By Brian Hoyle
BOSTON -- May 3, 2012 -- Comparison of the traditional neonatal
oronasopharyngeal suctioning (ONPS) versus wiping of the mouth and nose has
demonstrated the equivalent outcome in terms of respiratory rate in the first
day after birth, according to a study presented here at the 2012 Pediatric
Academic Societies (PAS).
“Suctioning of neonates is a common procedure throughout the world. It can
reduce airway resistance, stimulate breathing, and prevent aspiration.
Nevertheless, adverse effects of suctioning include apnoea and bradycardia,”
explained John Kelleher, MD, Department of Pediatrics, University of Alabama,
Birmingham, Alabama, on April 29. “Wiping of the mouth and nose as an
alternative to suctioning has been recommended by the [AAP] beginning in 2005.
However, large randomised trials comparing wiping and suctioning have not been
done,” he continued.
The driving hypothesis of this trial was that wiping is equivalent to ONPS in
terms of mean respiratory rate, as judged by a difference of <4 br="" breaths="" min=""> during the first 24 hours after birth. A mean difference of ≥4 breaths/min
would indicate nonequivalence of the approaches.
All newborns aged ≥35 weeks who were delivered at the participating hospital
from October 2010 to November 2011 were eligible for inclusion. Infants were
excluded if they had known congenital anomalies or were not vigourous with
meconium-stained amniotic fluid.
After consent for participation, 503 women were randomised before delivery to
treatment by wiping (intervention group, n = 256) or ONPS (control group, n =
247). The primary outcome was mean respiratory rate recorded manually over 60
seconds at 1, 8, 16, and 24 hours during the first 24 hours after birth. It was
impossible to completely blind those doing the measurements to the study arms.
Secondary outcomes were Apgar scores, delivery room resuscitation, number of
newborns with a respiratory rate >60 breaths/min anytime during the first 24
hours post partum, and admission to the neonatal intensive care unit. Analysis
was by intention to treat.
The mean respiratory rate of the neonates receiving the wipe treatment was
equivalent to the ONPS group of neonates (51 vs 50 breaths/min, respectively;
difference of means = 1 breath/min, 95% confidence interval, -2.2 to 0.2;
P <.001). There was no significant difference between the groups
regarding any of the aforementioned secondary outcomes.
“Our results shown that wiping is equivalent to traditional bulb-and-syringe
suctioning with respect to the mean respiration rate over the first 24 hours
after birth. Wiping avoids the potential adverse effects of suctioning,” said
Dr. Kelleher, adding, “There is no difference regarding prespecified secondary
clinical outcomes,”
“I am perplexed by the use of respiratory rate as the primary outcome,”
commented attendee Lucky Jain, MD, Emory University School of Medicine,
Atlanta, Georgia. “Why not the difference in heart rate or the frequency of
cardiac episodes or something else that is related to the effects of suctioning
or wiping?”
Dr. Kelleher explained that other primary outcomes would have necessitated a
much larger and more expensive study and that the choice reflected these
considerations.
The use of ONPS as the control, rather than no treatment, was also questioned,
in light of the recognition of the adverse effects of ONPS.
“The lung fluid or the fluid that we see in the nares or the oropharynx is not
important in terms of suctioning. I hope that future trials would be wiping
versus no wiping instead of wiping versus suctioning,” said Dr. Jain.
While acknowledging the latter criticism, Dr. Kelleher argued that the study
reflects the reality, at least in the United States, of the delivery room.
“I agree that previous publications have shown that suctioning can have
deleterious consequences,” said Dr. Kelleher. “Nevertheless, it’s been my
experience that in the United States, suctioning is still firmly ingrained in
neonatal care. That is why we chose to use it in comparison with wiping,” he
explained.
The Pediatric Academic Societies (PAS) is cosponsored by the American Pediatric
Society (APS), the Society for Pediatric Research (SPR), the Academic Pediatric
Association (APA), and the American Academy of Pediatrics (AAP).
