FaceCAFFNCT03369028
Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
An observational study of Face and Newborn, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating bag or flow-inflating bag. Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Face, Newborn, Preterm Infant
- What is being tested?
- 2D and 3D image of infants´ faces
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 10 Apr 2018to 30 Jan 2019
- Phase
- Observational
- 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 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Late preterm and term infants, gestational week ≥ 34 +0 * 10 to 15 patients in every gestational-week * born at the University Hospital of Tuebingen * signed declaration of consent from the parents * ≤ 72 hours
Who may be able to join
- Late preterm and term infants, gestational week ≥ 34 +0
- born at the University Hospital of Tuebingen
- signed declaration of consent from the parents
- ≤ 72 hours
Who cannot join
- congenital facial anomalies
- any respirators or other medical device that covers the face
- missing declaration of consent from the parents
Trial locations and contacts
1 site in 1 country.
About this study
Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating bag or flow-inflating bag. Face mask ventilation is a challenging technique and difficult to ensure that an appropriate tidal volume is delivered because large and variable leaks occur between the mask and face.
It is recommended by International Guidelines to start with mask ventilation by placing a fitting face mask on the babies face.
Read more
A fitting face mask covers the mouth and nose. A non-fitting overlaps the eyes and the chin, which causes a airleak. Studies report variable leak, sometimes more than 50% of inspiratory volume, during PPV in preterm infants in the delivery room. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation.
A study performed in preterm infants showed that most masks available are too big for the majority of those infants.
The investigators hypothesis is that the commonly available face masks for term infants are similarly too big for some term and late preterm infants (≥ 34 weeks gestation).
Read the detailed description
The investigators would like to measure the dimensions of the faces of late preterm and term infants (≥ 34 SSW) within the first 72 hours of life and compare this data with the size of the most recommended available face masks:
VBM Germany:
external diameter smaller mask: 50 mm, external diameter bigger mask: 70 m
Laerdal:
external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm
Fisher\&Paykel:
external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm
Therefore the investigators want to collect the following information from the participants:
Picture of the participant´s face (2D and 3D-Image) birth weight, head circumference, mode of delivery, gestational age, singletons/ twins/ triplets, date of birth
- Conditions
- Face, Newborn, Preterm Infant
- Being tested
- 2D and 3D image of infants´ faces
- Medical subject headings
- Facies, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D and 3D image of infants´ facesOther
2D and 3D image of infants´ faces
| Study group | Role | What they receive |
|---|---|---|
| 2d and 3D image | A 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec. Receives: Other: 2D and 3D image of infants´ faces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth: Find out the best fitting facemask
Measure distance in millimeters with ImageJ and 3DMaxSoftware from the nasofrontal groove to the mental protuberance and determine if the commonly available face masks fit this study population.
Measured: 1 year
Lips: Find out the best fitting facemask
Measure the lateral points located at each labial commissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
Measured: 1 year
Eyes: Find out the best fitting facemask
Measure the points at the inner commissure of the eye fissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
Measured: 1 year
Chin: Find out the best fitting facemask
Measure length of the chin in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
Measured: 1 year
Secondary outcomes (5)
Gestational age
Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Measured: 1 year
Birth weight
Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Measured: 1 year
headcircumference
Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Measured: 1 year
gender: male/female
Correlation between gender (male/female) and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
Measured: 1 year
way of delivery: spontaneous/cesarean
Correlation between way of delivery and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware..
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start10 Apr 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for FaceStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369028
- Sponsor's protocol ID
- CAFF
- Acronym
- CAFF
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sawyer T, Umoren RA, Gray MM. Neonatal resuscitation: advances in training and practice. Adv Med Educ Pract. 2016 Dec 23;8:11-19. doi: 10.2147/AMEP.S109099. eCollection 2017.
PubMed 28096704Singhal N, McMillan DD, Yee WH, Akierman AR, Yee YJ. Evaluation of the effectiveness of the standardized neonatal resuscitation program. J Perinatol. 2001 Sep;21(6):388-92. doi: 10.1038/sj.jp.7210551.
PubMed 11593374Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
PubMed 26477415O'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 15174776O'Donnell CP, Davis PG, Lau R, Dargaville PA, Doyle LW, Morley CJ. Neonatal resuscitation 2: an evaluation of manual ventilation devices and face masks. Arch Dis Child Fetal Neonatal Ed. 2005 Sep;90(5):F392-6. doi: 10.1136/adc.2004.064691. Epub 2005 May 4.
