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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Pregnancy, Childbirth and the Puerperium
Resuscitation

Treatments

Procedure: Wiping
Procedure: Bulb Suctioning

Study type

Interventional

Funder types

Other

Identifiers

NCT01197807
UAB Neo 001

Details and patient eligibility

About

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.

Enrollment

506 patients

Sex

All

Ages

1 to 1 minute old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

506 participants in 2 patient groups

Bulb suctioning
Active Comparator group
Description:
Bulb suctioning of mouth and nose immediately after delivery
Treatment:
Procedure: Bulb Suctioning
Wiping
Active Comparator group
Description:
Gentle wiping of mouth then nose with soft cloth
Treatment:
Procedure: Wiping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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