[Presentation title: A Randomized Controlled Equivalency
Trial of Oronasopharyngeal Suctioning Versus Wiping the Mouth. Abstract 2170.5]
BOSTON -- May 3, 2012 -- Comparison of the traditional neonatal
oronasopharyngeal suctioning (ONPS) versus wiping of the mouth and nose has
demonstrated the equivalent outcome in terms of respiratory rate in the first
day after birth, according to a study presented here at the 2012 Pediatric
Academic Societies (PAS).
“Suctioning of neonates is a common procedure throughout the world. It can
reduce airway resistance, stimulate breathing, and prevent aspiration.
Nevertheless, adverse effects of suctioning include apnoea and bradycardia,”
explained John Kelleher, MD, Department of Pediatrics, University of Alabama,
Birmingham, Alabama, on April 29. “Wiping of the mouth and nose as an
alternative to suctioning has been recommended by the [AAP] beginning in 2005.
However, large randomised trials comparing wiping and suctioning have not been
done,” he continued.
The driving hypothesis of this trial was that wiping is equivalent to ONPS in
terms of mean respiratory rate, as judged by a difference of <4 br="" breaths="" min=""> during the first 24 hours after birth. A mean difference of ≥4 breaths/min
would indicate nonequivalence of the approaches.
All newborns aged ≥35 weeks who were delivered at the participating hospital
from October 2010 to November 2011 were eligible for inclusion. Infants were
excluded if they had known congenital anomalies or were not vigourous with
meconium-stained amniotic fluid.
After consent for participation, 503 women were randomised before delivery to
treatment by wiping (intervention group, n = 256) or ONPS (control group, n =
247). The primary outcome was mean respiratory rate recorded manually over 60
seconds at 1, 8, 16, and 24 hours during the first 24 hours after birth. It was
impossible to completely blind those doing the measurements to the study arms.
Secondary outcomes were Apgar scores, delivery room resuscitation, number of
newborns with a respiratory rate >60 breaths/min anytime during the first 24
hours post partum, and admission to the neonatal intensive care unit. Analysis
was by intention to treat.
The mean respiratory rate of the neonates receiving the wipe treatment was
equivalent to the ONPS group of neonates (51 vs 50 breaths/min, respectively;
difference of means = 1 breath/min, 95% confidence interval, -2.2 to 0.2;
P <.001). There was no significant difference between the groups
regarding any of the aforementioned secondary outcomes.
“Our results shown that wiping is equivalent to traditional bulb-and-syringe
suctioning with respect to the mean respiration rate over the first 24 hours
after birth. Wiping avoids the potential adverse effects of suctioning,” said
Dr. Kelleher, adding, “There is no difference regarding prespecified secondary
clinical outcomes,”
“I am perplexed by the use of respiratory rate as the primary outcome,”
commented attendee Lucky Jain, MD, Emory University School of Medicine,
Atlanta, Georgia. “Why not the difference in heart rate or the frequency of
cardiac episodes or something else that is related to the effects of suctioning
or wiping?”
Dr. Kelleher explained that other primary outcomes would have necessitated a
much larger and more expensive study and that the choice reflected these
considerations.
The use of ONPS as the control, rather than no treatment, was also questioned,
in light of the recognition of the adverse effects of ONPS.
“The lung fluid or the fluid that we see in the nares or the oropharynx is not
important in terms of suctioning. I hope that future trials would be wiping
versus no wiping instead of wiping versus suctioning,” said Dr. Jain.
While acknowledging the latter criticism, Dr. Kelleher argued that the study
reflects the reality, at least in the United States, of the delivery room.
“I agree that previous publications have shown that suctioning can have
deleterious consequences,” said Dr. Kelleher. “Nevertheless, it’s been my
experience that in the United States, suctioning is still firmly ingrained in
neonatal care. That is why we chose to use it in comparison with wiping,” he
explained.
The Pediatric Academic Societies (PAS) is cosponsored by the American Pediatric
Society (APS), the Society for Pediatric Research (SPR), the Academic Pediatric
Association (APA), and the American Academy of Pediatrics (AAP).
[Presentation title: A Randomized Controlled Equivalency
Trial of Oronasopharyngeal Suctioning Versus Wiping the Mouth. Abstract 2170.5]
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