Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
NCT ID: NCT03369028
Last Updated: 2019-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-04-10
2019-01-30
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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2d and 3D image
A 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec.
2D and 3D image of infants´ faces
2D and 3D image of infants´ faces
Interventions
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2D and 3D image of infants´ faces
2D and 3D image of infants´ faces
Eligibility Criteria
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Inclusion Criteria
* born at the University Hospital of Tuebingen
* signed declaration of consent from the parents
* ≤ 72 hours
Exclusion Criteria
* any respirators or other medical device that covers the face
* missing declaration of consent from the parents
72 Hours
ALL
Yes
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Locations
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University clinic tuebingen
Tübingen, , Germany
Countries
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References
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Singhal 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.
Wyllie 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.
O'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.
O'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.
Schmolzer 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.
Cheung 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.
Kumar 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.
Wood 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.
Wood 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.
Finer 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.
Deindl 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.
O'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.
Krimmel 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.
Krimmel 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.
Farkas LG. Accuracy of anthropometric measurements: past, present, and future. Cleft Palate Craniofac J. 1996 Jan;33(1):10-8; discussion 19-22. doi: 10.1597/1545-1569_1996_033_0010_aoampp_2.3.co_2.
Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. doi: 10.1038/nmeth.2089.
Farkas LG. [Centenary of Ambrus Abraham]. Orv Hetil. 1994 Jun 26;135(26):1429. No abstract available. Hungarian.
Haase B, Badinska AM, Maiwald CA, Poets CF, Springer L. Comparison of nostril sizes of newborn infants with outer diameter of endotracheal tubes. BMC Pediatr. 2021 Sep 23;21(1):417. doi: 10.1186/s12887-021-02889-5.
Haase B, Badinska AM, Koos B, Poets CF, Lorenz L. Do commonly available round facemasks fit near-term and term infants? Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):364-368. doi: 10.1136/archdischild-2019-317531. Epub 2019 Sep 21.
Other Identifiers
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CAFF
Identifier Type: -
Identifier Source: org_study_id
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