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Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

NCT ID: NCT01197807

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Pregnancy, Childbirth and the Puerperium Resuscitation

Keywords

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Suctioning Wiping Neonate Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bulb suctioning

Bulb suctioning of mouth and nose immediately after delivery

Group Type ACTIVE_COMPARATOR

Bulb Suctioning

Intervention Type PROCEDURE

Bulb suctioning of the mouth then the nose immediately following delivery

Wiping

Gentle wiping of mouth then nose with soft cloth

Group Type ACTIVE_COMPARATOR

Wiping

Intervention Type PROCEDURE

Gentle wiping of mouth then nose with a soft cloth immediately following delivery

Interventions

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Bulb Suctioning

Bulb suctioning of the mouth then the nose immediately following delivery

Intervention Type PROCEDURE

Wiping

Gentle wiping of mouth then nose with a soft cloth immediately following delivery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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John Kelleher, MD

Fellow Instructor, Department of Pediatrics, Division of Neonatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Kelleher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Waldemar A Carlo, MD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Kelleher J, Bhat R, Salas AA, Addis D, Mills EC, Mallick H, Tripathi A, Pruitt EP, Roane C, McNair T, Owen J, Ambalavanan N, Carlo WA. Oronasopharyngeal suction versus wiping of the mouth and nose at birth: a randomised equivalency trial. Lancet. 2013 Jul 27;382(9889):326-30. doi: 10.1016/S0140-6736(13)60775-8. Epub 2013 Jun 3.

Reference Type DERIVED
PMID: 23739521 (View on PubMed)

Other Identifiers

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UAB Neo 001

Identifier Type: -

Identifier Source: org_study_id