NCT01197807

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
506

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

September 2, 2010

Last Update Submit

August 12, 2012

Conditions

Pregnancy, Childbirth and the PuerperiumResuscitation

Keywords

SuctioningWipingNeonateResuscitation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Apgar Scores at one minute of age

    1 minute of age

  • Number of newborns with tachypnea

    24 hours

  • Need for delivery room resuscitation

    1 hour after birth

  • Admission to the Neonatal Intensive Care Unit

    1 hour after birth

  • Oxygen saturations prior to discharge from hospital

    5 days of age

  • +1 more secondary outcomes

Study Arms (2)

Bulb suctioning

ACTIVE COMPARATOR

Bulb suctioning of mouth and nose immediately after delivery

Procedure: Bulb Suctioning

Wiping

ACTIVE COMPARATOR

Gentle wiping of mouth then nose with soft cloth

Procedure: Wiping

Interventions

Bulb SuctioningPROCEDURE

Bulb suctioning of the mouth then the nose immediately following delivery

Bulb suctioning
WipingPROCEDURE

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

Wiping

Eligibility Criteria

Age1 Minute - 1 Minute
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn neonates at the UAB hospital with gestational age greater than or equal to 35 weeks.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 23739521DERIVED

Study Officials

  • John Kelleher, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Waldemar A Carlo, MD

    University of Alabama at Birmingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow Instructor, Department of Pediatrics, Division of Neonatology

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 9, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

US(1)