Neonatal ResuscitationNCT02629887
Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation
A study testing Non-inflatable supraglottic airway, Face Mask and T-Piece Resuscitator in people with Neonatal Resuscitation, run by University of Oklahoma at 1 site in United States.
Trial summary
Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with… Read more about this study
- Who is it for?
- Ages Up to 30 minutes
- Conditions the study is for
- Neonatal Resuscitation
- What is being tested?
- Non-inflatable supraglottic airway, Face Mask and T-Piece Resuscitator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2018to 15 Apr 2018
- 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 Up to 30 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns > or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life
Who cannot join
- Newborns with expected fetal weight <2000 grams
- Known congenital malformations
- Multiple gestation (twins and above)
- History of meconium stained fluid
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation: A Pilot Study
Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.
Read the detailed description
Mothers who are close to delivery of a term or near term infant with estimated fetal weight of 2500gms will be approached for consent to randomize their infant to resuscitation with mask or non-inflatable supraglottic airway (NISGA) if resuscitation is required. Study personnel in delivery will open sequential envelopes with randomized code to indicate which device is to be used if necessary. The resuscitator will be blinded until determination of need of respiratory support. At that time, the appropriate randomized device (face mask or NISGA) will be handed to the resuscitator for use along with T-Piece resuscitator. Video data capture will be used to record type, length and response to resuscitation. This information will be translated to a database prior to destruction of video.
- Conditions
- Neonatal Resuscitation
- Being tested
- Non-inflatable supraglottic airway, Face Mask, T-Piece Resuscitator
- Keywords
- supraglottic airway, neonatal resuscitation, ventilation, term infant
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-inflatable supraglottic airwayDevice
at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.
Face MaskDevice
at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.
T-Piece ResuscitatorDevice
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway
| Study group | Role | What they receive |
|---|---|---|
| Face Mask | Active comparator | Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline. Receives: Device: Face Mask; Device: T-Piece Resuscitator |
| Non-inflatable supraglottic airway | Active comparator | Use of non-inflating supraglottic airway with T-piece resuscitator instead of Standard Face Mask with T piece resuscitator for neonatal resuscitation, replacing standard of care face mask in Neonatal Resuscitation Program guideline. Receives: Device: Non-inflatable supraglottic airway; Device: T-Piece Resuscitator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Spontaneous Breathing
Record of time from beginning of resuscitation to time of spontaneous breathing
Measured: 30 minutes
Duration of Positive Pressure Ventilation
Total time of positive pressure ventilation required to adequate spontaneous breathing.
Measured: 30 minutes
Need for subsequent endotracheal intubation
Failure of non-invasive resuscitative efforts by face mask or NI-SGA requiring intubation per NRP guideline.
Measured: 30 minutes
Secondary outcomes (7)
Time needed for NI-SGA placement
Time needed adequate placement of non-inflatable supraglottic airway
Measured: 1 minute
Need for drugs in resuscitation
Drug administration as part of the standard neonatal resuscitation per NRP
Measured: 30 minutes
Use of Chest Compressions
Need for chest compressions as part of neonatal resuscitation per NRP guidelines
Measured: 30 minutes
Use of oxygen
Amount and duration of oxygen use in resuscitation
Measured: 30 minutes
Rate of complications associated with resuscitation
Presence of complications including bleeding, abdominal distension, laryngeal stridor
Measured: 30 minutes
Heart rate 2 minutes after initiation of resuscitation
Heart rate assessed at 2 minutes
Measured: 2 minutes
Maximum inspiratory pressure
Record of highest peak inspiratory pressure used in resuscitation
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study start15 Apr 2018 (estimated)
- Primary completion15 Apr 2018 (estimated)
- Study completion15 Apr 2018 (estimated)
Why it stopped: Study design changed for recruitment purposes; no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arlen Foulks, DO, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629887
- Sponsor's protocol ID
- 5848
- Status last verified
- May 2018
- First submitted
- 10 Dec 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
PubMed 25280870Ersdal HL, Singhal N. Resuscitation in resource-limited settings. Semin Fetal Neonatal Med. 2013 Dec;18(6):373-8. doi: 10.1016/j.siny.2013.07.001. Epub 2013 Jul 27.
PubMed 23896083Wyckoff MH, Perlman JM. Effective ventilation and temperature control are vital to outborn resuscitation. Prehosp Emerg Care. 2004 Apr-Jun;8(2):191-5. doi: 10.1016/j.prehos.2003.12.013.
PubMed 15060855Wyckoff MH, Perlman JM, Laptook AR. Use of volume expansion during delivery room resuscitation in near-term and term infants. Pediatrics. 2005 Apr;115(4):950-5. doi: 10.1542/peds.2004-0913.
