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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Kelleher, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01197807
First received: September 2, 2010
Last updated: August 12, 2012
Last verified: August 2012

September 2, 2010
August 12, 2012
November 2010
November 2011   (final data collection date for primary outcome measure)
Mean respiratory rate over the first 24 hours of life [ Time Frame: 24 hours after birth ] [ Designated as safety issue: Yes ]
Respiratory rates measured every 8 hours during the first 24 hours after birth
Mean respiratory rate over the first 24 hours of life [ Time Frame: 24 hours after birth ] [ Designated as safety issue: Yes ]
Respiratory rates measured at 6, 12, 18, and 24 hours of life
Complete list of historical versions of study NCT01197807 on ClinicalTrials.gov Archive Site
  • Apgar Scores at one minute of age [ Time Frame: 1 minute of age ] [ Designated as safety issue: No ]
    Independent assignment of Apgar Scores at one minute of age
  • Number of newborns with tachypnea [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Number of newborns with tachypnea as defined by respiratory rate greater than 60 breaths per minute
  • Need for delivery room resuscitation [ Time Frame: 1 hour after birth ] [ Designated as safety issue: Yes ]
    Need for delivery room resuscitation including suctioning, intubation, positive pressure ventilation, chest compressions, and/or medication
  • Admission to the Neonatal Intensive Care Unit [ Time Frame: 1 hour after birth ] [ Designated as safety issue: Yes ]
    Needing admission to the Neonatal Intensive Care Unit
  • Oxygen saturations prior to discharge from hospital [ Time Frame: 5 days of age ] [ Designated as safety issue: No ]
    Measurements of oxygen saturations in the well baby nursery prior to discharge home
  • Apgar score at 5 minutes of age [ Time Frame: 5 minutes of age ] [ Designated as safety issue: No ]
    Independent assignment of Apgar score at 5 minutes of age
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy, Childbirth and the Puerperium
  • Resuscitation
  • 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
  • Active Comparator: Bulb suctioning
    Bulb suctioning of mouth and nose immediately after delivery
    Intervention: Procedure: Bulb Suctioning
  • Active Comparator: Wiping
    Gentle wiping of mouth then nose with soft cloth
    Intervention: Procedure: Wiping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
506
January 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
up to 1 Minute
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01197807
UAB Neo 001
Yes
John Kelleher, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: John Kelleher, MD University of Alabama at Birmingham
Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
University of Alabama at Birmingham
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP