Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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

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
1: No Intervention
2: Experimental	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

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

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

Keywords provided by University of Iowa:

Meconium Aspiration

Respiratory Distress

Meconium Stained Amniotic Fluid

Study placed in the following topic categories:

Meconium Aspiration Syndrome

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	University of Iowa Thrasher Research Fund
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00729989