Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

Study Overview
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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.

Official Title
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Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns

Conditions
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Pregnancy, Childbirth and the Puerperium, Resuscitation

Intervention / Treatment
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* Procedure: Bulb Suctioning
* Procedure: Wiping


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bulb suctioning<br>Bulb suctioning of mouth and nose immediately after delivery | Procedure: Bulb Suctioning<br>* Bulb suctioning of the mouth then the nose immediately following delivery<br>|
| Active Comparator: Wiping<br>Gentle wiping of mouth then nose with soft cloth | Procedure: Wiping<br>* Gentle wiping of mouth then nose with a soft cloth immediately following delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suctioning, Wiping, Neonate, Resuscitation