Secondary Apgar scores Birth
Secondary Successful feeding/weight gain Birth
Secondary Hospital length of stay Birth
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