Preterm Infant Clinical Trial
— CAFFOfficial title:
Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
NCT number | NCT03369028 |
Other study ID # | CAFF |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 10, 2018 |
Est. completion date | January 30, 2019 |
Verified date | November 2017 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 100 |
Est. completion date | January 30, 2019 |
Est. primary completion date | January 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University clinic tuebingen | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Cheung D, Mian Q, Cheung PY, O'Reilly M, Aziz K, van Os S, Pichler G, Schmölzer 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. — View Citation
Deindl P, Schwindt J, Berger A, Schmölzer 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. — View Citation
Farkas LG. [Centenary of Ambrus Abrahám]. Orv Hetil. 1994 Jun 26;135(26):1429. Hungarian. — View Citation
Farkas LG. Accuracy of anthropometric measurements: past, present, and future. Cleft Palate Craniofac J. 1996 Jan;33(1):10-8; discussion 19-22. Review. — View Citation
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. — View Citation
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. — View Citation
Krimmel M, Kluba S, Breidt M, Bacher M, Müller-Hagedorn S, Dietz K, Bülthoff 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. — View Citation
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. — View Citation
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. Epub 2005 May 4. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Schmölzer 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. — View Citation
Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. — View Citation
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. — View Citation
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. Epub 2007 Nov 26. — View Citation
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. Review. — View Citation
Wyllie J, Bruinenberg J, Roehr CC, Rüdiger 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. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Primary | 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. | 1 year | |
Primary | 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. | 1 year | |
Primary | 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. | 1 year | |
Secondary | Gestational age | Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware. | 1 year | |
Secondary | Birth weight | Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware. | 1 year | |
Secondary | headcircumference | Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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.. | 1 year |
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