Pregnancy, Childbirth and the PuerperiumTermWIPENCT01197807
Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns
A study testing Bulb Suctioning and Wiping in people with Pregnancy, Childbirth and the Puerperium and Resuscitation, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 to 1 minute
- Conditions the study is for
- Pregnancy, Childbirth and the Puerperium, Resuscitation
- What is being tested?
- Bulb Suctioning and Wiping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn neonates at the UAB hospital with gestational age greater than or equal to 35 weeks.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns
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.
- Being tested
- Bulb Suctioning, Wiping
- Keywords
- Suctioning, Wiping, Neonate, Resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulb SuctioningProcedure or surgery
Bulb suctioning of the mouth then the nose immediately following delivery
WipingProcedure or surgery
Gentle wiping of mouth then nose with a soft cloth immediately following delivery
| Study group | Role | What they receive |
|---|---|---|
| Bulb suctioning | Active comparator | Bulb suctioning of mouth and nose immediately after delivery Receives: Procedure: Bulb Suctioning |
| Wiping | Active comparator | Gentle wiping of mouth then nose with soft cloth Receives: Procedure: Wiping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean respiratory rate over the first 24 hours of life
Respiratory rates measured every 8 hours during the first 24 hours after birth
Measured: 24 hours after birth
Secondary outcomes (6)
Apgar Scores at one minute of age
Independent assignment of Apgar Scores at one minute of age
Measured: 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
Measured: 24 hours
Need for delivery room resuscitation
Need for delivery room resuscitation including suctioning, intubation, positive pressure ventilation, chest compressions, and/or medication
Measured: 1 hour after birth
Admission to the Neonatal Intensive Care Unit
Needing admission to the Neonatal Intensive Care Unit
Measured: 1 hour after birth
Oxygen saturations prior to discharge from hospital
Measurements of oxygen saturations in the well baby nursery prior to discharge home
Measured: 5 days of age
Apgar score at 5 minutes of age
Independent assignment of Apgar score at 5 minutes of age
Measured: 5 minutes of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, Childbirth and the PuerperiumStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kelleher, MD, University of Alabama at Birmingham
- Investigators
- John Kelleher, MD, Principal investigator, University of Alabama at BirminghamWaldemar A Carlo, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197807
- Sponsor's protocol ID
- UAB Neo 001
- Acronym
- TermWIPE
- Status last verified
- Aug 2012
- First submitted
- 2 Sep 2010
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23739521
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Resuscitation: A Randomized Controlled Trial of Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns
- ClinicalTrials.gov ID
- NCT01197807
- Acronym / sponsor ID
- TermWIPE / UAB Neo 001
- Keywords
- Suctioning, Wiping, Neonate, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bulb suctioning | Active comparator | Procedure: Bulb SuctioningBulb suctioning of mouth and nose immediately after delivery |
| Wiping | Active comparator | Procedure: WipingGentle wiping of mouth then nose with soft cloth |
Who may qualify
- Ages
- 1 to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inborn neonates at the UAB hospital with gestational age greater than or equal to 35 weeks.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulb SuctioningBulb suctioning of the mouth then the nose immediately following delivery | Procedure or surgery | Bulb suctioning |
| WipingGentle wiping of mouth then nose with a soft cloth immediately following delivery | Procedure or surgery | Wiping |
Primary outcome
Mean respiratory rate over the first 24 hours of life
Time frame: 24 hours after birth
Respiratory rates measured every 8 hours during the first 24 hours after birth
6 secondary outcomes
Apgar Scores at one minute of age
Time frame: 1 minute of age
Number of newborns with tachypnea
Time frame: 24 hours
Need for delivery room resuscitation
Time frame: 1 hour after birth
Admission to the Neonatal Intensive Care Unit
Time frame: 1 hour after birth
Oxygen saturations prior to discharge from hospital
Time frame: 5 days of age
Apgar score at 5 minutes of age
Time frame: 5 minutes of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Derived from this study: PubMed 23739521Kelleher 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kelleher, MD principal investigator
University of Alabama at Birmingham
Waldemar A Carlo, MD study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulb Suctioning and Wiping in people with Pregnancy, Childbirth and the Puerperium and Resuscitation, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean respiratory rate over the first 24 hours of life (time frame: 24 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.