Clinical Trials Directory

Trials / Completed

CompletedNCT01197807

Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
506 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
1 Minute – 1 Minute
Healthy volunteers
Not accepted

Summary

Until recently, bulb or catheter oronasopharyngeal suctioning (ONPS) of all the infants, including vigorous infants in the delivery room, has been featured as a standard of newborn care. The 5th edition of the Newborn Resuscitation Program (NRP) has minimized the recommendation for routine suctioning of infants following delivery, provided they are not depressed or in need of immediate resuscitation. However, this new alternative recommendation was based on a small randomized trial and other lower level evidence rather than evidence from larger trials. The NRP Textbook cautions against vigorous suctioning because of the resultant apnea or bradycardia. Furthermore, suctioning may delay other more important steps of resuscitation. Thus, it is necessary to compare the alternative recommended practice, i.e. simple wiping of the mouth, to determine if it has equivalent efficacy and a favorable side effect profile compared to suctioning.

Conditions

Interventions

TypeNameDescription
PROCEDUREBulb SuctioningBulb suctioning of the mouth then the nose immediately following delivery
PROCEDUREWipingGentle wiping of mouth then nose with a soft cloth immediately following delivery

Timeline

Start date
2010-11-01
Primary completion
2011-11-01
Completion
2012-01-01
First posted
2010-09-09
Last updated
2012-08-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01197807. Inclusion in this directory is not an endorsement.