PubMed 15871989Schmolzer 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 20547584Cheung D, Mian Q, Cheung PY, O'Reilly M, Aziz K, van Os S, Pichler G, Schmolzer GM. Mask ventilation with two different face masks in the delivery room for preterm infants: a randomized controlled trial. J Perinatol. 2015 Jul;35(7):464-8. doi: 10.1038/jp.2015.8. Epub 2015 Feb 26.
PubMed 25719544Kumar VH, Skrobacz A, Ma C. Impact of bradycardia or asystole on neonatal cardiopulmonary resuscitation at birth. Pediatr Int. 2017 Aug;59(8):891-897. doi: 10.1111/ped.13310. Epub 2017 Jul 9.
PubMed 28452098Wood FE, Morley CJ, Dawson JA, Kamlin CO, Owen LS, Donath S, Davis PG. Improved techniques reduce face mask leak during simulated neonatal resuscitation: study 2. Arch Dis Child Fetal Neonatal Ed. 2008 May;93(3):F230-4. doi: 10.1136/adc.2007.117788. Epub 2007 Nov 26.
PubMed 18039750Wood FE, Morley CJ. Face mask ventilation--the dos and don'ts. Semin Fetal Neonatal Med. 2013 Dec;18(6):344-51. doi: 10.1016/j.siny.2013.08.009. Epub 2013 Sep 14.
PubMed 24041823Finer NN, Rich W, Wang C, Leone T. Airway obstruction during mask ventilation of very low birth weight infants during neonatal resuscitation. Pediatrics. 2009 Mar;123(3):865-9. doi: 10.1542/peds.2008-0560.
PubMed 19255015Deindl P, Schwindt J, Berger A, Schmolzer GM. An instructional video enhanced bag-mask ventilation quality during simulated newborn resuscitation. Acta Paediatr. 2015 Jan;104(1):e20-6. doi: 10.1111/apa.12826. Epub 2014 Oct 30.
PubMed 25308155O'Shea JE, Thio M, Owen LS, Wong C, Dawson JA, Davis PG. Measurements from preterm infants to guide face mask size. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F294-8. doi: 10.1136/archdischild-2014-307350. Epub 2015 Apr 10.
PubMed 25862726Krimmel M, Kluba S, Breidt M, Bacher M, Dietz K, Buelthoff H, Reinert S. Three-dimensional assessment of facial development in children with Pierre Robin sequence. J Craniofac Surg. 2009 Nov;20(6):2055-60. doi: 10.1097/SCS.0b013e3181be87db.
PubMed 19881369Krimmel M, Kluba S, Breidt M, Bacher M, Muller-Hagedorn S, Dietz K, Bulthoff H, Reinert S. Three-dimensional assessment of facial development in children with unilateral cleft lip with and without alveolar cleft. J Craniofac Surg. 2013 Jan;24(1):313-6. doi: 10.1097/SCS.0b013e318275ed60.
PubMed 23348308
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT03369028
- Acronym / sponsor ID
- CAFF / CAFF
- Conditions
- Face, Newborn, Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- 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.
Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating bag or flow-inflating bag. Face mask ventilation is a challenging technique and difficult to ensure that an appropriate tidal volume is delivered because large and variable leaks occur between the mask and face.
It is recommended by International Guidelines to start with mask ventilation by placing a fitting face mask on the babies face.
A fitting face mask covers the mouth and nose. A non-fitting overlaps the eyes and the chin, which causes a airleak. Studies report variable leak, sometimes more than 50% of inspiratory volume, during PPV in preterm infants in the delivery room. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation.
A study performed in preterm infants showed that most masks available are too big for the majority of those infants.
The investigators hypothesis is that the commonly available face masks for term infants are similarly too big for some term and late preterm infants (≥ 34 weeks gestation).
Detailed description
The investigators would like to measure the dimensions of the faces of late preterm and term infants (≥ 34 SSW) within the first 72 hours of life and compare this data with the size of the most recommended available face masks:
VBM Germany:
external diameter smaller mask: 50 mm, external diameter bigger mask: 70 m
Laerdal:
external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm
Fisher\&Paykel:
external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm
Therefore the investigators want to collect the following information from the participants:
Picture of the participant´s face (2D and 3D-Image) birth weight, head circumference, mode of delivery, gestational age, singletons/ twins/ triplets, date of birth
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2d and 3D image | – | Other: 2D and 3D image of infants´ facesA 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec. |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Late preterm and term infants, gestational week ≥ 34 +0 * 10 to 15 patients in every gestational-week * born at the University Hospital of Tuebingen * signed declaration of consent from the parents * ≤ 72 hours
Key inclusion criteria (4 listed)
- Late preterm and term infants, gestational week ≥ 34 +0
- born at the University Hospital of Tuebingen
- signed declaration of consent from the parents
- ≤ 72 hours
Key exclusion criteria (3 listed)
- congenital facial anomalies
- any respirators or other medical device that covers the face
- missing declaration of consent from the parents
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 |
|---|---|---|
| 2D and 3D image of infants´ faces2D and 3D image of infants´ faces | Other | 2d and 3D image |
Primary outcome
Mouth: Find out the best fitting facemask
Time frame: 1 year
Measure distance in millimeters with ImageJ and 3DMaxSoftware from the nasofrontal groove to the mental protuberance and determine if the commonly available face masks fit this study population.
