Clinical trial NCT01197807: Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns
Official title: Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, Childbirth and the Puerperium
Resuscitation
Keywords: Suctioning
Wiping
Neonate
Resuscitation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 506
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean respiratory rate over the first 24 hours of life
timeFrame: 24 hours after birth
Secondary outcomes:
measure: Apgar Scores at one minute of age
timeFrame: 1 minute of age
measure: Number of newborns with tachypnea
timeFrame: 24 hours
measure: Need for delivery room resuscitation
timeFrame: 1 hour after birth
measure: Admission to the Neonatal Intensive Care Unit
timeFrame: 1 hour after birth
measure: Oxygen saturations prior to discharge from hospital
timeFrame: 5 days of age
measure: Apgar score at 5 minutes of age
timeFrame: 5 minutes of age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: John Kelleher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
References:
citation: 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.