PubMed 15805369Ersdal HL, Mduma E, Svensen E, Perlman JM. Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: a prospective descriptive observational study. Resuscitation. 2012 Jul;83(7):869-73. doi: 10.1016/j.resuscitation.2011.12.011. Epub 2011 Dec 23.
PubMed 22198423Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA; Delivery Room Ventilation Devices Trial Group. Comparison of devices for newborn ventilation in the delivery room. J Pediatr. 2014 Aug;165(2):234-239.e3. doi: 10.1016/j.jpeds.2014.02.035. Epub 2014 Mar 29.
PubMed 24690329Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J; American Heart Association. Neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics. 2010 Nov;126(5):e1400-13. doi: 10.1542/peds.2010-2972E. Epub 2010 Oct 18. No abstract available.
PubMed 20956432O'Donnell CP, Davis PG, Morley CJ. Positive pressure ventilation at neonatal resuscitation: review of equipment and international survey of practice. Acta Paediatr. 2004 May;93(5):583-8. doi: 10.1111/j.1651-2227.2004.tb02981.x.
PubMed 15174776Hartung JC, te Pas AB, Fischer H, Schmalisch G, Roehr CC. Leak during manual neonatal ventilation and its effect on the delivered pressures and volumes: an in vitro study. Neonatology. 2012;102(3):190-5. doi: 10.1159/000339325. Epub 2012 Jul 10.
PubMed 22796898Deindl P, O'Reilly M, Zoller K, Berger A, Pollak A, Schwindt J, Schmolzer GM. Influence of mask type and mask position on the effectiveness of bag-mask ventilation in a neonatal manikin. Eur J Pediatr. 2014 Jan;173(1):75-9. doi: 10.1007/s00431-013-2122-4. Epub 2013 Aug 11.
PubMed 23933670Schilleman K, van der Pot CJ, Hooper SB, Lopriore E, Walther FJ, te Pas AB. Evaluating manual inflations and breathing during mask ventilation in preterm infants at birth. J Pediatr. 2013 Mar;162(3):457-63. doi: 10.1016/j.jpeds.2012.09.036. Epub 2012 Oct 25.
PubMed 23102793Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.
PubMed 20547584Foglia EE, Owen LS, Thio M, Ratcliffe SJ, Lista G, Te Pas A, Hummler H, Nadkarni V, Ades A, Posencheg M, Keszler M, Davis P, Kirpalani H. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:95. doi: 10.1186/s13063-015-0601-9.
PubMed 25872563Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J. Part 15: neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S909-19. doi: 10.1161/CIRCULATIONAHA.110.971119. No abstract available.
PubMed 20956231Richmond S, Wyllie J. European Resuscitation Council Guidelines for Resuscitation 2010 Section 7. Resuscitation of babies at birth. Resuscitation. 2010 Oct;81(10):1389-99. doi: 10.1016/j.resuscitation.2010.08.018. No abstract available.
PubMed 20956046
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation: A Pilot Study
- ClinicalTrials.gov ID
- NCT02629887
- Acronym / sponsor ID
- 5848
- Conditions
- Neonatal Resuscitation
- Keywords
- supraglottic airway, neonatal resuscitation, ventilation, term infant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design changed for recruitment purposes; no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 15 Apr 2018 (estimated)
- Primary completion
- 15 Apr 2018 (estimated)
- Study completion
- 15 Apr 2018 (estimated)
- First posted
- 14 Dec 2015 (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.
Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.
Detailed description
Mothers who are close to delivery of a term or near term infant with estimated fetal weight of 2500gms will be approached for consent to randomize their infant to resuscitation with mask or non-inflatable supraglottic airway (NISGA) if resuscitation is required. Study personnel in delivery will open sequential envelopes with randomized code to indicate which device is to be used if necessary. The resuscitator will be blinded until determination of need of respiratory support. At that time, the appropriate randomized device (face mask or NISGA) will be handed to the resuscitator for use along with T-Piece resuscitator. Video data capture will be used to record type, length and response to resuscitation. This information will be translated to a database prior to destruction of video.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face Mask | Active comparator | Device: Face Mask, Device: T-Piece ResuscitatorStandard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline. |
| Non-inflatable supraglottic airway | Active comparator | Device: Non-inflatable supraglottic airway, Device: T-Piece ResuscitatorUse of non-inflating supraglottic airway with T-piece resuscitator instead of Standard Face Mask with T piece resuscitator for neonatal resuscitation, replacing standard of care face mask in Neonatal Resuscitation Program guideline. |
Who may qualify
- Ages
- Up to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns > or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life
Key exclusion criteria (4 listed)
- Newborns with expected fetal weight <2000 grams
- Known congenital malformations
- Multiple gestation (twins and above)
- History of meconium stained 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 |
|---|---|---|
| Non-inflatable supraglottic airwayat delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation. | Device | Non-inflatable supraglottic airway |
| Face Maskat delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask. | Device | Face Mask |
| T-Piece ResuscitatorT-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway | Device | Face Mask, Non-inflatable supraglottic airway |
Primary outcome
Time to Spontaneous Breathing
Time frame: 30 minutes
Record of time from beginning of resuscitation to time of spontaneous breathing
Duration of Positive Pressure Ventilation
Time frame: 30 minutes
Total time of positive pressure ventilation required to adequate spontaneous breathing.