Lips: Find out the best fitting facemask
Time frame: 1 year
Measure the lateral points located at each labial commissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
Eyes: Find out the best fitting facemask
Time frame: 1 year
Measure the points at the inner commissure of the eye fissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
Chin: Find out the best fitting facemask
Time frame: 1 year
Measure length of the chin in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
5 secondary outcomes
Gestational age
Time frame: 1 year
Birth weight
Time frame: 1 year
headcircumference
Time frame: 1 year
gender: male/female
Time frame: 1 year
way of delivery: spontaneous/cesarean
Time frame: 1 year
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 30 May 2019.
- Background: PubMed 28096704Sawyer T, Umoren RA, Gray MM. Neonatal resuscitation: advances in training and practice. Adv Med Educ Pract. 2016 Dec 23;8:11-19. doi: 10.2147/AMEP.S109099. eCollection 2017.
- Background: PubMed 11593374Singhal N, McMillan DD, Yee WH, Akierman AR, Yee YJ. Evaluation of the effectiveness of the standardized neonatal resuscitation program. J Perinatol. 2001 Sep;21(6):388-92. doi: 10.1038/sj.jp.7210551.
- Background: PubMed 26477415Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. 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 15871989O'Donnell CP, Davis PG, Lau R, Dargaville PA, Doyle LW, Morley CJ. Neonatal resuscitation 2: an evaluation of manual ventilation devices and face masks. Arch Dis Child Fetal Neonatal Ed. 2005 Sep;90(5):F392-6. doi: 10.1136/adc.2004.064691. Epub 2005 May 4.
- 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.
- Background: PubMed 25719544Cheung D, Mian Q, Cheung PY, O'Reilly M, Aziz K, van Os S, Pichler G, Schmolzer GM. Mask ventilation with two different face masks in the delivery room for preterm infants: a randomized controlled trial. J Perinatol. 2015 Jul;35(7):464-8. doi: 10.1038/jp.2015.8. Epub 2015 Feb 26.
- Background: PubMed 28452098Kumar VH, Skrobacz A, Ma C. Impact of bradycardia or asystole on neonatal cardiopulmonary resuscitation at birth. Pediatr Int. 2017 Aug;59(8):891-897. doi: 10.1111/ped.13310. Epub 2017 Jul 9.
- Background: PubMed 18039750Wood FE, Morley CJ, Dawson JA, Kamlin CO, Owen LS, Donath S, Davis PG. Improved techniques reduce face mask leak during simulated neonatal resuscitation: study 2. Arch Dis Child Fetal Neonatal Ed. 2008 May;93(3):F230-4. doi: 10.1136/adc.2007.117788. Epub 2007 Nov 26.
- Background: PubMed 24041823Wood FE, Morley CJ. Face mask ventilation--the dos and don'ts. Semin Fetal Neonatal Med. 2013 Dec;18(6):344-51. doi: 10.1016/j.siny.2013.08.009. Epub 2013 Sep 14.
- Background: PubMed 19255015Finer NN, Rich W, Wang C, Leone T. Airway obstruction during mask ventilation of very low birth weight infants during neonatal resuscitation. Pediatrics. 2009 Mar;123(3):865-9. doi: 10.1542/peds.2008-0560.
- Background: PubMed 25308155Deindl P, Schwindt J, Berger A, Schmolzer GM. An instructional video enhanced bag-mask ventilation quality during simulated newborn resuscitation. Acta Paediatr. 2015 Jan;104(1):e20-6. doi: 10.1111/apa.12826. Epub 2014 Oct 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Face and Newborn, run by University Hospital Tuebingen at 1 site in Germany.
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 4 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 30 May 2019. 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 Germany. 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?
Mouth: Find out the best fitting facemask (time frame: 1 year). The study lists 4 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 NCT03369028, which also lists 20 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 30 May 2019.