Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

Not Applicable

Completed

• Conditions: Resuscitation; Pregnancy, Childbirth and the Puerperium
• Interventions: Procedure: Wiping; Procedure: Bulb Suctioning

• Registration Number: NCT01197807
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-09
• Study Start: 2010-11
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-12
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 506

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wiping	Wiping	Gentle wiping of mouth then nose with soft cloth
Bulb suctioning	Bulb Suctioning	Bulb suctioning of mouth and nose immediately after delivery

Primary Outcome Measures

Name	Time	Method
Mean respiratory rate over the first 24 hours of life	24 hours after birth	Respiratory rates measured every 8 hours during the first 24 hours after birth

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States