Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

Resuscitation Clinical Trial

— TermWIPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197807
• Other study ID #: UAB Neo 001
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: August 12, 2012
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Minute

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy, Childbirth and the Puerperium
• Resuscitation

Intervention

Procedure:
• Bulb Suctioning
Bulb suctioning of the mouth then the nose immediately following delivery
• Wiping
Gentle wiping of mouth then nose with a soft cloth immediately following delivery

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean respiratory rate over the first 24 hours of life	Respiratory rates measured every 8 hours during the first 24 hours after birth	24 hours after birth	Yes
Secondary	Apgar Scores at one minute of age	Independent assignment of Apgar Scores at one minute of age	1 minute of age	No
Secondary	Number of newborns with tachypnea	Number of newborns with tachypnea as defined by respiratory rate greater than 60 breaths per minute	24 hours	No
Secondary	Need for delivery room resuscitation	Need for delivery room resuscitation including suctioning, intubation, positive pressure ventilation, chest compressions, and/or medication	1 hour after birth	Yes
Secondary	Admission to the Neonatal Intensive Care Unit	Needing admission to the Neonatal Intensive Care Unit	1 hour after birth	Yes
Secondary	Oxygen saturations prior to discharge from hospital	Measurements of oxygen saturations in the well baby nursery prior to discharge home	5 days of age	No
Secondary	Apgar score at 5 minutes of age	Independent assignment of Apgar score at 5 minutes of age	5 minutes of age	No