Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns (TermWIPE)
This study has been completed.
Sponsor:
University of Alabama at Birmingham
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy, Childbirth and the Puerperium Resuscitation |
Procedure: Bulb Suctioning Procedure: Wiping |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns |
Further study details as provided by University of Alabama at Birmingham:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 506 |
| Study Start Date: | November 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | up to 1 Minute |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197807
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
| Principal Investigator: | John Kelleher, MD | University of Alabama at Birmingham |
| Study Director: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | John Kelleher, MD, Fellow Instructor, Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01197807 History of Changes |
| Other Study ID Numbers: | UAB Neo 001 |
| Study First Received: | September 2, 2010 |
| Last Updated: | August 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
Suctioning Wiping Neonate Resuscitation |
ClinicalTrials.gov processed this record on May 16, 2013