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Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

NCT01197807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2012-08-14

No results posted yet for this study

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

  • Pregnancy, Childbirth and the Puerperium
  • Resuscitation

Interventions

PROCEDURE

Bulb Suctioning

Bulb suctioning of the mouth then the nose immediately following delivery

PROCEDURE

Wiping

Gentle wiping of mouth then nose with a soft cloth immediately following delivery

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • John Kelleher, MD · University of Alabama at Birmingham

  • Waldemar A Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
1 Minute
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-11-30
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197807 on ClinicalTrials.gov