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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bulb suctioning | Active Comparator | Bulb suctioning of mouth and nose immediately after delivery |
|
| Wiping | Active Comparator | Gentle wiping of mouth then nose with soft cloth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulb Suctioning | Procedure | Bulb suctioning of the mouth then the nose immediately following delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Apgar Scores at one minute of age | Independent assignment of Apgar Scores at one minute of age | 1 minute of age |
| Number of newborns with tachypnea | Number of newborns with tachypnea as defined by respiratory rate greater than 60 breaths per minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Kelleher, MD | University of Alabama at Birmingham | Principal Investigator |
| Waldemar A Carlo, MD | University of Alabama at Birmingham | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23739521 | Derived | 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. |
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| Wiping | Procedure | Gentle wiping of mouth then nose with a soft cloth immediately following delivery |
|
| 24 hours |
| Need for delivery room resuscitation | Need for delivery room resuscitation including suctioning, intubation, positive pressure ventilation, chest compressions, and/or medication | 1 hour after birth |
| Admission to the Neonatal Intensive Care Unit | Needing admission to the Neonatal Intensive Care Unit | 1 hour after birth |
| Oxygen saturations prior to discharge from hospital | Measurements of oxygen saturations in the well baby nursery prior to discharge home | 5 days of age |
| Apgar score at 5 minutes of age | Independent assignment of Apgar score at 5 minutes of age | 5 minutes of age |