Fitting of Commonly Available Face Masks for Late Preterm and Term Infants (CAFF)
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).
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Tuebingen、ドイツ、72072
- University clinic tuebingen
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
- 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
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- congenital facial anomalies
- any respirators or other medical device that covers the face
- missing declaration of consent from the parents
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
2d and 3D image
A 2D and 3D image of the participants' face will be taken.
It will at least last 2-3 sec.
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2D and 3D image of infants´ faces
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mouth: Find out the best fitting facemask
時間枠：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.
|
1 year
|
|
Lips: Find out the best fitting facemask
時間枠：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.
|
1 year
|
|
Eyes: Find out the best fitting facemask
時間枠：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.
|
1 year
|
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Chin: Find out the best fitting facemask
時間枠：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.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gestational age
時間枠：1 year
|
Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
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1 year
|
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Birth weight
時間枠：1 year
|
Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
|
1 year
|
|
headcircumference
時間枠：1 year
|
Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
|
1 year
|
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gender: male/female
時間枠：1 year
|
Correlation between gender (male/female) and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
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1 year
|
|
way of delivery: spontaneous/cesarean
時間枠：1 year
|
Correlation between way of delivery and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware..
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1 year
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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