Need for subsequent endotracheal intubation
Time frame: 30 minutes
Failure of non-invasive resuscitative efforts by face mask or NI-SGA requiring intubation per NRP guideline.
7 secondary outcomes
Time needed for NI-SGA placement
Time frame: 1 minute
Need for drugs in resuscitation
Time frame: 30 minutes
Use of Chest Compressions
Time frame: 30 minutes
Use of oxygen
Time frame: 30 minutes
Rate of complications associated with resuscitation
Time frame: 30 minutes
Heart rate 2 minutes after initiation of resuscitation
Time frame: 2 minutes
Maximum inspiratory pressure
Time frame: 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Background: PubMed 25280870Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
- Background: PubMed 23896083Ersdal HL, Singhal N. Resuscitation in resource-limited settings. Semin Fetal Neonatal Med. 2013 Dec;18(6):373-8. doi: 10.1016/j.siny.2013.07.001. Epub 2013 Jul 27.
- Background: PubMed 15060855Wyckoff MH, Perlman JM. Effective ventilation and temperature control are vital to outborn resuscitation. Prehosp Emerg Care. 2004 Apr-Jun;8(2):191-5. doi: 10.1016/j.prehos.2003.12.013.
- Background: PubMed 15805369Wyckoff MH, Perlman JM, Laptook AR. Use of volume expansion during delivery room resuscitation in near-term and term infants. Pediatrics. 2005 Apr;115(4):950-5. doi: 10.1542/peds.2004-0913.
- Background: PubMed 22198423Ersdal HL, Mduma E, Svensen E, Perlman JM. Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: a prospective descriptive observational study. Resuscitation. 2012 Jul;83(7):869-73. doi: 10.1016/j.resuscitation.2011.12.011. Epub 2011 Dec 23.
- Background: PubMed 24690329Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA; Delivery Room Ventilation Devices Trial Group. Comparison of devices for newborn ventilation in the delivery room. J Pediatr. 2014 Aug;165(2):234-239.e3. doi: 10.1016/j.jpeds.2014.02.035. Epub 2014 Mar 29.
- Background: PubMed 20956432Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J; American Heart Association. Neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics. 2010 Nov;126(5):e1400-13. doi: 10.1542/peds.2010-2972E. Epub 2010 Oct 18. No abstract available.
- Background: PubMed 15174776O'Donnell CP, Davis PG, Morley CJ. Positive pressure ventilation at neonatal resuscitation: review of equipment and international survey of practice. Acta Paediatr. 2004 May;93(5):583-8. doi: 10.1111/j.1651-2227.2004.tb02981.x.
- Background: PubMed 22796898Hartung JC, te Pas AB, Fischer H, Schmalisch G, Roehr CC. Leak during manual neonatal ventilation and its effect on the delivered pressures and volumes: an in vitro study. Neonatology. 2012;102(3):190-5. doi: 10.1159/000339325. Epub 2012 Jul 10.
- Background: PubMed 23933670Deindl P, O'Reilly M, Zoller K, Berger A, Pollak A, Schwindt J, Schmolzer GM. Influence of mask type and mask position on the effectiveness of bag-mask ventilation in a neonatal manikin. Eur J Pediatr. 2014 Jan;173(1):75-9. doi: 10.1007/s00431-013-2122-4. Epub 2013 Aug 11.
- Background: PubMed 23102793Schilleman K, van der Pot CJ, Hooper SB, Lopriore E, Walther FJ, te Pas AB. Evaluating manual inflations and breathing during mask ventilation in preterm infants at birth. J Pediatr. 2013 Mar;162(3):457-63. doi: 10.1016/j.jpeds.2012.09.036. Epub 2012 Oct 25.
- Background: PubMed 20547584Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.
- Individual participant dataSharing planned: No
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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.
Arlen Foulks, DO principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-inflatable supraglottic airway, Face Mask and T-Piece Resuscitator in people with Neonatal Resuscitation, run by University of Oklahoma 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 4 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: withdrawn, as of the sponsor's last update on 9 May 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time to Spontaneous Breathing (time frame: 30 minutes). The study lists 3 primary outcomes in all. 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 NCT02629887, which also lists 25 linked publications.
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 9 May 2018.