Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns (TermWIPE)

August 12, 2012 updated by: John Kelleher, MD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

506

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 minute (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inborn neonates at the UAB hospital with gestational age greater than or equal to 35 weeks.

Exclusion Criteria:

  • Major birth anomalies or where a decision to institute comfort care only has been made antenatally
  • Significant resuscitation efforts are anticipated prior to delivery
  • Nonvigorous infants with meconium stained amniotic fluid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bulb suctioning
Bulb suctioning of mouth and nose immediately after delivery
Procedure: Bulb Suctioning
Bulb suctioning of the mouth then the nose immediately following delivery
Active Comparator: Wiping
Gentle wiping of mouth then nose with soft cloth
Procedure: Wiping
Gentle wiping of mouth then nose with a soft cloth immediately following delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean respiratory rate over the first 24 hours of life
Time Frame: 24 hours after birth
Respiratory rates measured every 8 hours during the first 24 hours after birth
24 hours after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apgar Scores at one minute of age
Time Frame: 1 minute of age
Independent assignment of Apgar Scores at one minute of age
1 minute of age
Number of newborns with tachypnea
Time Frame: 24 hours
Number of newborns with tachypnea as defined by respiratory rate greater than 60 breaths per minute
24 hours
Need for delivery room resuscitation
Time Frame: 1 hour after birth
Need for delivery room resuscitation including suctioning, intubation, positive pressure ventilation, chest compressions, and/or medication
1 hour after birth
Admission to the Neonatal Intensive Care Unit
Time Frame: 1 hour after birth
Needing admission to the Neonatal Intensive Care Unit
1 hour after birth
Oxygen saturations prior to discharge from hospital
Time Frame: 5 days of age
Measurements of oxygen saturations in the well baby nursery prior to discharge home
5 days of age
Apgar score at 5 minutes of age
Time Frame: 5 minutes of age
Independent assignment of Apgar score at 5 minutes of age
5 minutes of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 12, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UAB Neo 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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